A Multicenter, Randomized, Double-Blinded, Monotherapy-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of the Acarbose and Metformin in Loose-Dose Combination Compared to Metformin Monotherapy in Subjects WithType 2 Diabetic Mellitus (T2DM) That is Inadequately Controlled by Metformin Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 287
- 试验地点
- 29
- 主要终点
- Absolute change in the levels of glycosylated hemoglobin (HbA1c)
研究概览
简要总结
To demonstrate the efficacy and safety of acarbose and metformin loose-dose combination as compared to metformin monotherapy in the treatment of subjects with T2DM that is inadequately controlled by metformin alone
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, aged 18 to less than 80 years
- •Diabetes mellitus type 2, that is insufficently controlled with metformin defined by HbA1c between 7.0 % and 10.0%, inclusive
- •Body mass index between 22 and 45 kg/m^2, inclusive
- •Women and men of reproductive potential must agree to use adequate contraception when sexually active
排除标准
- •Fasting plasma glucose > 14.0 mmol/L
- •Severe metabolic diabetic complications
研究组 & 干预措施
Acarbose plus metformin arm
Participants received loose combination of acarbose and metformin 3 times daily.
干预措施: Acarbose (Drug)
Acarbose plus metformin arm
Participants received loose combination of acarbose and metformin 3 times daily.
干预措施: Metformin (Drug)
Acarbose plus metformin arm
Participants received loose combination of acarbose and metformin 3 times daily.
干预措施: Placebo (Drug)
Metformin plus placebo arm
Participants received loose combination of placebo and metformin 3 times daily.
干预措施: Metformin (Drug)
Metformin plus placebo arm
Participants received loose combination of placebo and metformin 3 times daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute change in the levels of glycosylated hemoglobin (HbA1c)
时间窗: At baseline and at treatment week 16
次要结局
- Responder rates(At week 16)
- Change in 2-hour postprandial plasma glucose (PPG)(At baseline and at treatment week 16)
- Change in fasting plasma glucose (FPG) levels(At baseline and at treatment week 16)
- Change in fasting serum insulin levels(At baseline and at treatment week 16)
- Change in insulin resistance score(At baseline and at treatment week 16)
- Number of participants with adverse events(Up to 16 weeks)