Diabetes Mellitus, Type 2 MedDRA version: 20.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000072461
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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) >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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; 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 with metformin with or without basal insulin treatment in controlling glycaemia versus metformin and liraglutide placebo in children, and adolescents (ages 10–17 years) with type 2 diabetes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. HbA1c <7.0% (yes/no) 2. HbA1c =6.5% (yes/no) 3. HbA1c <7.0% without severe or minor hypoglycaemic episodes (yes/no) Change from baseline: 4. Fasting plasma glucose (FPG) 5. 7-point self-measured plasma glucose 6. body weight 7. BMI standard deviation score (SDS) Safety 8. Adverse events (AEs) and serious adverse events (SAEs) 9. Safety follow-up after 1 and 2 years: AEs and SAEs, growth velocity and pubertal progression ; Timepoint(s) of evaluation of this end point: 1-7: at 26 and 52 weeks of treatment 8-9: After 53 weeks, and after 1 and 2 years after LPLV | — |
Countries
Australia, Austria, Belgium, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Israel, Lebanon, Macedonia, the former Yugoslav Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed