Official Title: “The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus”

This trial is conducted in the United States of America (USA). The purpose of the trial is to assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who are on diet and lifestyle changes or treated with metformin alone

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: liraglutide
  • Stepwise dose increase, s.c. injection, once daily
• Drug: placebo
  • Liraglutide placebo, stepwise dose increase, s.c. injection, once daily
• Drug: glimepiride
  • Tablets, 1 - 4 mg daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Active Comparator: C

Primary Measures

• ACh-mediated forearm blood flow (FBF)
  • Time Frame: after 12 weeks of treatment
    Safety Issue?: No

Secondary Measures

• SNP-mediated FBF
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• HbA1c
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• FPG
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• 7-point plasma glucose profiles (self-measured)
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Body weight
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Fasting lipid profile
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Biomarkers of cardiovascular risk
  • Time Frame: For the duration of the trial
    Safety Issue?: Yes
• Adverse events
  • Time Frame: For the duration of the trial
    Safety Issue?: Yes
• Incidence of hypoglycaemic episodes
  • Time Frame: For the duration of the trial
    Safety Issue?: Yes
• Haematology and biochemistry tests
  • Time Frame: For the duration of the trial
    Safety Issue?: No

Inclusion Criteria:

• Type 2 diabetes
• Diet and lifestyle changes or metformin monotherapy for at least three months
• HbA1c 6.5-9.0% (both inclusive)
• BMI less than or equal to 40 kg/m2

Exclusion Criteria:

• Previous treatment with insulin (except for short term treatment with insulin in connection with intercurrent illness, at the discretion of the Investigator
• Previous treatment with GLP-1 analogues/mimetics, including treatment in a clinical trial
• Treatment with any oral hypoglycaemic agents other than metformin in a period of 3 months prior to screening
• Current smoker or history of smoking within 6 months prior to screening
• Evidence of overt cardiovascular disease (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease)
• Abnormal, clinically significant exercise stress ECG test, as judged by the Investigator
• Known retinopathy or maculopathy requiring acute treatment, as judged by the Investigator
• Known autonomic neuropathy, as judged by the Investigator
• Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering or lipid-lowering medication within 4 weeks prior to screening
• Systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equal to 90 mmHg

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novo Nordisk

Overall Clinical Trial Officials and Contacts

Jason Brett, MD Study Director Novo Nordisk  

Overall Contact: Novo Nordisk Clinical Trial Call Center 866-867-7178 

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620282

Study ID Number: NN2211-1799

ClinicalTrials.gov Identifier: NCT00620282

Health Authority: United States: Institutional Review Board

Clinical Trials at Novo Nordisk