Blood Pressure Outcomes With Liraglutide Therapy

Sponsor
Mount Sinai Hospital, Canada
Study ID
NCT01755572
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Liraglutide — DRUG
    Single cross-over study, 1 arm starting with liraglutide for 3 weeks crossed-over to placebo for 3 weeks, and 1 arm starting with placebo with cross-over to liraglutide for 3 weeks.
  • Placebo — DRUG
    Single cross-over study, 1 arm starting with liraglutide for 3 weeks crossed-over to placebo for 3 weeks, and 1 arm starting with placebo with cross-over to liraglutide for 3 weeks.

Study Details

Purpose: The purpose of this study is to further study the mechanism by which liraglutide, a relatively new anti-hyperglycemic medication, might lower blood pressure in patients with Type 2 diabetes and high blood pressure.

Key Dates

Start date
Jan 31, 2013
Status verified
Mar 2015
Primary completion
Jan 31, 2014
Completion
Mar 31, 2014

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Liraglutide
    Liraglutide 0.6mg for 7 days, liraglutide 1.2mg for 7 days, liraglutide 1.8mg for 7 days
  • Placebo Comparator: Placebo
    Placebo 0.6mg sc for 3 weeks, Placebo 1.2mg sc for 3 weeks, Placebo 1.8mg for 3 weeks.

Primary Outcome Measure

Change in plasma ANP level at 1 Day [ Time Frame: Change from Baseline compared in plasma ANP following 1 dose of liraglutide (0.6 mg) compared to crossover treatment with placebo at the 2-hour timepoint ]

Related Studies