Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

NCT ID: NCT02089256

Last Updated: 2015-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide

Liraglutide 0.6 mg/day subcutaneously.

Group Type EXPERIMENTAL

Liraglutide

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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Victoza

Eligibility Criteria

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Inclusion Criteria

* Weight 50-100 kg

Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tartu

OTHER

Sponsor Role lead

Responsible Party

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Vallo Volke

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vallo Volke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Locations

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Tartu University Hospital

Tartu, , Estonia

Site Status

Countries

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Estonia

References

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Heinla K, Vasar E, Reppo I, Sedman T, Volke V. GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers. Diabetes Ther. 2023 Apr;14(4):777-786. doi: 10.1007/s13300-023-01381-w. Epub 2023 Feb 17.

Reference Type DERIVED
PMID: 36800161 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28379427 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27300475 (View on PubMed)

Other Identifiers

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LI20/1101

Identifier Type: -

Identifier Source: org_study_id

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