Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with type 2 diabetes

ovo Nordisk A/S0 个研究点目标入组 135 人开始时间: 2015年7月30日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•-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%
•- =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: 94
•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

•- 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

发起方