CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 135 enrolled
Drug / intervention
liraglutide +2 moredrug
Likely dose
liraglutide 1.8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01541215
NCT01541215Phase 3Completed
CompareCT.gov

Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Feb 29, 2012·Updated Jul 2, 2021

In Brief

A Phase 3 clinical trial evaluating liraglutide, placebo, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 135 participants across 185 sites in 36 countries.

Detailed Summary

This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAustralia, Austria, Belgium, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 29, 2012
Enrollment StartNov 13, 2012
Primary CompletionNov 15, 2017
Study CompletionMay 20, 2020
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 14.3 years ago

Interventions

liraglutidedrug

Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.

placebodrug

Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.

metformindrug

Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.