Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

135

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Nov 2012

Longer than P75 for phase_3 diabetes

Geographic Reach

33 countries

177 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.5 years study duration

First Submitted

Initial submission to the registry

February 23, 2012

Completed

6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed

9 months until next milestone

Study Start

First participant enrolled

November 13, 2012

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 11, 2018

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed

Last Updated

July 2, 2021

Status Verified

July 1, 2021

Enrollment Period

5 years

First QC Date

February 23, 2012

Results QC Date

November 15, 2018

Last Update Submit

July 1, 2021

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Glycosylated Haemoglobin)
Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Week 0, week 26

Secondary Outcomes (79)

Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 26
Number of Subjects Having HbA1c Below 7.0%
Week 26
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
Week 0, week 26
Number of Subjects Having HbA1c Below 7.0%
Week 52
Number of Subjects Having HbA1c Maximum 6.5%
Week 26
+74 more secondary outcomes

Study Arms (2)

Lira + Met

EXPERIMENTAL

Drug: liraglutideDrug: metformin

Placebo + Met

PLACEBO COMPARATOR

Drug: placeboDrug: metformin

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.

Lira + 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.

Placebo + 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.

Lira + MetPlacebo + Met

Eligibility Criteria

Age10 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Contact the study team to confirm eligibility.