EUCTR2011-001752-10-HU进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Placebo and Sitagliptin 100 mg When Used in Combination with Metformin in Subjects with Type 2 Diabetes
Takeda Global Research & Development Centre (Europe) Ltd.0 个研究点目标入组 1,078 人开始时间: 2012年7月12日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,078
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject eligibility is determined according to the following criteria:
- •1. The subject is male or female and 18 years of age or older with a historical diagnosis of type 2 diabetes mellitus-T2DM.
- •2. The subject meets one of the following criteria:
- •– The subject has an HbA1c level =7.5 and <10.5%, and has been on a stable daily dose of =1500 mg (or documented maximum tolerated dose [MTD]) of metformin for at least 8 weeks prior to Screening. This subject will immediately enter the Placebo Run-in Period according to Study Schedule A, or;
- •– The subject has an HbA1c level =7.5 and <10.5%, and has been on a stable daily dose of <1500 mg of metformin without documented MTD for at least 8 weeks prior to Screening. After completing the Screening Visit, this subject will have their metformin dose immediately increased to =1500 mg (or MTD) for an 8-week Titration Period according to Study Schedule B. Following this 8-week period, the subject must qualify for entry into the Placebo Run-in Period by completing the Week -3 procedures including having an HbA1c level =7.5 and <10.5%.
- •3. The subject has had no treatment with antidiabetic agents other than metformin within 2 months prior to Screening (Exception: if a subject has received other antidiabetic therapy for =7 days within the 2 months prior to Screening).
- •4. The subject has a body mass index (BMI) =45 kg/m² at Screening.
- •5. Subjects regularly using other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the counter medications is allowed at the discretion of the investigator.
- •6. The subject is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete subject diaries.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 432
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 646
排除标准
- •1. The subject donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
- •2. Hemoglobin =12 g/dL (=120 g/L) for males and =10 g/dL (=100 g/L) for females at Screening Visit.
- •3. The subject has systolic blood pressure =160 mm Hg or diastolic pressure =95 mm Hg at Screening Visit. (If the subject meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement.)
- •4. The subject has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
- •5. The subject has had treatment for gastric banding or gastric bypass surgery within one year prior to Screening.
- •6. The subject had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction,
- •unstable angina pectoris, clinically significant abnormal ECG, cerebrovascular accident or transient ischemic attack within 3 months prior to or at Screening.
- •7. The subject has a history of pancreatitis.
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