NCT00111631已完成2 期
A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 218
- 主要终点
- Absolute change from baseline in HbAlc\n
研究概览
简要总结
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients 18-75 years of age;
- •type 2 diabetes;
- •stable metformin therapy for >=3 months before screening.
排除标准
- •women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
- •type 1 diabetes;
- •any anti-hyperglycemic medication other than metformin in the last 3 months.
研究组 & 干预措施
1
Experimental
干预措施: Metformin (Drug)
1
Experimental
干预措施: DPP-IV Inhibitor (Drug)
2
Experimental
干预措施: DPP-IV Inhibitor (Drug)
2
Experimental
干预措施: Metformin (Drug)
3
Experimental
干预措施: DPP-IV Inhibitor (Drug)
3
Experimental
干预措施: Metformin (Drug)
4
Placebo Comparator
干预措施: Metformin (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute change from baseline in HbAlc\n
时间窗: Week 16
次要结局
- Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n(Week 16)
- AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n(Throughout study)
研究者
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