Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes (Liratime)
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
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes|
- Change in ambulatory blood pressure [ Time Frame: 50 days ] [ Designated as safety issue: No ]Change in 24h BP from day 1 to day 49 (baseline to end of treatment) and time to statistically significant change in BP 24h after initiation of or increased dose of liraglutide
- Change in ECV [ Time Frame: 50 days ] [ Designated as safety issue: No ]Changes in ECV (measured by GFR), urinary sodium, weight, arterial stiffness and daily home-BP, from day 1 to day 49 (baseline to end of treatment).
- Washout analysis [ Time Frame: 21 ] [ Designated as safety issue: No ]Change in 24h BP, ECV, weight, arterial stiffness from day 49 to day 70th
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
single-group study were participants recieve Liraglutide
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
Other Name: Victoza
Hypotheses Primary hypothesis • Liraglutide treatment causes a reduction in 24h BP
- The effect on BP may be mediated by an increase in natriuresis, thereby affecting ECV
- The effect on BP may be mediated by a decrease in arterial stiffness and central aortic pressure
Purpose Primary purpose
• To assess how quickly the antihypertensive effect of liraglutide treatment set in after initiation in patients with type 2 diabetes
- To measure the effect of liraglutide treatment on natriuresis.
- To measure the effect of liraglutide treatment on ECV
- To measure the effect of liraglutide treatment on arterial stiffness
- To measure weight change after initiation of liraglutide treatment
|Contact: Peter Rossing, MD||+45 firstname.lastname@example.org|
|Contact: Maria Lajer, M.Sc||+45 email@example.com|
|Steno Diabetes Center||Recruiting|
|Gentofte, Denmark, 2820|
|Contact: peter rossing firstname.lastname@example.org|
|Principal Investigator: Peter Rossing, MD|
|Sub-Investigator: Frederik Persson, MD|
|Sub-Investigator: Maria Lajer, MSc|
|Principal Investigator:||Peter Rossing, MD||Steno Diabetes Centes|