Efficacy and safety of liraglutide in combination with mettormin versus mettormin monotherapy on glycaemic control in children and adolescents with type 2 diabetes A 26-week double-blind, randomised, parallel group, placebo controlled multi-centre trial followed by a 26-week open-label extension. - NN2211-3659/EIIipse

ovo Nordisk0 个研究点目标入组 1 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•-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) >85th percentile of the general age and gender matched population

•- Type 1 diabetes
•- Maturity on set 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

发起方

ovo Nordisk