Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

Official Title: “Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes”

This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes

Intervention(s) in this Clinical Trial

• Drug: liraglutide
  • 0.6 mg/day, s.c. (under the skin) injection
• Drug: placebo
  • Glimepiride placebo, capsules
• Drug: liraglutide
  • 1.2 mg/day, s.c. (under the skin) injection
• Drug: liraglutide
  • 1.8 mg/day, s.c. (under the skin) injection
• Drug: glimepiride
  • Capsules, 4.0 mg/day
• Drug: metformin
  • Tablets, 1.5-2.0 g/day
• Drug: placebo
  • Liraglutide placebo, s.c. (under the skin) injection

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Lira 0.6 + Met
  • Liraglutide 0.6 mg + metformin + glimepiride placebo
• Experimental: Lira 1.2 + Met
  • Liraglutide 1.2 mg + metformin + glimepiride placebo
• Experimental: Lira 1.8 + Met
  • Liraglutide + metformin + glimepiride placebo
• Experimental: Glim + Met
  • Glimepiride 4.0 mg + metformin + liraglutide placebo

Primary Measures

• Change in Glycosylated Haemoglobin A1c (HbA1c)
  • Time Frame: week 0, week 16
    Safety Issue?: No

Secondary Measures

• Change in Body Weight
  • Time Frame: week 0, week 16
    Safety Issue?: No
• Change in Self-measured Fasting Plasma Glucose
  • Time Frame: week 0, week 16
    Safety Issue?: No
• 7-point Self-measured Plasma Glucose Profiles
  • Time Frame: week 0, 8, 12 and 16
    Safety Issue?: No
• Change in Beta-cell Function
  • Time Frame: week 0, week 16
    Safety Issue?: No
• Change in Fasting Lipid Profile
  • Time Frame: week 0, week 16
    Safety Issue?: No
• Change in Fasting Lipid Profile, APO-B
  • Time Frame: week 0, week 16
    Safety Issue?: No
• Hypoglycaemic Episodes
  • Time Frame: weeks 0-16
    Safety Issue?: Yes

Inclusion Criteria:

• Type 2 diabetes
• Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
• HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
• HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
• Body Mass Index (BMI) less than 45.0 kg/m2

Exclusion Criteria:

• Treatment with insulin within the last 3 months prior to the trial
• Impaired liver or/and renal function
• Significant cardiovascular disease over the last 6 months
• Known retinopathy or maculopathy
• Recurrent major hypoglycaemia or hypoglycaemic unawareness

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

Marcin Zychma, MD, PhD Study Director Novo Nordisk  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00614120

Study ID Number: NN2211-1796

ClinicalTrials.gov Identifier: NCT00614120

Health Authority: China: State Food and Drug Administration

Clinical Trials at Novo Nordisk