NCT01499108

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Peter Rossing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Hypotheses Primary hypothesis • Liraglutide treatment causes a reduction in 24h BP Secondary hypothesis: * 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 Secondary objectives * 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

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-07-01
• Completion: 2014-08-01
• First posted: 2011-12-26
• Last updated: 2015-02-02

Locations

1 site across 1 country: Denmark