PER-061-05已完成未知
MULTICENTER STUDY, RANDOMIZED, DOUBLE-BLIND, DOUBLE SIMULATION, PARALLEL GROUP, CONTROLLED WITH PLACEBO TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF THE ORAL GW677954 CAPSULES (2,5, 5,10, 15 AND 20 MG ONCE A DAY) AS A MONOTHERAPY (TREATED WITH DIET AND / OR EXERCISE) OR AS A SUPPLEMENT TO METFORMIN FOR 16 WEEKS IN SUBJECTS WITH DIABETES MELLITUS TYPE 2
GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 0 人开始时间: 2005年11月21日最近更新:
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
入选标准
- •1. Subjects with T2DM.
- •2. To be eligible for Randomization in the study, a subject must meet all of the following glycemic criteria: a) HbA1c level via the central laboratory in the pre-selection visit. b) If HbA1c is> 8.0% but <10.0%, the subject can proceed to Randomization. c) If the HbAic> 7.8% but <8.0%, the subject is not eligible. d) • If the HbAic is <7.8%, the subject is not eligible to proceed. e) The level of PPG via the central laboratory at the pre-selection visit should be <270 mg / dL (15.0 mmol / L).
- •3. Concurrent therapy for T2DM: a) Treated with diet and / or exercises. b) Monotherapy with metformin.
- •4. Men and women from 18 to 70 years of age.
- •5. If the patient is female, he is eligible to enter and participate in the present study: a) If he has no potential to have children or b) If he has potential to have children, and has a negative pregnancy test and if he uses acceptable contraceptive methods.
- •6. Body Mass Index (BMI):> 25 and <40 kg / m2 and weigh at least 50 kg in the Selection.
- •7. If the subject is a smoker, he should be able to abstain while in the clinic at each visit.
- •8. Subjects provided full written informed consent before any procedure related to the study was performed.
排除标准
- •1. Metabolic disease.
- •2. Previous use of insulin for the treatment of hyperglycemia within 3 months of the Selection.
- •3. History of a recent clinically significant cardiovascular disease.
- •4. History of chronic pancreatitis.
- •5. Familial hypercholesterolemia.
- •6. TGs> 800 mg / dL (8.96 mmol / L) in the Selection.
- •7. Serum creatinine in the selection> 1.4 mg / dL (124 pmol / L) for women, or> 1.5 mg / dL (133 pmol / L) for men.
- •8. Clinically significant anemia.
- •9. History of significant co-morbid diseases.
- •10. Documented history of hepato-biliary disease.
- •11. History of metabolic acidosis, rhabdomyolysis, myalgia, myositis or myopathy after taking statins or fibrates.
- •12. Any subject who withdrew from therapy due to AEs after taking PPARy or a dual PPAR agonist and / or marketed.
- •13. Signs or symptoms of myositis in the Selection.
- •14. Who is currently taking or has taken any of the following medications 3 months before the pre-selection visit: a) Anti-obesity agents b) St, John´s Wort c) Warfarin and gold anticoagulants d) Digoxin e) Oral or injectable corticosteroids f) Antidiabetic agents (apart from metformin) g) TZDs 3 months before the pre-selection visit. h) Methotrexate, cyclosporine or monoclonal antibodies i) Atypical antipsychotic drugs j) Antiretroviral drugs k) Lipid reducing agents within 3 months prior to the pre-selection visit. l) Monoamine oxidase inhibitors
- •15. History of cancer.
- •16. Women who are breastfeeding, pregnant or who plan to become pregnant.
- •17. Idiosyncrasy or known immediate or delayed reaction of hypersensitivity to any drug chemically related to the study drug.
- •18. Known allergy to any of the excipients of the capsule, and history of allergies to the drug or other allergies that contradict participation.
- •19. Presents a history of abuse of a substance and / or alcohol within the last year.
- •20. He received treatment with a new molecular entity in the
- •4 months prior or participated in any other study during the previous 3 months, or has participated in a previous study with GW677954.
- •21. Likely to not comply with the protocol or scheduled visits.
- •22. The subject presents any concomitant medical condition that makes it unsuitable for participating in the study.
- •23. The subject is a close member of the family of a participating researcher, study coordinator, employee of an investigator; or a staff member who conducts the study.
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