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
ovo Nordisk AS0 个研究点目标入组 52 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
研究者
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