EUCTR2012-001868-29-CZ进行中（未招募）1 期
A Phase III, Randomized, Double-Blind, Clinical Trial to Studythe Efficacy and Safety of MK-0431D (a fixed-dose combination[FDC] of sitagliptin and simvastatin) for the Treatment of PatientsWith Type 2 Diabetes Mellitus (T2DM) with Inadequate GlycemicControl on Metformin Monotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At Visit 1/Screening Visit
- •1. Patient 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 female who is highly unlikely to conceive as indicated by meeting at least one of the following criteria:
- •a) Patient is not of 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 the 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 abstinent or use (or have their partner use) two acceptable method 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 risks involved with the study, and voluntarily agrees 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 6 weeks and has a Visit 1/Screening Visit LDL-C =70 mg/dL (1.81 mmol/L) and =130 mg/dL (3.37 mmol/L).
- •NOTE: Patients on other lipid-lowering agents (e.g. fibrates or fenofibrates) are excluded. The list of excluded lipid-modifying medications are in Appendix 6.1.
- •At Visit 3/Day 1/Randomization
- •7. Patient has =85% compliance (as measured by tablet count) with placebo treatment during run-in.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •At Visit 1/Screening Visit
- •Glucose Metabolism and Therapy Criteria
- •1. Patient has a history of type 1 diabetes mellitus, or a history of ketoacidosis or patient is assessed by the investigator as possibly having type 1 diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L).
- •Patients Requiring Specific Treatments
- •2. Patient has been on a thiazolidinedione (TZD) within the prior 16 weeks.
- •3. Patient has been treated with a statin or other lipid-lowering agents, including over the counter (OTC) supplements of fish oils containing >100 mg/day of EPA+DHA, red yeast rice extract, Cholestin, fibrates, niacin (>100 mg/day), or other lipidmodifying
- •agents not listed above within 6 weeks prior to Visit 1/Screening Visit (see Appendix 6.1 for the list of excluded medications).
- •4. Patient is currently participating in or has participated in another study in which the patient received an investigational compound or used an investigational device within the prior 12 weeks of signing the informed consent or is not willing to refrain from participating in any other study.
- •5. Patient is currently on or 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 treatment for =2 consecutive weeks or repeated courses of pharmacologic doses of corticosteroids.
- •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 on a weight loss program and not in the maintenance phase or has started a weight 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 informed consent or has planned major surgery during the study.
- •Concomitant Disease of Organs and Systems
- •11. Patient has symptomatic hyperglycemia that, in the investigator’s opinion, requires immediate initiation, adjustment, or addition of antihyperglycemic therapy.
- •12. Patient has a history of myopathy or rhabdomyolysis with any statin.
- •13. Patient has cardiovascular disease as indicated by a history of one of the following:
- •acute coronary syndrome (e.g., myocardial infarction or unstable angina), stable
- •angina, coronary artery procedures (angioplasty or bypass surgery), evidence of
- •clinically significant myocardial ischemia, peripheral arterial disease, and carotid
- •artery disease (transient ischemic attacks or stroke of carotid origin or >50%
- •obstruction of a carotid artery).
- •14. Patient has a diagnosis of congestive heart failure with New York Heart Association
- •(NYHA) Class III or IV cardiac status (refer to Appendix 6.3).
- •15. Patient has a systolic blood pressure =160 mm Hg or a diastolic blood pressure
- •=90 mm Hg and blood pressure is unlikely to be within these limits at Visit 3/Day 1 with an adjustment in anti-hypertensive medication.
- •16. Patient has a medical history of active liver disease (other than non-alcoholic hepatic steatosis) including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease.
- •17. Patient has chronic progressive neuromuscular disorder (such as multiple sclerosis or polymyositis).
- •18. Patient has human immunodeficiency virus (
研究者
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