A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 167
- 试验地点
- 13
- 主要终点
- Change in HbA1c
研究概览
简要总结
Primary Objective:
-To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.
Secondary Objective:
To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:
- Percentage of patients reaching HbA1c <7%
- Percentage of patients reaching HbA1c <6.5%.
- Fasting Plasma Glucose (FPG)
- Safety and tolerability
详细描述
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.
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
- 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
Arm 1
24-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.
干预措施: Glimepiride+metformin (Amaryl M®) - HOE4900 (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: from baseline to week 24
次要结局
- Percentage of patients with HbA1c < 6.5%(at week 24)
- Hypoglycemia(over the 24-week treatment period)
- Percentage of patients with HbA1c < 7%(at week 24)
- Change in Fasting Plasma Glucose (FPG)(from baseline to week 24)
- Number of patients with adverse events(over the 24-week treatment period)