PER-041-07未知未知
A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2007年8月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 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
- 年龄范围
- 0 至 0（—）
入选标准
- •1. The patient has T2DM.
- •2. The patient is ≥ 21 and ≤ 70 years of age on the day of signing the informed consent form.
- •3. The patient: a) Is not receiving oral antihyperglycemic drugs for a minimum of 10 weeks, and has an HbA1c ≥ 7.0% and ≤ 11.0%. OR b) Receiving a single oral antihyperglycaemic drug, and has an HbA1c ≥ 6.5% and ≤10.0%, OR c) Receiving a combined low dose oral antihyperglycemic drug, at a dose less than or equal to 50% of the maximum recommended dose of both components, and has an HbA1c ≥ 6.5% and ≤10.0%.
- •4. The patient is a man, or a woman who is unlikely to conceive.
- •5. The patient understands the study procedures, alternative treatments available, and the risks involved in the study, and voluntarily agrees to participate by providing written informed consent.
排除标准
- •1. The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
- •2. The patient has symptomatic hyperglycemia that requires immediate initiation or addition of antihyperglycemic therapy.
- •3. The patient has received treatment with a PPARy agonist within the last 3 months.
- •4. The patient has received treatment with insulin within the last 2 months.
- •5. The patient has received treatment with a GLP-1 mimetic or agonist.
- •6. The patient has a history of hypersensitivity or contraindication to metformin.
- •7. The patient is in a weight loss program and is not in the maintenance phase, or the patient has received treatment with a weight-loss drug within 8 weeks of Visit 1.
- •8. The patient has received treatment with an investigational drug within the previous 3 months or is participating in another clinical trial.
- •9. The patient receives or appears to require treatment with immunosuppressive / immunomodulatory agents or the patient receives or appears to require treatment for> 14 consecutive days or
- •Repeated cycles of pharmacological doses of corticosteroids.
- •10. The patient has undergone surgery within 30 days prior to Visit 1 or has planned major surgery.
- •11. The patient has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the last 3 months, or has any of the following in the last 6 months: Acute coronary syndrome, coronary artery surgery.
- •12. The patient has had a stroke or TIA.
- •13. The patient has a cardiac status of Class I - IV.
- •14. The patient has a systolic blood pressure> 150 mm Hg or diastolic blood pressure> 85 mm Hg.
- •15. The patient suffers from a severe peripheral vascular disease.
- •16. The patient suffers from active liver disease, active viral hepatitis or primary biliary cirrhosis.
- •17. The patient suffers from active nephropathy.
- •18. The patient is HIV positive.
- •19. The patient has a clinically significant hematologic disorder.
- •20. The patient is under treatment for hyperthyroidism.
- •21. The patient has a history of malignancy.
- •22. The patient is a user of recreational or illicit drugs, or has had a recent history of drug addiction or alcohol abuse or drug or alcohol dependence.
- •23. The patient does not accept to abstain from alcohol during the 48 hours prior to each clinical visit.
- •24. The patient has donated blood products or has undergone a phlebotomy> 300 mL within 8 weeks of signing the informed consent, or intends to donate blood products or receive blood products within the projected duration of the study.
- •25. The patient is pregnant, has a positive urine pregnancy test, expects to conceive within the projected duration of the study, or is breastfeeding.
- •26. The patient has poor mental performance or some other reason that makes it difficult for the patient to meet the requirements of the study.
- •27. The patient is unlikely to comply with study procedures and respect appointments, or is planning to move during the study.
- •28. The patient plans to donate eggs during the study.
- •29. The patient has a history or current evidence of a condition, therapy, laboratory abnormality or other circumstance that could represent a risk for the patient or make his participation not the most convenient for him, could confuse the results of the study, or interfere with patient participation throughout the study.
- •30. The patient has a laboratory value exclu
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