Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

NCT01541215 · Completed

Last updated 2026-05-28

This clinical trial tested whether adding liraglutide to metformin helps manage type 2 diabetes in children and adolescents better than metformin alone.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 135 people

Who can join Ages 10–17 · all sexes

Timeline Started 2012-11 · est. completion 2020-05

Where 185 sites · Australia, 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

What this study is testing ClinicalTrials.gov NCT01541215 ↗

Description as written by the study sponsor.

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.

Treatments tested

liraglutide Drug

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.
placebo Drug

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.
metformin Drug

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.

Main thing measured	Change in HbA1c (Glycosylated Haemoglobin)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01541215 ↗