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CompletedNCT02089256Updated Apr 1, 2015

Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

A Phase 4 interventional study of Liraglutide in Healthy, sponsored by University of Tartu. Completed at 1 site in Estonia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-01.

Sponsored by University of Tartu · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
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Study 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.

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Conditions studied

  • Healthy
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In context

Lead sponsor

University of Tartu is the lead sponsor of 45 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Weight 50-100 kg

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Liraglutide

    Liraglutide 0.6 mg/day subcutaneously.

    Drug: 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).

    Also known as: Victoza

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: baseline, first dose, after 3-weeks on treatment

Secondary outcomes

  1. Effects on adrenal hormones

    change in ACTH/cortisol levels and renin / aldosterone levels after acute and repeated administration of liraglutide.

    Time frame: baseline, acute administration, 3 weeks

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Study locations

1 site
  • Tartu University Hospital
    Tartu, Estonia
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References and documents

Publications

  • Sedman T, Vasar E, Volke V. Tolerance Does Not Develop Toward Liraglutide's Glucose-Lowering Effect. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2335-2339. doi: 10.1210/jc.2017-00199. PubMed 28379427 ↗
  • Sedman T, Heinla K, Vasar E, Volke V. Liraglutide Treatment May Affect Renin and Aldosterone Release. Horm Metab Res. 2017 Jan;49(1):5-9. doi: 10.1055/s-0042-109065. Epub 2016 Jun 14. PubMed 27300475 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02089256
Lead sponsor
University of Tartu
Responsible party
Vallo Volke (Professor, University of Tartu) — Principal investigator
First posted
Mar 17, 2014
Start date
Jun 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Apr 1, 2015

Study contacts

Vallo Volke, MD
principal investigator · Tartu University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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