Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

March 31, 2015 updated by: Vallo Volke, University of Tartu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tartu, Estonia
        • Tartu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weight 50-100 kg

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide
Liraglutide 0.6 mg/day subcutaneously.
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).

Other Names:
  • Victoza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the glucose-sensitivity of the beta cells
Time Frame: 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).
baseline, first dose, after 3-weeks on treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on adrenal hormones
Time Frame: baseline, acute administration, 3 weeks
change in ACTH/cortisol levels and renin / aldosterone levels after acute and repeated administration of liraglutide.
baseline, acute administration, 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tartu

Investigators

  • Principal Investigator: Vallo Volke, MD, Tartu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 17, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LI20/1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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