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

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-07
• Study Completion: 2018-05-23
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 135

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* dose of basal insulin
- diet and exercise in combination with a stable* dose of basal insulin.
*Stable is defined as basal insulin adjustments up to 15%
- HbA1c
- =7.0% and =11% if diet and exercise treated
- =6.5% and =11% if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination
- 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: 150
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 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 >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