EUCTR2010-022193-13-FR进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
入选标准
- •- Patient is currently not on an AHA medication (off for =14 weeks) and has a
- •Visit 1/Screening Visit A1C =7.0 and =10.0%.
- •- Patient is currently on oral AHA medication monotherapy or low-dose (i.e., =50%
- •maximum labeled dose of each agent) dual oral combination therapy [except
- •thiazolidinediones (TZDs)] and has a Visit 1/ Screening Visit A1C =6.5 and
- •- Patient has a body mass index (BMI) >20 kg/m2 and <43 kg/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
- •- 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, 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:
- •a. Acute coronary syndrome (such as MI or unstable angina)
- •b. Coronary artery intervention (CABG or PTCA)
- •c. 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
- •- 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
研究者
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