NCT01751321Unknown不适用
Glucose Variability With DPP-4 Inhibition
Research Clinical Centre of the Russian Railways, JSC0 个研究点目标入组 50 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- glucose variability
研究概览
简要总结
Glucose Variability With DPP-4 Inhibition
详细描述
Patients with Type 2 Diabetes, age 35-75y., will be included in this double blind randomized placebo controlled study.
The sample size of 50 patients completing the 30 day study period is based on statistical input from Merck Research Laboratories, Rahway NJ.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •receiving a stable dose of metformin ≥ 1500 mg
- •HbA1c 7,5% -10/0 %
排除标准
- •Type 1 diabetes
- •HbA1c < 7,5% and > 10,0%
研究组 & 干预措施
sitagliptin, metformin, placebo
Other
- group- 25 patients will take sitagliptin 50 mg and metformin 1000 mg twice in a day
- group- 25 patients will take placebo 50 mg and metformin 1000 mg twice in a day
干预措施: Sitagliptin, placebo (Drug)
结局指标
主要结局
glucose variability
时间窗: 1 month
次要结局
未报告次要终点
研究者
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