Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00377858
Registration number
NCT00377858
Ethics application status
Date submitted
11/09/2006
Date registered
19/09/2006
Date last updated
9/12/2009
Titles & IDs
Public title
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)
Query!
Scientific title
Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections
Query!
Secondary ID [1]
0
0
F3Z-MC-IOOX
Query!
Secondary ID [2]
0
0
10936
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
IOOX
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Insulin lispro mid mixture (MM)
Treatment: Drugs - Insulin glargine
Experimental: Insulin Lispro Mid Mixture - Insulin lispro mid mixture (MM) up to three times a day (TID)
Active comparator: Insulin Glargine - Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
Treatment: Drugs: Insulin lispro mid mixture (MM)
Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
Treatment: Drugs: Insulin glargine
Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Hemoglobin A1c (HbA1c) at 36 Week Endpoint
Query!
Assessment method [1]
0
0
Level of hemoglobin A1c at endpoint.
Query!
Timepoint [1]
0
0
36 weeks
Query!
Secondary outcome [1]
0
0
Hemoglobin A1c (HbA1c) at Interval Visits
Query!
Assessment method [1]
0
0
Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.
Query!
Timepoint [1]
0
0
12, 24, and 36 weeks
Query!
Secondary outcome [2]
0
0
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
12-24-36 weeks
Query!
Secondary outcome [3]
0
0
7-point Self-monitored Blood Glucose Profiles
Query!
Assessment method [3]
0
0
Actual daily mean blood glucose levels at specified time points.
Query!
Timepoint [3]
0
0
Baseline, 12-24-36 weeks
Query!
Secondary outcome [4]
0
0
Glycemic Variability
Query!
Assessment method [4]
0
0
Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.
Query!
Timepoint [4]
0
0
Baseline, 12-24-36 weeks
Query!
Secondary outcome [5]
0
0
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Query!
Assessment method [5]
0
0
Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Query!
Timepoint [5]
0
0
Baseline to 36 Weeks
Query!
Secondary outcome [6]
0
0
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Query!
Assessment method [6]
0
0
Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Query!
Timepoint [6]
0
0
Baseline to 36 Weeks
Query!
Secondary outcome [7]
0
0
Number of Patients With at Least One Severe Hypoglycemia Episode
Query!
Assessment method [7]
0
0
Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose \<2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Query!
Timepoint [7]
0
0
Baseline to 36 Weeks
Query!
Secondary outcome [8]
0
0
Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Query!
Assessment method [8]
0
0
Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day \[U/kg/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.
Query!
Timepoint [8]
0
0
36 Weeks
Query!
Secondary outcome [9]
0
0
Endpoint Insulin Dose; Total, Basal, and Prandial
Query!
Assessment method [9]
0
0
Total daily insulin dose (Units of insulin per day \[U/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.
Query!
Timepoint [9]
0
0
36 Weeks
Query!
Secondary outcome [10]
0
0
Number of Insulin Injections Per Day
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Weeks 12, 24, 30, 36
Query!
Secondary outcome [11]
0
0
Change From Baseline in Absolute Body Weight at 36 Week Endpoint
Query!
Assessment method [11]
0
0
Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.
Query!
Timepoint [11]
0
0
Baseline, 36 Weeks
Query!
Eligibility
Key inclusion criteria
* Have type 2 diabetes
* Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
* Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.
Query!
Minimum age
30
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
* Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
* Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
* Have a body mass index greater than 40 kg/m2.
* Have had more than one episode of severe hypoglycemia in the last24 weeks
* Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
* Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
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
1/08/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
484
Query!
Recruitment in Australia
Recruitment state(s)
SA,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. - Keswick
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. - Fitzroy
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. - Fremantle
Query!
Recruitment postcode(s) [1]
0
0
5035 - Keswick
Query!
Recruitment postcode(s) [2]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
6160 - Fremantle
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
Ontario
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Quebec
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
Saskatchewan
Query!
Country [4]
0
0
France
Query!
State/province [4]
0
0
Mantes La Jolie
Query!
Country [5]
0
0
France
Query!
State/province [5]
0
0
Menton
Query!
Country [6]
0
0
France
Query!
State/province [6]
0
0
Pau
Query!
Country [7]
0
0
France
Query!
State/province [7]
0
0
Poitiers
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Toulouse
Query!
Country [9]
0
0
Korea, Republic of
Query!
State/province [9]
0
0
Goyang-Si/Kyunggi-Do
Query!
Country [10]
0
0
Korea, Republic of
Query!
State/province [10]
0
0
Kwang Ju
Query!
Country [11]
0
0
Korea, Republic of
Query!
State/province [11]
0
0
Seoul
Query!
Country [12]
0
0
Mexico
Query!
State/province [12]
0
0
Chihuahua
Query!
Country [13]
0
0
Mexico
Query!
State/province [13]
0
0
Guadalajara
Query!
Country [14]
0
0
Russian Federation
Query!
State/province [14]
0
0
Arkhangelsk
Query!
Country [15]
0
0
Russian Federation
Query!
State/province [15]
0
0
Moscow
Query!
Country [16]
0
0
Russian Federation
Query!
State/province [16]
0
0
Saint Petersburg
Query!
Country [17]
0
0
Spain
Query!
State/province [17]
0
0
Alicante
Query!
Country [18]
0
0
Spain
Query!
State/province [18]
0
0
Almeria
Query!
Country [19]
0
0
Spain
Query!
State/province [19]
0
0
Barcelona
Query!
Country [20]
0
0
Spain
Query!
State/province [20]
0
0
Bilbao
Query!
Country [21]
0
0
Spain
Query!
State/province [21]
0
0
Malaga
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00377858
Query!
Trial related presentations / publications
Hayes RP, Curtis B, Ilag L, Nelson DR, Wong M, Funnell M. Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy. J Diabetes. 2013 Sep;5(3):358-67. doi: 10.1111/1753-0407.12037. Epub 2013 May 28.
Query!
Public notes
Query!
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00377858
Download to PDF