NCT00970424终止3 期
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Pioglitazone
Forest Laboratories118 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 252
- 试验地点
- 118
- 主要终点
- Hemoglobin A1c Level (HbA1c)
研究概览
简要总结
This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
- •BMI 20 to 48 kg/m2, inclusive
- •HbA1c 7.0% - 10.0%, inclusive
- •Age 18 to 85 years, inclusive
排除标准
- •Currently taking more than one oral hypoglycemic agent
- •Type 1 diabetes mellitus
研究组 & 干预措施
1
Placebo Comparator
placebo, oral tablet administered once daily on background of pioglitazone
干预措施: Placebo (Drug)
2
Experimental
dutogliptin, oral tablet administered once daily on background of pioglitazone
干预措施: Dutogliptin (Drug)
结局指标
主要结局
Hemoglobin A1c Level (HbA1c)
时间窗: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)
次要结局
- Fasting Plasma Glucose Level (FPG)(FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).)
研究者
研究点 (118)
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