Efficacy and safety of liraglutide in combination with metformin compared to metformin alone, in children and adolescents with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 20.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000072461Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-002605-29-GB
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 135
-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) >85% percentile of the general age and gender matched population
Are the trial subjects under 18? yes
Number of subjects for this age range: 94
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
- Type 1 diabetes
- Maturity onset 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To assess and compare the effect of liraglutide versus placebo in combination with metformin with or without basal insulin treatment. ;Primary end point(s): Change in HbA1c ;Timepoint(s) of evaluation of this end point: From baseline to week 26;<br> Main Objective: To confirm the superiority of liraglutide at the maximum tolerated dose (0.6 mg, 1.2 mg or 1.8 mg)versus placebo when added to in combination<br> with metformin with or without basal insulin treatment in controlling glycaemia versus metformin and liraglutide placebo in children, and<br> adolescents (ages 10–17 years) with type 2 diabetes.<br>
- Secondary Outcome Measures
Name Time Method <br> 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> 6. body weight<br> 7. BMI standard deviation score (SDS)<br> <br> Safety <br> 8. Adverse events (AEs) and serious adverse events (SAEs)<br> 9. Safety follow-up after 1 and 2 years: AEs and SAEs, growth velocity and pubertal progression<br> ;<br> Timepoint(s) of evaluation of this end point: 1-7: at 26 and 52 weeks of treatment<br> 8-9: After 53 weeks, and after 1 and 2 years after LPLV<br>