Efficacy and safety of liraglutide in combination with metformin versus metformin 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

ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Children and adolescents between the ages of 10â??17 years. Subjects cannot turn 18 before completion of the 14 week double blind period (Visit 11)
•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. The metformin dose must be stable for at least 30 days prior to screening (Visit 1)
•HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin
•Body mass index (BMI) above 85% percentile of the general age and gender matched population

•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 or major 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 investigatorâ??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 narcotics

发起方

ovo Nordisk AS