Type 2 Diabetes Clinical Trial
Official title:
Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes
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
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
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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