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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00294723
Recruitment Status : Terminated (The trial was terminated at week 195 due to an insufficient number of subjects remaining to obtain reasonable statistical power)
First Posted : February 22, 2006
Results First Posted : March 12, 2010
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: glimepiride Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 746 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes
Study Start Date : February 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C

Arms and Interventions
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Arm Intervention/treatment
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).
 Drug: liraglutide
1.8 mg for s.c. (under the skin) injection

Drug: placebo
Glimepiride placebo, 8mg capsule
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).
 Drug: liraglutide
1.2 mg for s.c. (under the skin) injection

Drug: placebo
Glimepiride placebo, 8mg capsule
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).
 Drug: glimepiride
8 mg capsule

Drug: placebo
Liraglutide placebo, 200 mcl
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).
 Drug: glimepiride
8 mg capsule

Drug: placebo
Liraglutide placebo, 300 mcl


Outcome Measures
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Primary Outcome Measures :
  1. Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 [ Time Frame: week 0, week 52 ]
    Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)

  2. Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 [ Time Frame: week 0, week 104 ]
    Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)

  3. Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 [ Time Frame: week 0, week 156 ]
    Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks


Secondary Outcome Measures :
  1. Change in Body Weight at Week 52 [ Time Frame: week 0, week 52 ]
    Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)

  2. Change in Body Weight at Week 104 [ Time Frame: week 0, week 104 ]
    Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)

  3. Change in Body Weight at Week 156 [ Time Frame: week 0, week 156 ]
    Change in body weight from baseline (week 0) to 156 weeks

  4. Change in Fasting Plasma Glucose at Week 52 [ Time Frame: week 0, week 52 ]
    Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)

  5. Change in Fasting Plasma Glucose at Week 104 [ Time Frame: week 0, week 104 ]
    Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)

  6. Change in Fasting Plasma Glucose at Week 156 [ Time Frame: week 0, week 156 ]
    Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks

  7. Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52 [ Time Frame: week 0, week 52 ]
    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.

  8. Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104 [ Time Frame: week 0, week 104 ]
    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.

  9. Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156 [ Time Frame: week 0, week 156 ]
    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.

  10. 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 ]
    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.

  11. 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 ]
    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.

  12. 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 ]
    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.

  13. Hypoglycaemic Episodes [ Time Frame: weeks 0-104 ]
    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.

  14. Hypoglycaemic Episodes [ Time Frame: weeks 104-195 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294723


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00294723    
Obsolete Identifiers: NCT00853359
Other Study ID Numbers: NN2211-1573
First Posted: February 22, 2006    Key Record Dates
Results First Posted: March 12, 2010
Last Update Posted: March 7, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Glimepiride
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors