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

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Stepwise dose increase, s.c. (under the skin) injection, once daily
  • placebo — DRUG
    Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily
  • glimepiride — DRUG
    Tablets, 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 1.8
    Liraglutide 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: Placebo
    Placebo 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: Glimepiride
    Glimepiride 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)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteRochesterMinnesota55905-

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