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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00318461
Registration number
NCT00318461
Ethics application status
Date submitted
25/04/2006
Date registered
26/04/2006
Date last updated
7/03/2017
Titles & IDs
Public title
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Query!
Scientific title
Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes
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Secondary ID [1]
0
0
NN2211-1572
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Universal Trial Number (UTN)
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Trial acronym
LEAD-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
0
0
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Diabetes Mellitus, Type 2
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0
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Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
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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 - liraglutide
Treatment: Drugs - metformin
Treatment: Drugs - glimepiride
Treatment: Drugs - placebo
Treatment: Drugs - placebo
Treatment: Drugs - liraglutide
Treatment: Drugs - liraglutide
Experimental: Lira 0.6 + Met - Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Experimental: Lira 1.2 + Met - Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Experimental: Lira 1.8 + Met - Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Active comparator: Met Mono - Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo
Active comparator: Met + Glim - Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
Treatment: Drugs: liraglutide
0.6 mg for s.c. (under the skin) injection.
Treatment: Drugs: metformin
1.5-2.0 g tablets
Treatment: Drugs: glimepiride
4 mg tablets
Treatment: Drugs: placebo
Glimepiride placebo 1 mg and 2 mg tablets
Treatment: Drugs: placebo
Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
Treatment: Drugs: liraglutide
1.2 mg for s.c. (under the skin) injection
Treatment: Drugs: liraglutide
1.8 mg for s.c. (under the skin) injection
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Intervention code [1]
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0
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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Change in Glycosylated A1c (HbA1c) at Week 26
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Assessment method [1]
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Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
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Timepoint [1]
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0
week 0, week 26
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Primary outcome [2]
0
0
Change in Glycosylated A1c (HbA1c) at Week 104
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Assessment method [2]
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0
Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)
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Timepoint [2]
0
0
week 0, week 104
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Secondary outcome [1]
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Change in Body Weight at Week 26
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Assessment method [1]
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0
Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)
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Timepoint [1]
0
0
week 0, week 26
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Secondary outcome [2]
0
0
Change in Body Weight at Week 104
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Assessment method [2]
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0
Change in body weight from baseline (week 0) to 104 weeks (end of treatment)
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Timepoint [2]
0
0
week 0, week 104
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Secondary outcome [3]
0
0
Change in Fasting Plasma Glucose (FPG) at Week 26
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Assessment method [3]
0
0
Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)
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Timepoint [3]
0
0
week 0, week 26
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Secondary outcome [4]
0
0
Change in Fasting Plasma Glucose (FPG) at Week 104
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Assessment method [4]
0
0
Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)
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Timepoint [4]
0
0
week 0, week 104
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Secondary outcome [5]
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0
Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
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Assessment method [5]
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Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.
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Timepoint [5]
0
0
week 0, week 26
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Secondary outcome [6]
0
0
Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
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Assessment method [6]
0
0
Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.
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Timepoint [6]
0
0
week 0, week 104
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Secondary outcome [7]
0
0
Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
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Assessment method [7]
0
0
Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.
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Timepoint [7]
0
0
week 0, week 26
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Secondary outcome [8]
0
0
Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
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Assessment method [8]
0
0
Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.
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Timepoint [8]
0
0
week 0, week 104
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Secondary outcome [9]
0
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Change in Beta-cell Function at Week 26
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Assessment method [9]
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Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20·fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5).
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Timepoint [9]
0
0
week 0, week 26
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Secondary outcome [10]
0
0
Change in Beta-cell Function at Week 104
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Assessment method [10]
0
0
Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20·fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5).
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Timepoint [10]
0
0
week 0, week 104
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Secondary outcome [11]
0
0
Hypoglycaemic Episodes at Week 26
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Assessment method [11]
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0
Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
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Timepoint [11]
0
0
weeks 0-26
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Secondary outcome [12]
0
0
Hypoglycaemic Episodes at Week 104
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Assessment method [12]
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0
Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
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Timepoint [12]
0
0
weeks 0-104
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Eligibility
Key inclusion criteria
* Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
* HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
* Body Mass Index (BMI) less than or equal 40 kg/m2
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subjects treated with insulin within the last three months
* Subjects with any serious medical condition
* Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
* Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2008
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Sample size
Target
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Accrual to date
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Final
1091
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Broadmeadow
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Recruitment hospital [2]
0
0
Novo Nordisk Investigational Site - Penrith
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Recruitment hospital [3]
0
0
Novo Nordisk Investigational Site - St Leonards
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Recruitment hospital [4]
0
0
Novo Nordisk Investigational Site - Daw Park
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Recruitment hospital [5]
0
0
Novo Nordisk Investigational Site - East Ringwood
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Recruitment hospital [6]
0
0
Novo Nordisk Investigational Site - Fremantle
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Recruitment hospital [7]
0
0
Novo Nordisk Investigational Site - Adelaide
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Recruitment hospital [8]
0
0
Novo Nordisk Investigational Site - Auckland
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Recruitment hospital [9]
0
0
Novo Nordisk Investigational Site - Bankstown
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Recruitment hospital [10]
0
0
Novo Nordisk Investigational Site - Box Hill
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Recruitment hospital [11]
0
0
Novo Nordisk Investigational Site - Cairns
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Recruitment hospital [12]
0
0
Novo Nordisk Investigational Site - Camperdown
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Recruitment hospital [13]
0
0
Novo Nordisk Investigational Site - Christchurch
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Recruitment hospital [14]
0
0
Novo Nordisk Investigational Site - Clayton
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Recruitment hospital [15]
0
0
Novo Nordisk Investigational Site - Fitzroy
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Recruitment hospital [16]
0
0
Novo Nordisk Investigational Site - Garran
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Recruitment hospital [17]
0
0
Novo Nordisk Investigational Site - Hornsby
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Recruitment hospital [18]
0
0
Novo Nordisk Investigational Site - Malvern
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Recruitment hospital [19]
0
0
Novo Nordisk Investigational Site - Perth
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Recruitment hospital [20]
0
0
Novo Nordisk Investigational Site - Westmead
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Recruitment hospital [21]
0
0
Novo Nordisk Investigational Site - Woodville
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Recruitment postcode(s) [1]
0
0
2292 - Broadmeadow
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Recruitment postcode(s) [2]
0
0
2751 - Penrith
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Recruitment postcode(s) [3]
0
0
2065 - St Leonards
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Recruitment postcode(s) [4]
0
0
5041 - Daw Park
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Recruitment postcode(s) [5]
0
0
3135 - East Ringwood
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Recruitment postcode(s) [6]
0
0
6160 - Fremantle
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Recruitment postcode(s) [7]
0
0
5000 - Adelaide
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Recruitment postcode(s) [8]
0
0
SA 5035 - Adelaide
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Recruitment postcode(s) [9]
0
0
- Auckland
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Recruitment postcode(s) [10]
0
0
2200 - Bankstown
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Recruitment postcode(s) [11]
0
0
3128 - Box Hill
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Recruitment postcode(s) [12]
0
0
4870 - Cairns
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Recruitment postcode(s) [13]
0
0
2050 - Camperdown
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Recruitment postcode(s) [14]
0
0
8011 - Christchurch
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Recruitment postcode(s) [15]
0
0
3168 - Clayton
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Recruitment postcode(s) [16]
0
0
3065 - Fitzroy
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Recruitment postcode(s) [17]
0
0
2605 - Garran
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Recruitment postcode(s) [18]
0
0
2077 - Hornsby
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Recruitment postcode(s) [19]
0
0
3144 - Malvern
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Recruitment postcode(s) [20]
0
0
6000 - Perth
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Recruitment postcode(s) [21]
0
0
2145 - Westmead
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Recruitment postcode(s) [22]
0
0
5011 - Woodville
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Recruitment outside Australia
Country [1]
0
0
Argentina
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State/province [1]
0
0
Ciudad Autonoma de Bs As
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Country [2]
0
0
Argentina
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State/province [2]
0
0
Ciudad Autónoma de Bs As
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Country [3]
0
0
Argentina
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State/province [3]
0
0
Ciudad Autónoma de BsAs
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Country [4]
0
0
Argentina
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State/province [4]
0
0
Junín
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Country [5]
0
0
Belgium
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State/province [5]
0
0
Arlon
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Bonheiden
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Gent
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Huy
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Country [9]
0
0
Belgium
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State/province [9]
0
0
La Louvière
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Country [10]
0
0
Belgium
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State/province [10]
0
0
Leuven
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Country [11]
0
0
Bulgaria
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State/province [11]
0
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Sofia
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Country [12]
0
0
Croatia
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State/province [12]
0
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Zagreb
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Country [13]
0
0
Denmark
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State/province [13]
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Aalborg
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Country [14]
0
0
Denmark
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State/province [14]
0
0
Frederiksberg
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Country [15]
0
0
Denmark
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State/province [15]
0
0
Herlev
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Country [16]
0
0
Denmark
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State/province [16]
0
0
Hjørring
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Country [17]
0
0
Denmark
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State/province [17]
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Hvidovre
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0
0
Denmark
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State/province [18]
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København S
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0
Denmark
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State/province [19]
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København
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0
0
Denmark
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State/province [20]
0
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Odense
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Country [21]
0
0
Denmark
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State/province [21]
0
0
Viborg
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Country [22]
0
0
Denmark
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State/province [22]
0
0
Århus C
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Country [23]
0
0
Germany
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State/province [23]
0
0
Aschaffenburg
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Country [24]
0
0
Germany
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State/province [24]
0
0
Bad Heilbrunn
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Country [25]
0
0
Germany
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State/province [25]
0
0
Bad Kreuznach
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Country [26]
0
0
Germany
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State/province [26]
0
0
Bad Lauterberg
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Country [27]
0
0
Germany
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State/province [27]
0
0
Bad Mergentheim
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Country [28]
0
0
Germany
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State/province [28]
0
0
Bad Neuenahr-Ahrweiler
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0
0
Germany
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0
0
Beckum
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Country [30]
0
0
Germany
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0
0
Bensheim
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0
0
Germany
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0
0
Berlin
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Country [32]
0
0
Germany
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0
0
Darmstadt
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0
0
Germany
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0
0
Diez
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0
0
Germany
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0
0
Dormagen
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0
0
Germany
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0
0
Dresden
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0
0
Germany
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State/province [36]
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0
Flensburg
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0
0
Germany
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State/province [37]
0
0
Großheirath
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Country [38]
0
0
Germany
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State/province [38]
0
0
Halle
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Country [39]
0
0
Germany
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State/province [39]
0
0
Hamburg
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Country [40]
0
0
Germany
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State/province [40]
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0
Kutenholz-Mulsum
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Country [41]
0
0
Germany
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State/province [41]
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0
Köln
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Country [42]
0
0
Germany
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State/province [42]
0
0
Ludwigshafen
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0
0
Germany
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0
0
Marburg
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0
0
Germany
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0
0
Münster
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0
0
Germany
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State/province [45]
0
0
Neuwied
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0
0
Germany
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0
0
Oberhausen
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0
0
Germany
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State/province [47]
0
0
Pirna
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Country [48]
0
0
Germany
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0
0
Pohlheim
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0
0
Germany
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State/province [49]
0
0
Regensburg
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0
0
Germany
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State/province [50]
0
0
Rehlingen-Siersburg
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Country [51]
0
0
Germany
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State/province [51]
0
0
Saaldorf-Surheim
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0
0
Germany
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State/province [52]
0
0
Saarbrücken
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Country [53]
0
0
Germany
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State/province [53]
0
0
Speyer
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Country [54]
0
0
Germany
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State/province [54]
0
0
St. Ingbert
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0
0
Germany
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0
0
Stuttgart
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0
0
Germany
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0
Sulzbach-Rosenberg
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0
0
Germany
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0
0
Tübingen
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0
0
Germany
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0
0
Viersen
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0
0
Germany
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0
0
Völklingen
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0
0
Germany
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0
0
Würzburg
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0
0
Hungary
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0
0
Budapest
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Country [62]
0
0
Hungary
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State/province [62]
0
0
Debrecen
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Country [63]
0
0
Hungary
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State/province [63]
0
0
Gyula
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Country [64]
0
0
Hungary
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State/province [64]
0
0
Nyíregyháza
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Country [65]
0
0
Hungary
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State/province [65]
0
0
Pecs
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Country [66]
0
0
Hungary
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State/province [66]
0
0
Szekszárd
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Country [67]
0
0
Hungary
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State/province [67]
0
0
Zalaegerszeg
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0
0
India
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State/province [68]
0
0
Andhra Pradesh
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Country [69]
0
0
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Funding & Sponsors
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Summary
Brief summary
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).
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Trial website
https://clinicaltrials.gov/study/NCT00318461
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Trial related presentations / publications
Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17. Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12. Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997. McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998. Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x. Jendle J, Nauck MA, Matthews DR, Frid A, Hermansen K, During M, Zdravkovic M, Strauss BJ, Garber AJ; LEAD-2 and LEAD-3 Study Groups. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009 Dec;11(12):1163-72. doi: 10.1111/j.1463-1326.2009.01158.x. Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30. Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4. Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906. Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30. Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x. Nauck M, Frid A, Hermansen K, Thomsen AB, During M, Shah N, Tankova T, Mitha I, Matthews DR. Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. Diabetes Obes Metab. 2013 Mar;15(3):204-12. doi: 10.1111/dom.12012. Epub 2012 Oct 11. Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9. Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23. King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR. Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622. doi: 10.2337/dc15-er08. Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21. Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.
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Public notes
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Contacts
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Global Clinical Registry (GCR, 1452)
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Novo Nordisk A/S
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No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, ...
[
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]
Journal
Sullivan SD, Alfonso-Cristancho R, Conner C, Hamme...
[
More Details
]
Journal
Nauck M, Marre M. Adding liraglutide to oral antid...
[
More Details
]
Journal
McGill JB. Insights from the Liraglutide Clinical ...
[
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]
Journal
Blonde L, Russell-Jones D. The safety and efficacy...
[
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]
Journal
Jendle J, Nauck MA, Matthews DR, Frid A, Hermansen...
[
More Details
]
Journal
Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett...
[
More Details
]
Journal
Bode BW, Brett J, Falahati A, Pratley RE. Comparis...
[
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]
Journal
Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, ...
[
More Details
]
Journal
Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Ac...
[
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]
Journal
Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-...
[
More Details
]
Journal
Nauck M, Frid A, Hermansen K, Thomsen AB, During M...
[
More Details
]
Journal
Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft ...
[
More Details
]
Journal
Alves C, Batel-Marques F, Macedo AF. A meta-analys...
[
More Details
]
Journal
King AB, Montanya E, Pratley RE, Blonde L, Svendse...
[
More Details
]
Journal
Jensen TM, Saha K, Steinberg WM. Is there a link b...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00318461
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