Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; placebo; metformin
Intervention description: Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.; Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.; Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.
Intervention MeSH terms: Metformin; Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to assess the efficacy and safety
      of liraglutide in the paediatric population in order to potentially address the unmet need
      for treatment of children and adolescents with type 2 diabetes.
    

Eligibility 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 (Stable is defined as basal insulin adjustments up
        to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is
        defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11%
        (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin
        as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination
        - 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 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 above 99th percentile for age
        and gender in children - Known or suspected abuse of alcohol or drugs/narcotics