NCT00604396已完成3 期
Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 477
- 试验地点
- 63
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Europe.
The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.
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 for at least 12 months since diagnosis
- •Insulin naive subjects
- •OAD treatment for at least 4 months alone or combined with no more than two OADs
- •Body mass index (BMI) below 35.0 kg/m2
- •HbA1c between 7.5-10.0%
- •Able and willing to use twice a day injections for the entire trial period
排除标准
- •Current or previous treatment with thiazolidiones within the last 6 months
- •OAD treatment with three or more OADs within the last 6 months
- •Acute insulin treatment for longer than 7 days in a row within the last 6 months
- •Secondary diabetes
- •Known maturity onset of diabetes of young (MODY)
- •Known or suspected allergy to trial product or related products
结局指标
主要结局
HbA1c
时间窗: after 26 weeks of treatment
次要结局
- Incidence of total hypoglycaemic episodes
- Body weight
- Incidence of adverse events
- Insulin antibodies
- Fasting plasma glucose
- Within-subject variation
研究者
研究点 (63)
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