NCT01457911已完成3 期
A Multicenter, Randomized, Open-label, 2-arm Parallel Group, 20-week Study Comparing the Efficacy and Safety of Fixed-dose Combination of 1 mg Glimepiride and 250 mg Metformin (AMARYL M 1/250 mg) Versus Glimepiride (AMARYL®) in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin.
适应症
干预措施
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
- 244
- 试验地点
- 22
- 主要终点
- Absolute change in HbA1c
研究概览
简要总结
Primary Objective:
- To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.
Secondary Objectives:
- To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
- To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
- To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).
详细描述
The study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. Total study duration is up to 23 weeks.
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 80 Years（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
AMARYL M (Glimepiride and Metformin hydrochloride combination)
Experimental
AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal
干预措施: Glimepiride and Metformin hydrochloride combination (HOE490) (Drug)
AMARYL (Glimepiride)
Active Comparator
AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal
干预措施: Glimepiride (HOE490) (Drug)
结局指标
主要结局
Absolute change in HbA1c
时间窗: 20 weeks, from baseline to week 20
次要结局
- Absolute change in Fasting Plasma Glucose(20 weeks, from baseline to week 20)
- Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively(20 weeks, at week 20)
- Number of patients reporting adverse events(20 weeks, from baseline to week 20)
- Number of patients reporting serious adverse events(20 weeks, from baseline to week 20)
- Hypoglycemia(20 weeks, from baseline to week 20)
- Vital signs(20 weeks, from baseline to week 20)
- Hematology, Serum chemistry and lipids(20 weeks, from baseline to week 20)
研究者
研究点 (22)
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