Effect of repeated administration of liraglutide on insulinogenic indices.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000238-43-EE

Enrollment

Registered

2014-03-17

Start date

2014-05-13

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Healthy volunteers (Type 2. diabetes mellitus). MedDRA version: 17.0 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 100000004860

Interventions

Trade Name: Victoza Product Name: Liraglutide (Victoza) Pharmaceutical Form: Solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 18-50 years 2) Bodyweight 50-100 kg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Existence of chronic diseases 2) Existence of drugs used daily 3) Pregnancy, lactation 4) Glucose plasma level (fasting state) =6,0 mmol/L

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to compare the insulinogenic effect of liraglutide after acute and chronic (21 days) administration.;Secondary Objective: Secondary objective of the trial is to investigate the effects of liraglutide on adrenal hormones.;Primary end point(s): 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 end-point 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). ISR is calculated using C-peptide levels.;Timepoint(s) of evaluation of this end point: baseline, after 1st dose of liraglutide , after 21 days treatment with liraglutide.	—

Measure

Time frame

Main Objective: The main objective of the trial is to compare the insulinogenic effect of liraglutide after acute and chronic (21 days) administration.;Secondary Objective: Secondary objective of the trial is to investigate the effects of liraglutide on adrenal hormones.;Primary end point(s): 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 end-point 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). ISR is calculated using C-peptide levels.;Timepoint(s) of evaluation of this end point: baseline, after 1st dose of liraglutide , after 21 days treatment with liraglutide.

—

Secondary

Measure	Time frame
Secondary end point(s): Other indicators for insulin secretion and hormonal parameters (renin, aldosterone, ACTH, cortisol) which are compared in acute and chronic liraglutide administration setting. ;Timepoint(s) of evaluation of this end point: Same as timepoints of evaluation of primary endpoints.	—

Countries

Estonia

Contacts

Public ContactDepartment of Physiology

University of Tartu

vallo.volke@ut.ee

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026