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Completed

NCT Number: NCT02089256

Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tartu University Hospital

Tartu, Estonia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Weight 50-100 kg

Exclusion criteria

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

Treatment and study plan

liraglutide

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2014
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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