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Trial record 4 of 401 for:    LIRAGLUTIDE

Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089256
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Vallo Volke, University of Tartu

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Liraglutide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Repeated Administration of Liraglutide on Insulinogenic Indices
Study Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide
Liraglutide 0.6 mg/day subcutaneously.
Drug: 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).

Other Name: Victoza




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Weight 50-100 kg

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089256


Locations
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Estonia
Tartu University Hospital
Tartu, Estonia
Sponsors and Collaborators
University of Tartu
Investigators
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Principal Investigator: Vallo Volke, MD Tartu University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vallo Volke, Professor, University of Tartu
ClinicalTrials.gov Identifier: NCT02089256    
Other Study ID Numbers: LI20/1101
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists