Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Liraglutide

• Registration Number: NCT02089256
• Lead Sponsor: University of Tartu

Brief Summary

The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide, on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may change after repeated administration. The effect of liraglutide on insulin release will be tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be performed without medication and repeated 12 hours after first dose of liraglutide and after 3 weeks of treatment with liraglutide.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Study Start: 2014-06
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Weight 50-100 kg

Exclusion Criteria

• Chronic disease
• Concomitant drug use
• Pregnancy or lactation
• Fasting glucose >6 mmol/L.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liraglutide	Liraglutide	Liraglutide 0.6 mg/day subcutaneously.

Primary Outcome Measures

Name	Time	Method
Change in the glucose-sensitivity of the beta cells	baseline, first dose, after 3-weeks on treatment	Graded glucose infusion test will be used to create insulin secretion rate- plasma glucose curve. The primary outcome is the change of the slope of the curve from baseline after acute administration of liraglutide compared to the repeated administration (after 3-weeks of treatment).

Secondary Outcome Measures

Name	Time	Method
Effects on adrenal hormones	baseline, acute administration, 3 weeks	change in ACTH/cortisol levels and renin / aldosterone levels after acute and repeated administration of liraglutide.

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Estonia