To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c (LEAD-3)

This study has been terminated.
(The trial was terminated at week 195 due to an insufficient number of subjects remaining to obtain reasonable statistical power)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00294723
First received: February 20, 2006
Last updated: June 25, 2014
Last verified: June 2014

February 20, 2006
June 25, 2014
February 2006
November 2008   (final data collection date for primary outcome measure)
  • Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
    Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)
  • Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
    Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)
  • Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 [ Time Frame: week 0, week 156 ] [ Designated as safety issue: No ]
    Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks
- Change in HbA1c after 52 weeks
Complete list of historical versions of study NCT00294723 on ClinicalTrials.gov Archive Site
  • Change in Body Weight at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
    Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)
  • Change in Body Weight at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
    Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)
  • Change in Body Weight at Week 156 [ Time Frame: week 0, week 156 ] [ Designated as safety issue: No ]
    Change in body weight from baseline (week 0) to 156 weeks
  • Change in Fasting Plasma Glucose at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)
  • Change in Fasting Plasma Glucose at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)
  • Change in Fasting Plasma Glucose at Week 156 [ Time Frame: week 0, week 156 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks
  • Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
    Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
  • Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
    Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
  • Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156 [ Time Frame: week 0, week 156 ] [ Designated as safety issue: No ]
    Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
  • Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
    Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
  • Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
    Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
  • Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156 [ Time Frame: week 0, week 156 ] [ Designated as safety issue: No ]
    Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
  • Hypoglycaemic Episodes [ Time Frame: weeks 0-104 ] [ Designated as safety issue: Yes ]
    Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
  • Hypoglycaemic Episodes [ Time Frame: weeks 104-195 ] [ Designated as safety issue: Yes ]
    Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
  • - Body Weight
  • - Glycemic Control
  • - Safety and Tolerability
Not Provided
Not Provided
 
To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c
Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes

This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: liraglutide
    1.8 mg for s.c. (under the skin) injection
  • Drug: glimepiride
    8 mg capsule
  • Drug: liraglutide
    1.2 mg for s.c. (under the skin) injection
  • Drug: placebo
    Glimepiride placebo, 8mg capsule
  • Drug: placebo
    Liraglutide placebo, 200 mcl
  • Drug: placebo
    Liraglutide placebo, 300 mcl
  • Experimental: Lira 1.8
    Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
  • Experimental: Lira 1.2
    Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
  • Active Comparator: Glimepiride - 1
    Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
    Interventions:
    • Drug: glimepiride
    • Drug: placebo
  • Active Comparator: Glimepiride - 2
    Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
    Interventions:
    • Drug: glimepiride
    • Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
746
March 2010
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months
  • Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive
  • OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive
  • Body Mass Index (BMI) less than or equal to 45 kg/m^2

Exclusion Criteria:

  • Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness
  • Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
  • Any serious medical condition
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico,   United States,   Puerto Rico
 
NCT00294723
NN2211-1573
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP