The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: liraglutide (Drug); placebo (Drug); glimepiride (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Jason Brett, MD, Study Director, Affiliation: Novo Nordisk

Overall contact:
Novo Nordisk Clinical Trial Call Center, Phone: 866-867-7178

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

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

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

Primary outcome: ACh-mediated forearm blood flow (FBF)

Secondary outcome:

SNP-mediated FBF

HbA1c

FPG

7-point plasma glucose profiles (self-measured)

Body weight

Fasting lipid profile

Biomarkers of cardiovascular risk

Adverse events

Incidence of hypoglycaemic episodes

Haematology and biochemistry tests

Minimum age: 40 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Novo Nordisk Clinical Trial Call Center, Phone: 866-867-7178

Novo Nordisk Clinical Trial Call Center, Rochester, Minnesota 55905-0001, United States; Recruiting

Clinical Trials at Novo Nordisk

Starting date: February 2008
Ending date: February 2009
Last updated: November 14, 2008