NCT00909480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
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline
研究概览
简要总结
This trial is conducted in Asia, South America and the United States of America (USA).
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 subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).
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
- •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 dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
- •Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
- •HbA1c (glycosylated haemoglobin) 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/m^2
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
研究组 & 干预措施
IDet
Experimental
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
干预措施: insulin detemir (Drug)
IGlar
Active Comparator
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change in HbA1c From Baseline
时间窗: Week 0, Week 26
次要结局
- Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)(Week 26)
- Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%(Week 26)
- Hypoglycaemic Episodes, Diurnal(Weeks 0-26)
- Hypoglycaemic Episodes, Nocturnal(Weeks 0-26)
- Change in Body Weight From Baseline(Week 0, Week 26)
- Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia(Week 26)
- Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%(Week 26)
- Incidence of Hypoglycaemic Episodes During the Trial(Weeks 0-26)
- Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia(Week 26)
- Fasting Plasma Glucose (FPG)(Week 26)
- Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast(Week 26)
- Number of Subjects Having the Adverse Event "Incorrect Dose Administered"(Weeks 0-26)
- Hypoglycemic Episodes, Unclassifiable(Weeks 0-26)
研究者
研究点 (1)
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