Efficacy and safety of liraglutide in combination with mettormin versus mettormin 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.

Phase 3

Withdrawn

Conditions: Diabetes
Diabetes Mellitus Type 2
10018424

Registration Number: NL-OMON43231

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 1

Inclusion Criteria

-Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks);- Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with:
- diet and exercise alone
- diet and exercise in combination with metformin monotherapy
- diet and exercise in combination with metformin and a stable* dose of basal insulin
- diet and exercise in combination with a stable* dose of basal insulin.
*Stable is defined as basal insulin adjustments up to 15%;- HbA1c
- *7.0% and *11% if diet and exercise treated
- *6.5% and *11% if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination
- Body mass index (BMI) >85th percentile of the general age and gender matched population

Exclusion Criteria

- Type 1 diabetes
- Maturity on set diabetes of the young (MODY)
- Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening
- Recurrent severe 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Change in HbA1c from baseline to week 26</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>At 26 and 52 weeks of treatment:<br /><br>- HbA1c <7.0% (yes/no)<br /><br>- HbA1c =<6.5% (yes/no)<br /><br>- HbA1c <7.0% without severe or minor hypoglycaemic episodes (yes/no)<br /><br>Change from baseline at 26 and 52 weeks of treatment in:<br /><br>- Fasting plasma glucose (FPG)<br /><br>- 7-point self-measured plasma glucose<br /><br>- Body weight<br /><br>-BMI standard deviation score (SDS)<br /><br>Safety<br /><br>- Adverse events (AEs) and serious adverse events (SAEs)<br /><br>- Safety follow-up after 1 and 2 years: AEs and SAEs, growth velocity and<br /><br>pubertal progression</p><br>