EUCTR2008-000959-10-HU进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety ofAlogliptin Compared to Glipizide in Elderly Subjects with Type 2 Diabetes - SYR-303
Takeda Global Research & Development Centre (Europe) Limited,0 个研究点目标入组 470 人开始时间: 2008年10月6日最近更新:
适应症
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
- 470
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
- •1. The subject is male or female, between the ages of 65 and 90, inclusive, with a diagnosis of type 2 diabetes mellitus who has either:
- •a) Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control (defined as an HbA1c concentration between 6.5% and 9.0%, inclusive) while receiving no antidiabetic treatment (defined as less than 7 days of any antidiabetic treatment) within the two months prior to Screening (Study Schedule A). Subjects following Schedule A may be randomized immediately upon confirmation of eligibility.
- •b) Failed treatment with oral monotherapy alone as demonstrated by inadequate glycemic control (defined as an HbA1c concentration between 6.5% and 8.0%, inclusive) within the two months prior to Screening (Study Schedule B). Subjects following Schedule B will undergo a 4-week washout period including an assessment at the end of washout to re-confirm eligibility prior to randomization (see additional inclusion criteria).
- •2. Body mass index =23 kg/m2 and =45 kg/m2.
- •3. Subject is capable of understanding and complying with protocol requirements.
- •4. Subject or the subject’s legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
- •5. If regularly using other, non-excluded medications, must be on a stable dose for at least the 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. Neither pregnant (confirmed by laboratory testing in females of childbearing potential) nor lactating.
- •7. Female subjects of childbearing potential who is sexually active agrees to use adequate contraception (as defined in the informed consent form) from screening throughout the duration of the study.
- •8. Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
- •9. No major illness or debility that in the investigator’s opinion prohibits the subject fromcompleting the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Systolic blood pressure =160 mm Hg and/or diastolic pressure =100 mm Hg.
- •2. Hemoglobin =12 g/dL (=120 gm/L) for males or =10 g/dL (=100 gm/L) for females.
- •3. Alanine aminotransferase =3 x upper limit of normal.
- •4. Calculated creatinine clearance =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. (A history of treated CIN I or CIN II [cervical intraepithelial neoplasia] is allowed.)
- •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. Currently treated subjects who are stable at Class I or II are candidates for the study (see Appendix E).
- •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 HbA1c.
- •12. History of infection with HIV.
- •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. Subject is a study site employee, or is an immediate family member of a study site employee who is involved in the conduct of this study.
- •21. Subject has donated more than 400 mL of blood within the 90 days preceding their participation in the study.
- •22. Subjects who have hypersensitivity or have had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.
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