Efficacy and safety of liraglutide in combination with metformin compared to metformin alone, in children and adolescents with type 2 diabetes.

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-002605-29-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-13
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

- Children and adolescents between the ages of 14–16 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 90 days with diet and exercise alone, or diet and exercise in combination with metformin monotherapy.
- HbA1c
- =7.0% and =11% if diet and exercise treated
- =6.5% and =11% if treated with metformin
- 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: 172
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

- Type 1 diabetes
- Maturity onset diabetes of the young (MODY)
- Use of any antidiabetic agent other than metformin within 90 days prior to screening. Short term treatment with insulin is allowed
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified