CTRI/2021/10/037574已完成4 期
Comparison of efficacy and safety of Viladagliptin 50 mg tablet twice daily and metformin combination therapy with Vildagliptin 100 mg sustained release tablet once daily and metformin combination therapy in Indian patients with type 2 diabetes mellitus: A randomized open label phase IV clinical trial
Dr Rudra Paul1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年1月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in HbA1C At week 12 visit
研究概览
简要总结
Present study is aimed to compare efficacy and safety of Metformin and Vildagliptin 100 mg SR combination therapy with Metformin and Vildagliptin 50 mg twice daily combination therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Age > 18 yrs 2 Newly Diagnosed cases with type 2 diabetes mellitus 3 HbA1C ≥ 6.5 & ≤ 8.
排除标准
- •ï¶Female patients who are pregnant or lactating 1 FPG > 250mg/dl, PPPG > 350mg/dl 2 Co-morbid cardiovascular, hepatic renal and psychatric complications 3 Co-administration of drugs that are likely to interact with vildagliptin or metformin.
结局指标
主要结局
Change in HbA1C At week 12 visit
时间窗: Change in HbA1C At week 12 visit
次要结局
- Change in FPG, PPPG at week 4, 8 and 12 visits(At the intervals of weeks 4, 8 and 12)
研究者
研究点 (1)
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