NCT00563225已完成3 期
A Multicenter, Non-Comparative, Open, Phase III Study to Evaluate the Efficacy and Safety of Insulin Glargine on Subjects With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 90
- 主要终点
- To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.
研究概览
简要总结
A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus diagnosed at least 3 years ago
- •Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry
- •Treated with OHA monotherapy over at least 1 year
- •HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit)
- •BMI < 40 kg/m2
- •No history of ketonemia
- •Women of childbearing potential using the medically approved contraceptive method
- •Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
结局指标
主要结局
To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.
次要结局
- To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.
研究者
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