Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

NCT02089256 | Completed Phase 4

• 1 other identifier: LI20/1101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

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).

  baseline, first dose, after 3-weeks on treatment

Secondary Outcomes (1)

• Effects on adrenal hormones

  baseline, acute administration, 3 weeks

Study Arms (1)

Liraglutide

EXPERIMENTAL

Liraglutide 0.6 mg/day subcutaneously.

Drug: Liraglutide

Interventions

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).

Also known as: Victoza

Liraglutide

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Weight 50-100 kg

You may not qualify if:

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

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (1)

Tartu University Hospital

Tartu, Estonia

Location

Related Publications (3)

• 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.

  PMID: 36800161 DERIVED

• 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.

  PMID: 28379427 DERIVED

• 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.

  PMID: 27300475 DERIVED

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Vallo Volke, MD

  University of Tartu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

ES (1)