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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: liraglutide; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541215

P/288/2010 (Other Identifier)

CTRI/2013/10/004082 (Registry Identifier)

U1111-1121-8743 (Other Identifier)

2011-002605-29 (EudraCT Number)

NN2211-3659

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups, including a placebo group

Lira + Met

Experimental group

Treatment:

Drug: liraglutide

Drug: metformin

Placebo + Met

Placebo Comparator group

Treatment:

Drug: metformin

Drug: placebo