PER-132-09已完成未知
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •Male or female subjects 18 years of age or older who have a diagnosis of T2DM, who either are receiving monotherapy or combination antidiabetic therapy (with the exception of a DPP-4 inhibitor or GLP-1 analogue) prior to Screening.
- •Subjects must meet the following HbA1c requirements based on the following baseline therapy: (please note that HbA1c can be repeated during Screening): If a subject’s antidiabetic regimen includes oral monotherapy or oral combination therapy, the subject must have an HbA1c level between 6.5% and 11.0%, inclusive, at Screening. If the subject’s antidiabetic regimen includes insulin, the subject must have an HbA1c level between 7% and 11%, inclusive, at Screening.
- •Subject has a history of ACS (acute MI or unstable angina requiring hospitalization as defined in Appendix E) within 15 to 90 days prior to randomization.
- •Female subjects of childbearing potential who are sexually active who agree to routinely use adequate contraception from Screening throughout the duration of the study.
- •Subject or the subject’s legally acceptable representative is able and willing to provide written informed consent prior to the initiation of any study procedures.
- •The subject is capable of understanding and complying with protocol requirements, including scheduled clinic appointments.
排除标准
- •Subject has signs of or is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
- •Subject is currently receiving a GLP-1 analogue for glycemic control of T2DM at Screening.
- •Subject has received a DPP-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.
- •Subject has any hemodynamically unstable CV disorder including heart failure (NYHA Class 4), refractory angina, uncontrolled arrhythmias, critical valvular heart disease, and severe hypertension at Screening.
- •Subject has had an ACS event less than 15 days prior to randomization according to the definition outlined in Appendix E of protocol.
- •Subject is hospitalized at Baseline/Randomization Visit. Subjects who have been discharged from an acute hospital to a cardiac rehabilitation center or nursing home at Baseline/Randomization Visit are not excluded.
- •Subject has received dialysis within 14 days prior to Screening.
- •Subject has a history of infection with human immunodeficiency virus.
- •Subject has a history of alcohol or substance abuse within the 6 months prior to the Screening Visit.
- •Subject has received any investigational drug within the 30 days prior to the Screening Visit or has received an investigational antidiabetic drug within the 3 months prior to the Screening Visit.
- •Subject has any major illness or debility that, in the investigator’s opinion, prohibits the subject from participating in the study.
- •The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, and sibling) of a study site employee who is involved in conduct of this study.
- •Subject is pregnant (confirmed by laboratory testing, ie, serum/urine human chorionic gonadotropin [hCG]) in females of childbearing potential), intends to become pregnant during the study, or is lactating.
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