Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

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