临床试验/NCT00397631

NCT00397631已完成3 期

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus

Merck Sharp & Dohme LLC0 个研究点目标入组 520 人开始时间: 2006年12月19日最近更新: 2017年5月12日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 520
主要终点: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

排除标准

•Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
•Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months
•Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years

研究组 & 干预措施

1

Experimental

sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.

干预措施: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d (Drug)

结局指标

主要结局

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24

时间窗: Baseline and 24 weeks

HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

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)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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