The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT00620282
- Phase
- PHASE3
- Status
- Completed
Conditions
- Diabetes
- Diabetes Mellitus, Type 2
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- liraglutide — DRUGStepwise dose increase, s.c. (under the skin) injection, once daily
- placebo — DRUGLiraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily
- glimepiride — DRUGTablets, 1 - 4 mg daily
Study Details
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.
Key Dates
- Start date
- Feb 29, 2008
- Status verified
- Jan 2017
- Primary completion
- May 31, 2010
- Completion
- May 31, 2010
Study Design
- Enrollment
- 49 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Lira 1.8Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
- Placebo Comparator: PlaceboPlacebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
- Active Comparator: GlimepirideGlimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
Primary Outcome Measure
Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF) [ Time Frame: week 0, week 12 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Novo Nordisk Investigational Site | Rochester | Minnesota | 55905 | - |
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