NCT01486966终止4 期
A 2-week, Randomised, Controlled, Open-label, Two-group Parallel, Multi-centre Trial Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin Both in a Basal Bolus Regimen With or Without Metformin in Chinese Inpatients With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.
The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer
- •Currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without OAD(s), and total daily insulin dose less than 1.4 IU (U)/kg (If treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months)
- •Body Mass Index (BMI) equal to 40 kg/m^2 or below
- •HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.0% by central laboratory analysis
- •Plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation
排除标准
- •Treatment with thiazolidinediones (TZD) or Glucagon-Like Peptide-1 (GLP-1) receptor agonists within the last 3 months prior to the screening
- •Anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (MAO) inhibitors
- •Previous participation in this trial (participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period.)
研究组 & 干预措施
Insulin detemir / IAsp
Experimental
干预措施: insulin detemir (Drug)
Insulin detemir / IAsp
Experimental
干预措施: insulin aspart (Drug)
Insulin detemir / IAsp
Experimental
干预措施: metformin (Drug)
insulin NPH
Active Comparator
干预措施: insulin NPH (Drug)
insulin NPH
Active Comparator
干预措施: human soluble insulin (Drug)
insulin NPH
Active Comparator
干预措施: metformin (Drug)
结局指标
主要结局
Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment
时间窗: Week 0, week 2
Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.
次要结局
- Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment(Week 2)
- Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment(Week 2)
- Change From Baseline in Fructosamine After Two Weeks of Treatment(Week 0, week 2)
- Incidence of Hypoglycaemic Episodes(Weeks 0-2)
- Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment(Week 0, week 2)
- Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment(Week 0, week 2)
- Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment(Week 0, week 2)
- Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment(Week 2)
- Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment(Week 2)
研究者
研究点 (1)
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