Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- HbA1c (Glycosylated Haemoglobin A1c)
研究概览
简要总结
This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.
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
- •Diagnosed with type 2 diabetes for at least 6 months before trial start
- •Treatment with at least 1000 mg metformin per day for at least 3 months
- •Insulin-naive (short-term insulin treatment of up to 14 days is allowed)
- •DPP-4 (dipeptidyl peptidase-4) inhibitor naive
- •HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis
- •BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2
- •Able and willing to take one subcutaneous injection every day
- •Able and willing to perform mandatory SMPG (self measured plasma glucose) measurements
排除标准
- •Known or suspected allergy or intolerance to any of the trial products or related products
- •Severe hypertension
- •Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
- •Cardiac disease, within the last 12 months
- •Impaired hepatic function
- •Impaired renal function
- •Proliferative retinopathy or macular oedema requiring acute treatment
- •Female of childbearing potential
- •Known or suspected abuse of alcohol, narcotics or illicit substances
研究组 & 干预措施
Comb
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
干预措施: insulin detemir (Drug)
Comb
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
干预措施: sitagliptin (Drug)
Comb
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
干预措施: metformin (Drug)
Sita
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
干预措施: sitagliptin (Drug)
Sita
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
干预措施: metformin (Drug)
Sita
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
干预措施: sulphonylurea (Drug)
结局指标
主要结局
HbA1c (Glycosylated Haemoglobin A1c)
时间窗: Week 26
次要结局
- Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%(Week 26)
- Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%(Week 26)
- Change in BMI (Body Mass Index)(Week 0, Week 26)
- Hypoglycemic Episodes: Night Time(Weeks 0-26)
- Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia(Week 26)
- Hypoglycemic Episodes(Weeks 0-26)
- Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia(Week 26)
- FPG (Fasting Plasma Glucose)(Week 26)
- Hypoglycemic Episodes: Day Time(Weeks 0-26)
- Change in Body Weight(Week 0, Week 26)
- Self-measured 9-point Plasma Glucose Profile(Week 26)