EUCTR2010-022193-13-DE进行中（未招募）不适用
A 66 week extension to:A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
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
- 663
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
- •-For patients not currently on AHA medication: A1C =7.0 and =10.0%
- •-For patients currently on oral AHA medication monotherapy or low dose dual oral combination therapy (except TZDs): A1C =6.5 and =9.0%
- •-BMI >20kg/m2 and <43kg/m2 (for Japan, BMI >18 kg/m2 and <43kg/m2
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
- •-Patient has previously been treated at any time with either an investigational or marketed DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or a GLP-1 receptor agonist (such as exenatide or liraglutide), or the patient has required insulin therapy within 14 weeks prior to signing informed consent.
- •-Patient is on or likely to require treatment with warfarin or warfarin-like anticoagulants, digoxin, any other medication with a narrow therapeutic index (see Appendix 6.10).
- •-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.
- •-Patient is HIV positive (as assessed by medical history).
- •-Patient has a diagnosis of CHF (congestive heart failure) with NYHA Class II - IV cardiac status (refer to Appendix 6.1), patient has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or had any of the following disorders within the past 3 months:
- •-Acute coronary syndrome (such as MI or unstable angina)
- •-Coronary artery intervention (CABG or PTCA)
- •-Stroke or transient ischemic neurological disorder
- •-Patient has poorly controlled hypertension defined as systolic blood pressure of =160 mm Hg or diastolic blood pressure of =90 mm Hg and blood pressure is not considered likely to be under these limits by Visit 3/Week -2 with an adjustment in antihypertensive medication.
- •-Patient has a history of a seizure disorder or central degenerative neurological disorder.
- •-Patient has a history of chronic muscle disorder, including chronic myopathies or muscular dystrophy.
- •-Patient has severe active peripheral vascular disease (such as manifested by claudication with minimal activity, a non-healing ischemic ulcer, or disease which is likely to require intervention such as with bypass or angioplasty).
- •-Patient has a history of malignancy or clinically important hematological disorder.
- •Exceptions: (1) Patients with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate; (2) Patients with other malignancies which have been successfully treated >5 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening. However, patients with a history of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, malignant melanoma, or renal cell carcinoma are ineligible for the study regardless of the time since treatment.
- •-Patient has a positive urine pregnancy test.
- •-At Visit 2, Patient has a QTc interval >480 ms for females, and >470 ms for males.
- •-At Visit 4, Patient has a site-fasting-fingerstick glucose (FFSG) <126 mg/dL (<7.0 mmol/L) or >260 mg/dL (>14.4 mmol/L).
研究者
相似试验
进行中（未招募）
不适用
A 66-Week Extension to: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding, Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control. (Original Study EudraCT # 2010-022193-13)Type 2 Diabetes MellitusEUCTR2011-000656-42-FIMSD Finland Oy510
进行中（未招募）
1 期
A 66-Week Extension to: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic ControlMedDRA version: 13.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2010-022193-13-LVMerck Sharp & Dohme Corp.663
进行中（未招募）
不适用
.A.Type 2 Diabetes MellitusEUCTR2011-000656-42-LTMerck Sharp & Dohme Corp.663
进行中（未招募）
不适用
A 66-Week Extension to: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic ControlType 2 Diabetes MellitusEUCTR2010-022193-13-DKMerck Sharp & Dohme Corp.600
未知
不适用
A 66-WEEK EXTENSION TO: A PHASE IIB, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGE FINDING CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF MK-3102 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INADEQUATE GLYCEMIC CONTROPER-062-11MERCK SHARP & DOHME PERU S.R.L.,