Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes (Liratime)
|ClinicalTrials.gov Identifier: NCT01499108|
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : February 2, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: liraglutide||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||August 2014|
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
- Change in ambulatory blood pressure [ Time Frame: 50 days ]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 ]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 ]Change in 24h BP, ECV, weight, arterial stiffness from day 49 to day 70th
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499108
|Steno Diabetes Center|
|Gentofte, Denmark, 2820|
|Principal Investigator:||Peter Rossing, MD||Steno Diabetes Centes|