NCT01630369已完成4 期
Multicenter, Open, Non-randomized 6 Months Study to Evaluate Efficacy and Safety Insuman® Basal, Insuman® Comb 25, Insuman® Rapid in Insulin-naÏve Patients With T2DM Who Received Baseline Education Course in the Diabetes School.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 552
- 试验地点
- 1
- 主要终点
- Decrease of Hb A1c ≥ 1%
研究概览
简要总结
Primary Objective:
- To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)
Secondary Objectives:
- To evaluate the percentage of patients with Hb A1c < 7.5%,
- To evaluate the rate of hypoglycaemia (symptomatic, severe)
- To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment
- To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment
- To assess the overall safety
- To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)
详细描述
6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Human Insulin
Experimental
Dosage of human insulin (Insuman Basal/Comb/Rapid) will be individually adjusted in accordance with the Summary of Product Characteristics (SmPC). Patients will follow the titration algorithm recommended by the physician.
干预措施: insulin human (HR1799) (Drug)
结局指标
主要结局
Decrease of Hb A1c ≥ 1%
时间窗: Baseline, 6 months
次要结局
- Percentage of patients with Hb A1c < 7.5%(6 months)
- Rate of hypoglycaemias (symptomatic, severe)(6 months)
- Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)(6 months)
- Change in FPG(Baseline 6 months)
- Number of patients with adverse events(6 months)
- Assessment of efficacy of education courses in Diabetes Schools(Baseline, 6 months)
研究者
研究点 (1)
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