CTRI/2009/091/000123已完成3 期
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Subjects with Type 2 Diabetes
Takeda Global Research & Development Centre (Europe) Ltd (TGRD)61 AldwychLondon WC2B 4AE United Kingdom0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
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
入选标准
- •1.Has a diagnosis of type 2 diabetes mellitus with either:
- •a.Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or
- •b.Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.
- •2.Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
- •3.If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
- •4.Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- •5.Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
- •6.No major illness or debility that in the investigator's opinion prohibits the participant from completing the study.
排除标准
- •1.Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.
- •2.Hemoglobin less than or equal to 12 g/dL (less than or equal to 120 gm/L) for males or less than or equal to 10 g/dL (less than or equal to 100 gm/L) for females.
- •3.Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.
- •4.Calculated creatinine clearance less than or equal to 50 mL/min.
- •5.Thyroid-stimulating hormone level outside of the normal range.
- •6.History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening.
- •7.History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- •8.History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.
- •9.New York Heart Association Class III or IV heart failure regardless of therapy.
- •10.History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
- •11.History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- •12.History of infection with Human Immunodeficiency Virus.
- •13.History of a psychiatric disorder that will affect the subject's ability to participate in the study.
- •14.History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
- •15.History of alcohol or substance abuse within the 2 years prior to Screening.
- •16.History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening.
- •17.Receipt of any investigational drug within the 30 days prior to Screening.
- •18.Prior treatment in an investigational study of alogliptin.
- •19.Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the subject from the study.
- •20.Has donated more than 400 mL of blood within the 90 days preceding their participation in the study.
- •21.Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.
研究者
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