Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes

Sponsor
Peter Rossing
Study ID
NCT01499108
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Subcutaneous injection of liraglutide at doses of 0.6, 1.2, and 1.8 mg once daily during the 49 days duration of the study

Study Details

Background: Preclinical blood pressure (BP) data from studies of hypoglycemic effects of liraglutide treatment (the LEAD program), revealed a significant antihypertensive potential. The time course and the mechanism behind this effect are unknown. Objectives: To evaluate the time course of the antihypertensive effect of liraglutide treatment in patients with type 2 diabetes Design: Open-label study with intervention and subsequent washout period Patient Population: 35 hypertensive (SBP ≥130 mm Hg and DBP ≥80 mmHg) patients with type 2 diabetes. Intervention: All patients will be treated with liraglutide 0.6 mg once daily for 7 days and will then be titrated to 1.2 mg once daily for 14 days and then titrated to 1.8 mg once daily for 4 weeks. This is followed by a washout period of 3 weeks without liraglutide treatment. Endpoints: 24-hour blood pressure, natriuresis, extra cellular volume (ECV

Key Dates

Start date
Aug 31, 2012
Status verified
Jul 2013
Primary completion
Jul 31, 2013
Completion
Aug 31, 2014

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
    single-group study were participants recieve Liraglutide

Primary Outcome Measure

Change in ambulatory blood pressure [ Time Frame: 50 days ]

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