NCT00305604已完成3 期
A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 主要终点
- Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24
研究概览
简要总结
To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise
- •Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit
排除标准
- •Patients with type 1 diabetes
- •History of ketoacidosis or requires insulin use
- •Alanine aminotransferase / aspartate aminotransferase > 2.5 X ULN, triglycerides > 600 mg/dL, creatinine clearance < 35 mL/min
- •Fasting plasma glucose consistently > 260 mg/dL
- •Poorly controlled hypertension
研究组 & 干预措施
1
Active Comparator
sitagliptin
干预措施: sitagliptin phosphate (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24
时间窗: Baseline and Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
次要结局
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24(Baseline and Week 24)
- Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24(Baseline and Week 24)
- Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week(Week 1)
研究者
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Unknown
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