CONSENT - Comparison of metfOrmin XR to IR as moNotherapy in the Newly diagnoSed Type 2 diabEtes Patients for the gastroiNtestinal Tolerability and Efficacy: a Randomized, Parallel Control, Open-label and Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 532
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
研究概览
简要总结
This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter trial in which metformin extended release (XR) will be compared with metformin immediate release (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed subjects with Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to 10.0 percent (%).
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 79 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
Metformin IR
干预措施: Metformin IR (Drug)
Metformin XR
干预措施: Metformin XR (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
时间窗: Baseline, Week 16
Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period
时间窗: Baseline up to Week 16
An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
次要结局
- Percentage of Subjects With Marked Hyperglycemia(Baseline up to Week 16)
- Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)(Baseline up to Week 16)
- Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16(Baseline, Week 1, 2, 4, 8, 12,16)
- Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period(Baseline up to Week 16)
- Percentage of Subjects With HbA1c Less Than (<) 7%(Baseline up to Week 16)
- Percentage of Subjects Who Are Totally Intolerant to the Treatment(Baseline up to Week 16)
- Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16(Baseline, Week 8 and 16)
- Percentage of Subjects With Hypoglycemia(Baseline up to Week 16)
- Percentage of Subjects Who Are Compliant to Treatment(Baseline up to Week 16)