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

Study ID
NN2211-3659

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact


Principal Investigator

Official Title

Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

Brief Overview


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.

Participant Eligibility


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