Efficacy and safety of liraglutide in combination with metformin compared to metformin alone, in children and adolescents with type 2 diabetes

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2013/10/004082
• Date of registration: 21-10-2013
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk AS
• Public title: Efficacy and safety of liraglutide in combination with metformin compared to metformin alone, in children and adolescents with type 2 diabetes
• Scientific title: Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with type 2 diabetes:A 26-week double-blind, randomised, parallel group, placebo controlled multi-centre trial followed by a 26-week open-label extension
• Date of first enrolment: 22-10-2013
• Target sample size: 94
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4847
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Serbia , Slovakia, Slovenia, Spain, Sweden, Switzerland, The former Yugoslav Republic of Macedonia, Turkey, United Kingdom, United States of America

Contacts

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd

Key inclusion & exclusion criteria

Inclusion criteria: Children and adolescents between the ages of 10â??17 years. Subjects cannot turn 18 before completion of the 14 week double blind period (Visit 11)



Diagnosis of type 2 diabetes mellitus and treated for at least 90 days with diet and exercise alone, or diet and exercise in combination with metformin monotherapy. The metformin dose must be stable for at least 30 days prior to screening (Visit 1)



HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin



Body mass index (BMI) above 85% percentile of the general age and gender matched population


Exclusion criteria: Type 1 diabetes



Maturity onset diabetes of the young (MODY)



Use of any antidiabetic agent other than metformin within 90 days prior to screening. Short term treatment with insulin is allowed



Recurrent severe or major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator



History of chronic pancreatitis or idiopathic acute pancreatitis



Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigatorâ??s opinion could interfere with results of the trial



Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children



Known or suspected abuse of alcohol or narcotics



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Diabetes Mellitus, Type 2 Health Condition 2: E11- Type 2 diabetes mellitus

Intervention(s)

Intervention1: Liraglutide + Metformin: Liraglutide- 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 14 weeks. Subjects will continue treatment in a 38 week open-labelled extension.
Metformin-Tablets administered for 14 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 38 week open-labelled extension.


Control Intervention1: Placebo + Metformin: Placebo- Administered subcutaneously (s.c., under the skin) once daily for 14 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if needed in the 38 week open-labelled extension.
Metformin-Tablets administered for 14 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 38 week open-labelled extension.

Primary Outcome(s)

Change in HbA1cTimepoint: Week 0, week 14

Secondary Outcome(s)

Number of subjects having HbA1c below 7.0%Timepoint: Week 14

Week 26

Week 52

Growth velocityTimepoint: Week 104

Week 156

Number of adverse eventsTimepoint: Week 53

week 104

Week 156

Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodesTimepoint: Week 14

Week 26

Week 52

Change from baseline in fasting plasma glucoseTimepoint: Week 0, week 14

Week 0, week 26

Week 0, week 52

Pubertal progressionTimepoint: Week 104

Week 156

Change from baseline in 7-point self-measured plasma glucoseTimepoint: Week 0, week 14

Week 0, week 26

Week 0, week 52

Number of subjects having HbA1c maximum 6.5%Timepoint: Week 14

Week 26

Week 52

Secondary ID(s)

U1111-1121-8743

NN2211-3659,Version 3.0,Dated 12 Oct 2012

NCT01541215

2011-002605-29

P/288/2010

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date: 11/12/2013
Contact:

Institutional Ethics committe of Madras diabetes research Foundation,conran smith road,gopalapuram,Chennai,Tamil Nadu

Status: Approved
Approval date: 08/01/2014
Contact:

All India Institute of Medical Sciences Ethics Committee,Room No. 102, 1st Floor, Old O.T. Block, Ansari Nagar,Dr. Rajesh Khadgawat

Status: Approved
Approval date: 30/04/2015
Contact:

Institutional Ethics Committee, Ramdevrao Hospital.

Status: Approved
Approval date: 15/09/2015
Contact:

Human welfare Ethics committee for human science and research,Diabetes Thyroid and Endocrine center

Status: Approved
Approval date: 28/10/2015
Contact:

Institutional Ethics Committee,Institute of Post Graduate Medical Education & Research, Dr. B.C. Roy Postgraduate Instutute of Basic Medical Sciences, 244, A.J.C. Bose Road, Kolkata - 700 020Dr. Subhankar Chowdhury

Status: Not Applicable
Approval date:
Contact:

Sagar Hospitals Ethics Committee