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Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02089256
Enrollment
10
Registered
2014-03-17
Start date
2014-06-30
Completion date
2015-03-31
Last updated
2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLiraglutide

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).

Sponsors

University of Tartu
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Weight 50-100 kg

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the glucose-sensitivity of the beta cellsbaseline, first dose, after 3-weeks on treatmentGraded 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

MeasureTime frameDescription
Effects on adrenal hormonesbaseline, acute administration, 3 weekschange in ACTH/cortisol levels and renin / aldosterone levels after acute and repeated administration of liraglutide.

Countries

Estonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026