PER-019-09已完成未知
A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK-3577 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2009年5月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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 70（—）
入选标准
- •The patient has T2DM.
- •The patient is> 18 and <70 years of age on the day of signing the informed consent form.
- •The patient has not received antihyperglycemic drugs for a minimum of 10 weeks, with an A1C> 6.5% and <9.5%, OR He is receiving a single oral antihyperglycemic drug (but not a PPAR-y agonist), with an A1C> 6.0% and <9.0%, OR You are receiving a combined low dose oral antihyperglycemic drug (but not a PPAR-y agonist) at a dose less than or equal to 50% of the maximum recommended dose (according to the label of each country) of each component, with an A1C> 6.0% and <9.0%.
- •The patient is a man or a woman who is highly unlikely to conceive
- •The patient understands the study procedures, the available alternative treatments and the risks involved in the study, and voluntarily agrees to participate in the study by providing written informed consent.
- •The patient has an FPG> 140 and <240 mg / dL (> 7.8 and <13.3 mmol / L).
- •The patient has> 85% compliance with placebo treatment during the simple blind transition period as measured by the capsule / tablet count carried out at the site.
- •The patient has a glucose obtained by fasting digital puncture at the site <240 mg / dL (<13.3 mmol / L).
排除标准
- •The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
- •The patient has symptomatic hyperglycemia that requires the immediate onset or addition of an antihyperglycemic therapy.
- •The patient has received treatment with a PPAR-y agonist (for example, a thiazolidinedione) within the past 12 weeks.
- •The patient has received insulin treatment within the last 12 weeks.
- •The patient has received treatment with a GLP-1 mimetic or agonist (for example, exenatide) within the last 12 weeks.
- •The patient has previously received treatment with MK-3577.
- •The patient has been treated with a statin therapy (HMG CoA reductase) during the last 12 weeks.
- •The patient is receiving or will likely require treatment with one or more of the prohibited drugs listed in the ´´ Drug Exclusion List ´´ in Appendix 6.1.
- •The patient is in a weight loss program and is not in the maintenance phase, or the patient has received treatment with a weight loss drug
- •The patient has received treatment with an investigational drug within the previous 12 weeks or is participating in another clinical trial.
- •The patient is receiving or probably requires treatment with immunosuppressive / immunomodulatory agents (for example, cyclosporine, methotrexate, etanercept) either the patient is receiving or probably requires treatment with pharmacological doses of corticosteroids.
- •The patient has undergone surgery within 30 days prior to Visit 1 or has major surgery planned.
- •The patient has a history of coronary artery disease
- •The patient has had a stroke or TIA (transient ischemic accident)
- •The patient has a diagnosis of CHF (congestive heart failure) with a Class II - IV heart condition that is established by NYHA (see Appendix 6.2).
- •The patient has a systolic blood pressure> 150 mm Hg or diastolic blood pressure> 85 mm Hg (see Appendix 6.4).
- •The patient suffers from a severe peripheral vascular disease (for example, manifested by claudication with minimal activity, an ischemic ulcer that does not heal, or a disease that probably requires intervention such as bypass or angioplasty during the study).
- •The patient suffers from active liver disease (other than non-alcoholic liver steatosis), active viral hepatitis (Hepatitis B or Chronic Hepatitis C) according to the evaluation of medical history, cirrhosis, Gilbert´s disease or primary biliary cirrhosis.
- •The patient has active nephropathy (ie, nephrotic syndrome or glomerulonephritis).
- •The patient is HIV positive (based on the evaluation of his medical history).
- •The patient has a clinically significant hematologic disorder (for example, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
- •The patient is under medical treatment for hyperthyroidism.
- •The patient has a history of malignancy
研究者
相似试验
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