NCT00875394已完成3 期
A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin
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
- 68
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24
研究概览
简要总结
After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy
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
- None
入排标准
- 年龄范围
- 30 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Has Type 2 Diabetes Mellitus
- •Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
- •Patient Is Currently On Metformin Therapy (1500 Mg/Day)
- •Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
- •Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
- •Patient Has An A1c of 6.5 % - 11.0%
排除标准
- •Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis
研究组 & 干预措施
1
Experimental
sitagliptin + metformin
干预措施: sitagliptin phosphate (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24
时间窗: Baseline and 24 weeks
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
次要结局
未报告次要终点
研究者
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