CTRI/2009/091/000161已完成4 期
A 26 week randomised, multinational, open labelled, 2 armed, parallel group, treat-to-target once daily treatment trial with insulin detemir versus insulin glargine, both in combination with metformin in subjects with type 2 diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 444
- 试验地点
- 2
- 主要终点
- Change in HbA1C from baseline after 26 weeks of treatment
研究概览
简要总结
The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in type 2 diabetics inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD). 30 patients are proposed to be enrolled from India Total No of Subjects Enrolled In India:52 Trial ID:NN304-1768 Date of First Enrolment in India:13 Jul 2009
The study is completed globally
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
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with type 2 diabetes for at least 6 months Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or DPP-4 inhibitors) for at least 3 months Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed) HbA1c 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed) Body Mass Index (BMI) less than or equal to 35.0 kg/m2 Age 18 years and above.
排除标准
- •Any contraindication to insulin detemir or insulin glargine according to the local labelling Receipt of any investigational product within 4 weeks Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids) Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product Any other condition that the Investigator feels would interfere with trial participation or evaluation of results.
结局指标
主要结局
Change in HbA1C from baseline after 26 weeks of treatment
时间窗: 26 weeks of treatment
次要结局
- Glycaemic control as measured by fasting plasma glucose (FPG) (central laboratory values)(after 26 weeks of treatment)
- Change in body weight(26 weeks of treatment)
- Glycaemic control as measured by 9-point plasma glucose profile (self-measured)(after 26 weeks of treatment)
- Incidence of hypoglycaemic episodes during the trial: nocturnal and over 24 hours(after 26 weeks of treatment)
- Proportion of subjects achieving HbA1c of 6.5% or less(after 26 weeks of treatment)
- Proportion of subjects achieving HbA1c of 7.0% or less(after 26 weeks of treatment)
- Within-subject variation of self measured plasma glucose (SMPG) before breakfast during the trial(after 26 weeks of treatment)
研究者
研究点 (2)
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