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

Official Title: “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).

Intervention(s) in this Clinical Trial

• 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: glimepiride
  • 8 mg capsule
• Drug: placebo
  • Glimepiride placebo, 8mg capsule
• Drug: placebo
  • Liraglutide placebo, 200 mcl
• Drug: placebo
  • Liraglutide placebo, 300 mcl

Arms, Groups and Cohorts in this Clinical Trial

• 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).
• 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).
• 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).
• 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).

Primary Measures

• Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
  • Time Frame: week 0, week 52
    Safety Issue?: No
• Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104
  • Time Frame: week 0, week 104
    Safety Issue?: No
• Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156
  • Time Frame: week 0, week 156
    Safety Issue?: No

Secondary Measures

• Change in Body Weight at Week 52
  • Time Frame: week 0, week 52
    Safety Issue?: No
• Change in Body Weight at Week 104
  • Time Frame: week 0, week 104
    Safety Issue?: No
• Change in Body Weight at Week 156
  • Time Frame: week 0, week 156
    Safety Issue?: No
• Change in Fasting Plasma Glucose at Week 52
  • Time Frame: week 0, week 52
    Safety Issue?: No
• Change in Fasting Plasma Glucose at Week 104
  • Time Frame: week 0, week 104
    Safety Issue?: No
• Change in Fasting Plasma Glucose at Week 156
  • Time Frame: week 0, week 156
    Safety Issue?: No
• Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
  • Time Frame: week 0, week 52
    Safety Issue?: No
• Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
  • Time Frame: week 0, week 104
    Safety Issue?: No
• Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
  • Time Frame: week 0, week 156
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Hypoglycaemic Episodes
  • Time Frame: weeks 0-104
    Safety Issue?: Yes
• Hypoglycaemic Episodes
  • Time Frame: weeks 104-195
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novo Nordisk Industry

Overall Clinical Trial Officials and Contacts

Paula Hale, MD Study Director Novo Nordisk  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00294723

Study ID Number: NN2211-1573

ClinicalTrials.gov Identifier: NCT00294723

Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Clinical Trials at Novo Nordisk