EUCTR2011-003600-20-DE进行中（未招募）不适用
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Co-Administration of Sitagliptin and Atorvastatin in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin Monotherapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 825
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 is =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 at least one yes” answer to the following questions:
- •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 =6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory, or =12 months of spontaneous amenorrhea in women >45 years of age), (2) undergone a bilateral oophorectomy and/or hysterectomy, or bilateral tubal ligation.
- •b) Patient is of reproductive potential and agrees to remain abstinent 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 contraceptives, 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.
- •Metabolic Entry Criteria
- •4. Patient is currently on monotherapy with metformin at a dose of =1500 mg/day for at least 8 weeks and has a Visit 1/Screening Visit A1C =7% and =10%.
- •5. Patient is not on statin therapy or other 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).
- •At Visit 3/Day 1/Randomization
- •6. Patient has =85% compliance with both sitagliptin placebo and atorvastatin placebo during the single-blind run-in period (as determined by site-performed tablet count).
- •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 415
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 410
排除标准
- •1.Patient has a history of type 1 diabetes mellitus, 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).
- •2.Patient has ever taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or a GLP-1 mimetic (such as exenatide or liraglutide), or the patient has required insulin therapy within 12 weeks prior to signing informed consent.
- •3.Patient has been on a PPAR? agonist (TZD) within the prior 12 weeks.
- •4.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, bile-acid sequestrants, fibrates, niacin (>100 mg/day), or other lipid-modifying agents not listed above within 6 weeks prior to Visit 1/Screening Visit.
- •5.Patient is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks of signing the informed consent and does not agree to refrain from participating in any other study while participating in this study.
- •6.Patient is currently taking, or intends to take during the course of the study, any excluded medications as listed in Appendix 6.1. This includes, but is not limited to any potent inhibitor of CYP3A4 (e.g., itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, protease inhibitors, or nefazodone), or medications that could increase the risk of myopathy (e.g., cyclosporine).
- •7.Patient intends to consume >1.2 liters of grapefruit juice per day during the course of the study.
- •8.Patient is on or is likely to require treatment with =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
- •9.Patient has a history of hypersensitivity or any contraindication to sitagliptin, atorvastatin, metformin or glimepiride based upon the labels of the country of the investigational site.
- •10.Patient is on a weight loss program and not in the maintenance phase or has started a weight loss medication (such as orlistat or sibutramine) within the prior 8 weeks.
- •11.Patient has undergone a surgical procedure within the prior 4 weeks.
- •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, abdominal aortic aneurysm, and carotid artery disease (transient ischemic attacks or stroke of carotid origin or >50% obstruction of a carotid artery).
- •14.Patient has New York Heart Association (NYHA) Class III or IV congestive heart failure .
- •15.Patient has inadequately controlled hypertension (i.e., systolic blood pressure >160 mm Hg or diastolic >95 mm Hg).
- •16.Patient has a medical history of active liver disease (other than fatty liver) including primary biliary cirrhosis, chronic active hepatitis B or C or patient reports symptomatic gallbladder disease
- •17.Patient has chronic progressive neuromuscular disorder (such as multiple sclerosis or polymyositis).
- •18.Patient is HIV positive
- •19.Patient has a clinically significant hematological disorder (such as aplastic anemia, thrombocytopenia, or a myeloproliferative or myelodysplastic syndro
研究者
相似试验
进行中（未招募）
1 期
Sitagliptin with atorvastatin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin monotherapy.Type 2 diabetes mellitusMedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-003600-20-BGMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.825
进行中（未招募）
不适用
MK-5172 in Combination with MK-8742 with and without Ribavirin (RBV) in HCV patients who failed Prior pegylated interferon (peg-IFN) and RBV treatmentHepatitis CEUCTR2014-000824-12-FIMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc400
进行中（未招募）
1 期
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, and GT6 Infection who are on Opiate Substitution Therapy.MedDRA version: 20.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848Hepatitis CEUCTR2014-000343-32-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,301
进行中（未招募）
不适用
MK-5172 in Combination with MK-8742 with and without Ribavirin (RBV) in HCV patients who failed Prior pegylated interferon (peg-IFN) and RBV treatmentMedDRA version: 17.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsHepatitis CEUCTR2014-000824-12-NLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc400
进行中（未招募）
1 期
MK-5172 in Combination with MK-8742 in Treatment-Naïve SubjectsMedDRA version: 17.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848Hepatitis CEUCTR2014-000137-22-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.400