Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

Healthy Clinical Trial

Official title:

Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089256
• Other study ID #: LI20/1101
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2014
• Last updated: March 31, 2015
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: State Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Weight 50-100 kg

Exclusion Criteria:

• Chronic disease

• Concomitant drug use

• Pregnancy or lactation

• Fasting glucose >6 mmol/L.

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Liraglutide
Graded glucose infusion test (GGIT)will be performed on baseline. 1 week later treatment with liraglutide 0.6mg/day (injected between 21.00-23.00) will be initiated. GGIT will be repeated 12 hours after first injection and after 21 days on-treatment (12 hours after last injection).

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the glucose-sensitivity of the beta cells	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).	baseline, first dose, after 3-weeks on treatment	No
Secondary	Effects on adrenal hormones	change in ACTH/cortisol levels and renin / aldosterone levels after acute and repeated administration of liraglutide.	baseline, acute administration, 3 weeks	No