Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes (Liratime)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|