Phase 3 Study of Combination of Mitiglinide and Metformin in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 13
- 主要终点
- the change in HbA1c from randomization to endpoint
研究概览
简要总结
We performed a prospective, randomized, multicenter trial to assess the efficacy and safety of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who show inadequate glycemic control with metformin monotherapy. Subjects with HbA1c >7.0% after an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus mitiglinide (Met+Mit) or metformin plus placebo (Met).
详细描述
This was a 16-week, randomized, double-blind study for comparing metformin plus mitiglinide (Met+Mit) versus metformin plus placebo (Met+Pcb). An 8-week metformin run-in phase (500 mg twice a day for the first 4 weeks and 500 mg three times a day for the following 4 weeks) was followed by a 16-week trial phase (mitiglinide 10 mg or placebo three times a day added to metformin 500 mg three times a day). The subjects with an HbA1c >7.0% at the end of the metformin run-in phase were randomized to a Met+Mit group or a Met+Pcb group of the trial phase.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 30-70 years
- •had a duration of diabetes of <10 years
- •body mass index (BMI) 20-35 kg/m2
- •a plasma HbA1c level of 7.5-11% during the previous 4 weeks
排除标准
- •subjects who were diagnosed with type 1 diabetes, gestational diabetes, or diabetes with any specific causes
- •Subjects who had been treated with nateglinide, repaglinide, metformin (over 1,000 mg/day), or sulfonylurea (over a quarter of the maximum recommended dose) during the previous 8 weeks
研究组 & 干预措施
Metformin+Mitiglinide
mitiglinide 10 mg three times a day added to metformin 500 mg three times a day
干预措施: Mitiglinide (Drug)
Metformin+Placebo
placebo three times a day added to metformin 500 mg three times a day
干预措施: Placebo (Drug)
结局指标
主要结局
the change in HbA1c from randomization to endpoint
时间窗: 16 weeks after radomization
次要结局
- the proportion of subjects with HbA1c <7% after 16 weeks of treatment and the change in FPG and 2-hr postprandial glucose (PPG) from baseline(16 weeks after radomization)