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

Phase 1

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-002605-29-ES
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-22
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

- Children and adolescents between the ages of 10?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% and ?11% if diet and exercise treated
- ?6.5% and ?11% if treated with metformin
- Body mass index (BMI) >85% percentile of the general age and gender matched population
Are the trial subjects under 18? yes
Number of subjects for this age range: 172
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 investigator?s opinion could interfere with results of the trial
- Uncontrolled hypertension, treated or untreated >99th percentile for age and gender in children
- Known or suspected abuse of alcohol or narcotics

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the superiority of liraglutide at the maximum tolerated dose (0.6 mg, 1.2 mg, 1.8 mg) in combination with metformin in controlling glycaemia versus metformin and liraglutide placebo in children and adolescent (ages 10?17 years) with type 2 diabetes.;Secondary Objective: To assess and compare the effect of liraglutide in combination with metformin versus metformin alone on:<br>- Parameters of glycaemic control<br>- Safety and tolerability;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 14

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. HbA1c <7.0% (yes/no)<br>2. HbA1c ?6.5% (yes/no)<br>3. HbA1c <7.0% without severe or minor hypoglycaemic episodes (yes/no)<br><br>Change from baseline:<br>4. Fasting plasma glucose (FPG)<br>5. 7-point self-measured plasma glucose<br><br>Safety <br>6. Adverse events (AEs) and serious adverse events (SAEs)<br>7. Safety follow-up after 1 and 2 years: AEs and SAEs, growth velocity and pubertal progression;Timepoint(s) of evaluation of this end point: Endpoints 1-5: At 14, 26 and 52 weeks of treatment<br>Endpoints 6-7: After 53 weeks, and after 1 and 2 years after LPLV