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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00279201
Registration number
NCT00279201
Ethics application status
Date submitted
15/12/2005
Date registered
19/01/2006
Date last updated
21/02/2011
Titles & IDs
Public title
The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
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Scientific title
The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control
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Secondary ID [1]
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F3Z-US-IOOV
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Secondary ID [2]
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10455
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Universal Trial Number (UTN)
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Trial acronym
IOOV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Insulin glargine
Treatment: Drugs - Lispro Low Mix
Treatment: Drugs - Lispro Mid Mix
Treatment: Drugs - Lispro
Active comparator: Insulin glargine - Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
Experimental: Lispro Low Mix - Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Experimental: Lispro Mid Mix prior Lispro Low Mix addendum - Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
Experimental: Lispro Low Mix prior Glargine addendum - Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase
Active comparator: Basal bolus prior Lispro Low Mix addendum - Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Active comparator: Basal bolus prior Glargine addendum - Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Treatment: Drugs: Insulin glargine
Subcutaneous injection daily
Treatment: Drugs: Lispro Low Mix
Subcutaneous injection twice daily.
Treatment: Drugs: Lispro Mid Mix
Lispro Mid Mix subcutaneous injection 3 times daily.
Treatment: Drugs: Lispro
Lispro subcutaneous injection 3 times daily.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)
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Assessment method [1]
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Timepoint [1]
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Endpoint (Initiation: Week 24)
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Primary outcome [2]
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MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
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Assessment method [2]
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HbA1c goal: HbA1c =7.0% or HbA1c \>7.0% but increased \<0.4% from last HbA1c =7.0%
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Timepoint [2]
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Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)
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Primary outcome [3]
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ADDENDUM: 24-Week Endpoint HbA1c
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Assessment method [3]
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HbA1c at 24-week endpoint in Intensification Addendum of the trial.
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Timepoint [3]
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Endpoint (Addendum) (24 weeks: Week 48)
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Secondary outcome [1]
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INITIATION: Change in HbA1c From Baseline to 24 Weeks
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Assessment method [1]
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Timepoint [1]
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Baseline (Initiation) to Endpoint (LOCF, Week 24)
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Secondary outcome [2]
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INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
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Assessment method [2]
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Timepoint [2]
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Endpoint (Initiation: Week 24)
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Secondary outcome [3]
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INITIATION: HbA1c
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Assessment method [3]
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Timepoint [3]
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Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)
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Secondary outcome [4]
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INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
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Assessment method [4]
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Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
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Timepoint [4]
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Endpoint (LOCF) (Initiation: Week 24)
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Secondary outcome [5]
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INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)
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Assessment method [5]
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Timepoint [5]
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Baseline (Initiation), Endpoint (Week 24)
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Secondary outcome [6]
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INITIATION: Incremental Change From Baseline in Body Weight
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Assessment method [6]
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Timepoint [6]
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Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
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Secondary outcome [7]
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INITIATION: Body Weight
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Assessment method [7]
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Timepoint [7]
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Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
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Secondary outcome [8]
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INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
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Assessment method [8]
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Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
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Timepoint [8]
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Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).
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Secondary outcome [9]
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INITIATION: Rate of Self-reported Hypoglycemic Episodes
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Assessment method [9]
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Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
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Timepoint [9]
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Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
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Secondary outcome [10]
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INITIATION: Insulin Dose
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Assessment method [10]
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Timepoint [10]
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Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)
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Secondary outcome [11]
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
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Assessment method [11]
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Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%).
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Timepoint [11]
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Endpoint (Initiation: Week 24)
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Secondary outcome [12]
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
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Assessment method [12]
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Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%).
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Timepoint [12]
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Endpoint (Initiation: Week 24)
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Secondary outcome [13]
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
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Assessment method [13]
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Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c =7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) \* fasting plasma glucose (millimoles per liter) / 22.5.
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Timepoint [13]
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Endpoint (Initiation: Week 24)
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Secondary outcome [14]
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
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Assessment method [14]
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Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%).
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Timepoint [14]
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Endpoint (Initiation: Week 24)
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Secondary outcome [15]
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
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Assessment method [15]
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Comparison of baseline HbA1c percentage group (\<8.5,\>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%).
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Timepoint [15]
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Endpoint (Initiation: Week 24)
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Secondary outcome [16]
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
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Assessment method [16]
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Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%).
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Timepoint [16]
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Endpoint (Initiation: Week 24)
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Secondary outcome [17]
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
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Assessment method [17]
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Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%).
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Timepoint [17]
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Endpoint (Initiation: Week 24)
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Secondary outcome [18]
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
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Assessment method [18]
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Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%).
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Timepoint [18]
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Endpoint (Initiation: Week 24)
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Secondary outcome [19]
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MAINTENANCE: HbA1c at Specified Visits and Endpoint
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Assessment method [19]
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Timepoint [19]
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Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)
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Secondary outcome [20]
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MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
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Assessment method [20]
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Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
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Timepoint [20]
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Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
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Secondary outcome [21]
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MAINTENANCE: Rate of Increase in HbA1c
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Assessment method [21]
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Rate of increase: HbA1c change/time period (month).
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Timepoint [21]
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Endpoint (LOCF) (Maintenance: up to 2.5 years)
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Secondary outcome [22]
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MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
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Assessment method [22]
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Timepoint [22]
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Endpoint (LOCF) (Maintenance: up to 2.5 years)
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Secondary outcome [23]
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MAINTENANCE: Incremental Change From Baseline in Body Weight
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Assessment method [23]
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Timepoint [23]
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Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [24]
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MAINTENANCE: Body Weight
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Assessment method [24]
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Timepoint [24]
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Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [25]
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MAINTENANCE: Insulin Dose
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Assessment method [25]
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Timepoint [25]
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Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [26]
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MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
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Assessment method [26]
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Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
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Timepoint [26]
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Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)
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Secondary outcome [27]
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MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
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Assessment method [27]
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Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
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Timepoint [27]
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Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
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Secondary outcome [28]
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MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
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Assessment method [28]
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Timepoint [28]
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Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
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Secondary outcome [29]
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MAINTENANCE: Change From Baseline to Endpoint in HbA1c
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Assessment method [29]
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Timepoint [29]
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Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [30]
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
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Assessment method [30]
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Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [30]
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [31]
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
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Assessment method [31]
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Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [31]
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [32]
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
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Assessment method [32]
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Comparison of duration of diabetes group (\<10, 10-\<20, \>=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [32]
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [33]
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
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Assessment method [33]
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Comparison of duration of diabetes group (\<10, 10-\<20, \>=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [33]
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [34]
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
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Assessment method [34]
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Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [34]
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [35]
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
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Assessment method [35]
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Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [35]
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [36]
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
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Assessment method [36]
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Comparison of baseline HbA1c group (\<8.5,\>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [36]
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [37]
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
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Assessment method [37]
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Comparison of baseline HbA1c group (\<8.5,\>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [37]
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0
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [38]
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
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Assessment method [38]
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Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [38]
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0
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [39]
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
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Assessment method [39]
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Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [39]
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0
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [40]
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
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Assessment method [40]
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Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [40]
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0
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [41]
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
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Assessment method [41]
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Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [41]
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0
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [42]
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
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Assessment method [42]
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Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [42]
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0
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [43]
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
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Assessment method [43]
0
0
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
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Timepoint [43]
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0
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Secondary outcome [44]
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ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
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Assessment method [44]
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Timepoint [44]
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Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])
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Secondary outcome [45]
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ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
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Assessment method [45]
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Query!
Timepoint [45]
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Endpoint (Addendum: 24 weeks [Week 48])
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Secondary outcome [46]
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0
ADDENDUM: 7-point SMPG Profiles
Query!
Assessment method [46]
0
0
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Query!
Timepoint [46]
0
0
Endpoint (Addendum: 24 weeks [Week 48])
Query!
Secondary outcome [47]
0
0
ADDENDUM: Incremental Change From Baseline in Body Weight
Query!
Assessment method [47]
0
0
Query!
Timepoint [47]
0
0
Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)
Query!
Secondary outcome [48]
0
0
ADDENDUM: Body Weight
Query!
Assessment method [48]
0
0
Query!
Timepoint [48]
0
0
Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
Query!
Secondary outcome [49]
0
0
ADDENDUM: Insulin Dose
Query!
Assessment method [49]
0
0
Query!
Timepoint [49]
0
0
Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
Query!
Secondary outcome [50]
0
0
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Query!
Assessment method [50]
0
0
Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Query!
Timepoint [50]
0
0
Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
Query!
Secondary outcome [51]
0
0
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Query!
Assessment method [51]
0
0
Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Query!
Timepoint [51]
0
0
Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase
Query!
Secondary outcome [52]
0
0
ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
Query!
Assessment method [52]
0
0
Query!
Timepoint [52]
0
0
Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)
Query!
Secondary outcome [53]
0
0
ADDENDUM: HbA1c at Specified Visits and Endpoint
Query!
Assessment method [53]
0
0
Query!
Timepoint [53]
0
0
Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)
Query!
Eligibility
Key inclusion criteria
* Must have type 2 diabetes.
* Must be at least 30 and less than 80 years of age at the time of Visit 1.
* Must be on at least two oral antidiabetes medications for at least 90 days.
* Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.
Query!
Minimum age
30
Years
Query!
Query!
Maximum age
79
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Must not have used insulin on a regular basis in the last 12 months.
* Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
* Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
* Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
* Must not be pregnant or intend to get pregnant during course of the study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2091
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Kingswood Penrith
Query!
Recruitment hospital [2]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Elizabeth Vale
Query!
Recruitment hospital [3]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Keswick
Query!
Recruitment hospital [4]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Burnie
Query!
Recruitment hospital [5]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Box Hill
Query!
Recruitment hospital [6]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2747 - Kingswood Penrith
Query!
Recruitment postcode(s) [2]
0
0
5112 - Elizabeth Vale
Query!
Recruitment postcode(s) [3]
0
0
5035 - Keswick
Query!
Recruitment postcode(s) [4]
0
0
7320 - Burnie
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Recruitment postcode(s) [5]
0
0
3128 - Box Hill
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Recruitment postcode(s) [6]
0
0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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0
0
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0
0
Arizona
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0
0
United States of America
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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0
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South Carolina
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0
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0
Tennessee
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0
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0
0
Texas
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0
0
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0
Utah
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0
United States of America
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0
0
Vermont
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0
0
United States of America
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State/province [38]
0
0
Washington
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0
0
United States of America
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0
0
Wisconsin
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0
0
Argentina
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0
0
Buenos Aires
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0
0
Argentina
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0
0
Mar Del Plata
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0
0
Argentina
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0
0
Pilar
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0
0
Brazil
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0
0
Curitiba
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0
0
Brazil
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0
0
Porto Alegre
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0
0
Brazil
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0
0
Setor Oeste/Goiania
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0
0
Brazil
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State/province [46]
0
0
São Paulo
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0
0
Canada
Query!
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0
0
Alberta
Query!
Country [48]
0
0
Canada
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0
0
Manitoba
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Country [49]
0
0
Canada
Query!
State/province [49]
0
0
New Brunswick
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Country [50]
0
0
Canada
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State/province [50]
0
0
Ontario
Query!
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0
0
Canada
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0
0
Quebec
Query!
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0
0
Greece
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0
0
Athens
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0
0
Greece
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0
0
Nikaias - Piraeus
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0
Greece
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0
0
Thessaloniki
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0
0
Hungary
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0
0
Eger
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Country [56]
0
0
Hungary
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0
0
Pecs
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Country [57]
0
0
Hungary
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State/province [57]
0
0
Szekszard
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0
0
Hungary
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0
0
Szentes
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Country [59]
0
0
India
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0
0
Ahemdabad
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Country [60]
0
0
India
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State/province [60]
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0
Aligarh
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Country [61]
0
0
India
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State/province [61]
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0
Bangalore
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Country [62]
0
0
India
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0
Coimbatore
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Country [63]
0
0
India
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0
Hyderabaad
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0
0
India
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0
Karnal/Haryana
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0
India
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Trivandrum
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0
Netherlands
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Amsterdam
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Netherlands
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Brunssum
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Netherlands
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Emmen
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0
Netherlands
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Hoogeveen
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0
Netherlands
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Nijmegen
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Netherlands
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Venlo
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Netherlands
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0
Zwijndrecht
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Puerto Rico
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Bayamon
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Puerto Rico
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Carolina
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Puerto Rico
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Orcorvis
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Puerto Rico
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Ponce
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Puerto Rico
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Rio Piedras
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Puerto Rico
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San Juan
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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Targu-Mures
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Romania
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Timisoara
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Spain
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Alcira
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Spain
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Dos Hermanas
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Mosteles
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Spain
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Requena
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0
Spain
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State/province [90]
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0
Santander
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled. This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications. The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.
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Trial website
https://clinicaltrials.gov/study/NCT00279201
Query!
Trial related presentations / publications
Herman WH, Dungan KM, Wolffenbuttel BH, Buse JB, Fahrbach JL, Jiang H, Martin S. Racial and ethnic differences in mean plasma glucose, hemoglobin A1c, and 1,5-anhydroglucitol in over 2000 patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 May;94(5):1689-94. doi: 10.1210/jc.2008-1940. Epub 2009 Mar 10. Fahrbach J, Jacober S, Jiang H, Martin S. The DURABLE trial study design: comparing the safety, efficacy, and durability of insulin glargine to insulin lispro mix 75/25 added to oral antihyperglycemic agents in patients with type 2 diabetes. J Diabetes Sci Technol. 2008 Sep;2(5):831-8. doi: 10.1177/193229680800200514. Scheen AJ, Schmitt H, Jiang HH, Ivanyi T. Individualizing treatment of type 2 diabetes by targeting postprandial or fasting hyperglycaemia: Response to a basal vs a premixed insulin regimen by HbA1c quartiles and ethnicity. Diabetes Metab. 2015 Jun;41(3):216-22. doi: 10.1016/j.diabet.2015.03.002. Epub 2015 Apr 14. Jovanovic L, Peters AL, Jiang HH, Hardin DS. Durability of glycemic control with insulin lispro mix 75/25 versus insulin glargine for older patients with type 2 diabetes. Aging Clin Exp Res. 2014 Apr;26(2):115-21. doi: 10.1007/s40520-013-0140-8. Epub 2013 Oct 3. Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):2931-6. doi: 10.2337/dc12-2711. Epub 2013 Jun 11. Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099. Buse JB, Wolffenbuttel BH, Herman WH, Hippler S, Martin SA, Jiang HH, Shenouda SK, Fahrbach JL. The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine. Diabetes Care. 2011 Feb;34(2):249-55. doi: 10.2337/dc10-1701. Miser WF, Arakaki R, Jiang H, Scism-Bacon J, Anderson PW, Fahrbach JL. Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: a noninferiority intensification substudy of the DURABLE trial. Clin Ther. 2010 May;32(5):896-908. doi: 10.1016/j.clinthera.2010.05.001. Wolffenbuttel BH, Klaff LJ, Bhushan R, Fahrbach JL, Jiang H, Martin S. Initiating insulin therapy in elderly patients with Type 2 diabetes: efficacy and safety of lispro mix 25 vs. basal insulin combined with oral glucose-lowering agents. Diabet Med. 2009 Nov;26(11):1147-55. doi: 10.1111/j.1464-5491.2009.02824.x. Buse JB, Wolffenbuttel BH, Herman WH, Shemonsky NK, Jiang HH, Fahrbach JL, Scism-Bacon JL, Martin SA. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1007-13. doi: 10.2337/dc08-2117. Epub 2009 Mar 31.
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Public notes
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Contacts
Principal investigator
Name
0
0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
0
0
Eli Lilly and Company
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
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0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Herman WH, Dungan KM, Wolffenbuttel BH, Buse JB, F...
[
More Details
]
Journal
Fahrbach J, Jacober S, Jiang H, Martin S. The DURA...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00279201
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