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Clinical Trial 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


Clinical Trial 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 ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01499108
Study type Interventional
Source Steno Diabetes Center
Contact
Status Completed
Phase Phase 4
Start date August 2012
Completion date August 2014

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