PER-058-07已完成未知
A Randomized, Double-blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
DAIICHI SANKYO PHARMA DEVELOPMENT,0 个研究点目标入组 0 人开始时间: 2007年9月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 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
- 年龄范围
- 18 至 0（—）
- 性别
- All
入选标准
- •1. Be willing to give written informed consent.
- •2. Diagnosis of type 2 diabetes.
- •3. A1C ≥ 7.0% and ≤ 8.5%.
- •4. Male or female subjects ≥ 18 years of age.
- •5. Women who are able to conceive (fertile) should use an adequate method of contraception.
- •6. Peptide C without fasting> 0.5 ng / ml at the time of preselection.
- •7. Subjects currently receiving treatment with a stable dose of an approved anti-hyperglycemic medication other than thiazolidinedione given as monotherapy for at least 3 months before prescreening and willing to discontinue antihyperglycemic at Visit 2 or for the duration of the prescreening study.
- •8. Subjects not currently treated.
排除标准
- •1. History of type 1 diabetes and / or history of ketoacidosis.
- •2. History of long-term treatment with insulin.
- •3. History of previous failure of treatment with TZD or intolerance.
- •4. Treatment with a lipid lowering agent fibrate.
- •5. Confirmed fasting glucose repetition> 240 mg / dL during the period of pharmacological rest / stabilization and the initial phase with placebo.
- •6. Body mass index> 45 kg / m2 at the time of pre-selection.
- •7. History of weight loss> 10% during the 3 months prior to the preselection.
- •8. Pregnant or nursing woman.
- •9. SBP ≥ 180 mm Hg and / or DBP ≥ 110 mm Hg.
- •10. Any known background of ICC.
- •11. History of unstable angina, myocardial infarction, accident
- •cerebrovascular disease, transient ischemic attack or any revascularization within 6 months prior to the preselection.
- •12. History of malignancy.
- •13. Impaired liver function.
- •14. Evidence of current infectious liver disease.
- •15. Known infection by human immunodeficiency virus (HIV).
- •16. Known hemoglobinopathy or chronic anemia requiring specific treatment within 5 years prior to the prescreening visit.
- •17. History of alcohol or drug abuse within 1 year prior to prescreening.
- •18. History of unstable major psychiatric disorders.
- •19. Allergy or hypersensitivity known or suspected to TZD agents.
- •20. Clinically significant alterations in any analysis prior to randomization.
- •21. The values of the samples for analysis can not exceed the limits unless approved by the medical monitor and / or the sponsor:
- •22. Hematuria not explained.
- •23. Donation of 1 pint (0.5 liters) of blood or more within the previous 30 days.
- •24. Previous known or possible exposure to rivoglitazone.
- •25. Contraindication for treatment with 45 mg of pioglitazone per day.
- •26. Known or suspected allergy, hypersensitivity or intolerance to the excipients of the experimental drug in the study.
- •27. Participation in a medical intervention, surgical or pharmaceutical study within the previous 30 days.
- •28. Any condition or concomitant therapy that may pose a risk to the subject or make participation inappropriate for the subject.
- •29. Direct or family relationship with the sponsor, researcher or staff of the site affiliated with the study.
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