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

Phase 3

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

Registration Number: CTRI/2013/10/004082

Lead Sponsor: ovo Nordisk AS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1cTimepoint: Week 0, week 14 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Change from baseline in 7-point self-measured plasma glucoseTimepoint: Week 0, week 14 <br/ ><br>Week 0, week 26 <br/ ><br>Week 0, week 52 <br/ ><br>;Change from baseline in fasting plasma glucoseTimepoint: Week 0, week 14 <br/ ><br>Week 0, week 26 <br/ ><br>Week 0, week 52 <br/ ><br>;Growth velocityTimepoint: Week 104 <br/ ><br>Week 156;Number of adverse eventsTimepoint: Week 53 <br/ ><br>week 104 <br/ ><br>Week 156;Number of subjects having HbA1c below 7.0%Timepoint: Week 14 <br/ ><br>Week 26 <br/ ><br>Week 52 <br/ ><br>;Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodesTimepoint: Week 14 <br/ ><br>Week 26 <br/ ><br>Week 52 <br/ ><br>;Number of subjects having HbA1c maximum 6.5%Timepoint: Week 14 <br/ ><br>Week 26 <br/ ><br>Week 52 <br/ ><br>;Pubertal progressionTimepoint: Week 104 <br/ ><br>Week 156