PER-007-13未知未知
A PHASE III , RANDOMIZED , DOUBLE-BLIND, CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF MK-0431D (A FIXED-DOSE COMBINATION [FDC] OF SITAGLIPTIN AND SIMVASTATIN) FOR THE TREARMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS (T2DM) WITH INADEQUATE GLYCE-MIC CONTRIL IN METFORMIN MONOTHERAPY.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,0 个研究点目标入组 0 人开始时间: 2013年5月27日最近更新:
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
- 18 至 79（—）
入选标准
- •Patients must meet all of the followings criteria to participate in the study
- •At Visit 1/ Screening Vist
- •1) Patients has T2DM and must be 18 and 79 years of age on the day of signing informed consent,
- •2) Patient is a male or a femail who is higly unlikely to conceive as indicated by meeting at least one of the following criteria :
- •a) The patient is not reproductive potential. A female patient who is not of reproductive potential is defined as one who has either: (1) reached natural menopause (defined as ≥ 12 months of spontaneous amenorrhea in women> 45 years of age or ≥ 6 months of spontaneous amenorrhea with serum FSH levels in a postmenopausal range as determined by the laboratory) or (2) had bilateral oophorectomy and / or hysterectomy, or had bilateral tubal ligation at least 6 weeks prior to screening.
- •b) Patient is of reproductive potential and agrees to remain abstinence or use (or have their partner use) two acceptable methods of birth control within the projected duration of the study and for 14 days after the last dose of study medication. Acceptable methods of birth control are: hormonal contraception, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
- •3. Patient understands the study procedures, alternative treatments available and the risks involved with the study, and voluntarily agree to participate by giving informed written consent.
- •4. Provide written informed consent / assent for the trial. The subject may also provide consent / assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •Metabolic entry criteria
- •5. Patient is currently on monotherapy with metformin at a dose of ≥ 1500 mg / day for at least 10 weeks and has a Visit 1 / Screening Visit A1C ≥ 7% and ≤ 10%
- •6. Patient is not on lipid- lowering agents for at least 6weeks and has a Visit 1 / Screening Visit LDL-C ≥ 70 mg / dl (1.81 mmol / l) ≤ 130 mg / dl (3.37 mmol / l).
- •NOTE: Patients on other lipid-lowering agents (eg., Fibrate or fenofibrate) are excluded – The list of excluded lipid-modifying medication are in the Appendix 6.1.
- •At Visit 3/day 1/Randomization
- •7. Patient has≥ 85% compliance (as mensured by tablet count) with placebo treatment during the run-in.
排除标准
- •Patients must be excluded if they meet any of the following criteria.
- •At Visit 1 / Screening VisitGlucose metabolism and Therapy criteria
- •1. Patient has a history of type 1 diabetes mellitus or history of ketoacidosis, or patient is aasessed by the investigator as possible haveing type 1 diabetes confirmed with a C-peptide <0.7 ng / ml (0.23 nmol / l).
- •Note: Only a patient assessed by the investigator as possibly having type 1 diabetes should have C-pepide meansured ar at Visit 1/Screening Visit..
- •Patients requiring specific treatments
- •2. Patient has been on thiazolidinediones (TZDs) within the previous 16 weeks.
- •3. The patient has been treated with a statin or other lipid-lowering agents, including over the counter (OTC ) supplements of fish oil containing > 100 mg / day of EPA + DHA , ), red yeast rice extract , Cholestin, fibrates, niacin (> 100 mg / day) or other lipid modifying agents not listed above in the 6 weeks prior to Visit 1/Screening Visit (see Appendix 6.1 for the list of excluded medication) .
- •Note (1): A patient must not had prior lipid modifying agents discontinued solely for the the purpose of potentially qualifying for this study.
- •Note (2): A patient currently use psyllium, other fiber-based laxatives, phytosterols margarine and / or other OTC therapies not listed above that are known to affect serum lipid levelsmust be on stable dose regimen for at least 4 weeks prior Visit 1/Screening Visit , and remain on a constant regimen of the duration of the study.
- •4. Patient is currently participating or has participated in another study in which the patient received an investigational compound or used an investigational device in the 12 weeks of signing the informed consent or is not willing to refrain from participating in any another study.
- •Note: A patient who has participated in a non-interventional study may be enrolled.
- •5. Patient is currently on or is likely to require treatment with a prohibited medication (see Appendix 6.1 for a list of excluded medications).
- •6. Patient intends to consume> 1.2 liters of grapefruit juice per day during the course of the study.
- •7. Patient is on or likely to require for ≥ 2 consecutive weeks, or repeated courses of pharmacological doses of corticosteroids.
- •Note: inhaled nasal and topical corticosteroids are permitted.
- •8. Patient has a history of intolerance or hypersensitivity or any contraindication to sitagliptin, simvastatin, metformin or glimepiride based upon the labels of the country of the investigational site..
- •9. Patient is om a weight loss program and not in the maintenance phase, or has started loss medication or has undergone bariatric surgery within 12 months prior to signing the informed consent.
- •10. Patient has undergone a surgical procedure within 4 weeks prior to signing the informed consent or has planned major surgery during the study.
- •Note: A patient who has undergone minor surgery in the prior 4 weeks and is fully recovered or a patient who has planned minor surgery may participle Minor surgery is defined as a surgical procedure involving local anesthesia.
- •Concomitant disease of organs and systems
- •11. Patient has symptomatic hyperglycemia that, in the investigator’s opinion, requires immediate imitation , adjustment or addition of antihyperglycemic therapy.
- •12. Patient has a history of myopathy or rhabdomyolysis with any statin.
- •13. Patient has c
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