CTRI/2015/02/005545已完成3 期
A 26-week Open Label, Randomised, 2-armed, Parallel Group, Multi-centre Trial Investigating Efficacy and Safety of Insulin Detemir Versus Insulin Neutral Protamine Hagedorn in Combination With Metformin and Diet/Exercise on Glycaemic Control in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin ± Other Oral Antidiabetic Drug(s) ± Basal Insulin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 5
- 主要终点
- Change in HbA1c (glycosylated haemoglobin)
研究概览
简要总结
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on metformin with or without other oral antidiabetic drug(s) with or without basal insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 10.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent from the subject or a legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities.Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial -Male or female, above or equal to 10 years and below or equal to 17 years at the time of signing informed consent/assent -Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening -Treated with a stable dose of metformin (1000-2000 mg/day) for at least 3 months prior to screening with or without other OAD(s) with or without basal insulin HbA1c (glycosylated haemoglobin) above or equal to 7.0% and below or equal to 10.5% (above or equal to 53 mmol/mol and below or equal to 91 mmol/mol) at screening.
排除标准
- •Maturity onset diabetes of the young (MODY) Fasting C-peptide at screening below 0.6 ng/mL Impaired liver function defined as alanine aminotransferase (ALT) above or equal to 2.5 times upper normal limit Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator.
结局指标
主要结局
Change in HbA1c (glycosylated haemoglobin)
时间窗: Week 0, Week 26
次要结局
- Proportion of subjects achieving HbA1c below 7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment(At week 26)
- Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes(Weeks 0 - 26)
- Change in body weight standard deviation score (SDS)(Week 0, Week 26)
- Proportion of subjects achieving HbA1c below 7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment(At Week 26)
- Incidence of adverse events (AEs)(Weeks 0 - 26)
- Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes(Weeks 0 - 26)
研究者
研究点 (5)
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