PER-096-06已完成未知
A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Determine the Efficacy, Safety, and Tolerability of AD-4833-536 in the Treatment of Subjects With Type 2 Diabetes
适应症
试验速览
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 0（—）
- 性别
- All
入选标准
- •1. The subject is male or female and is 18 years of age or older.
- •2. The subject has type 2 diabetes with an A1C ≥ 9.0 and ≤ 11.0% in the selection.
- •3. The patient has documented hypertension at the randomization visit.
- •4. The subject has followed a stable diet and exercise program in addition to taking metformin alone, or a combination of metformin and a sulphonylurea for a minimum period of 8 weeks before the selection.
- •5. If the subject is receiving antihypertensive therapy, can not be taking more than 3 agents and must have followed a stable regimen for a minimum of 4 weeks before the selection.
- •6. The subject has clinical laboratory evaluations within the reference range.
排除标准
- •1. The subject has type 1 diabetes mellitus.
- •2. The subject has a PSD> 100 mm Hg at the randomization visit.
- •3. The subject is currently taking an angiotensin II receptor blocker.
- •4. The subject is currently taking, or has taken at any time during the 4 weeks prior to the study or is expected to take the following medications: a) Any antidiabetic agent within the previous 12 weeks, except metformin or a combination of metformin and a sulfonylurea. b) Niacin> 200 mg per day. c) Tricyclic antidepressants or phenothiazines.
- •5. Subject has unstable angina or heart failure of any etiology with functional class III or IV.
- •6. Subject has a history of myocardial infarction (MI), cerebrovascular accident (CVA), percutaneous coronary intervention (PCI), aortocoronary bypass (AB) or transient ischemic attack (TIA) within the previous six months.
- •7. The subject has clinically significant defects in cardiac conduction.
- •8. The subject has secondary hypertension of some etiology.
- •9. The subject has a body mass index (BMI)> at 45 kg / m2.
- •10. The subject has significant renal failure.
- •11. The subject has a history of drug abuse or a history of alcohol abuse within the last 2 years.
- •12. The subject has a history of cancer that has not been in remission for at least 5 years before the first dose of study medication.
- •13. The subject has a level of alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times above the upper normal limit, active liver disease or jaundice.
- •14. The subject has serum potassium above the normal upper limit.
- •15. The subject is not willing or able to comply with the protocol or scheduled appointments.
- •16. The subject is not able to understand oral or written English or any other language in which a certified translation of the informed consent is available.
- •17. The subject is a pregnant woman, intends to become pregnant during the course of the study, or is breastfeeding.
- •18. The subject is currently participating in another experimental study or has participated in an experimental study within 30 days prior to randomization.
- •19. The subject suffers from any other serious illness or condition during the selection that could compromise the safety of the subject, affect the life expectancy of the subject or hinder the successful management and follow-up of the subject according to the protocol.
- •20. Subject has hypersensitivity to ARB II.
- •21. Subject has hypersensitivity to TZD.
研究者
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