A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK8245 in Patients With Type 2 Diabetes Mellitus With 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4月14日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方

研究概览入排标准研究者记录与标识符相似试验

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 65（—）

入选标准

•The patient has type 2 diabetes mellitus (T2DM).
•The patient´s age is> 18 and <65 years on the day of the signing of the informed consent.
•The patient has a body mass index (BMI)> 27 kg / m2 and <43 kg / m2.
•The patient never received a drug before or currently does not receive AHA (without AHA for> 12 weeks), and on Visit 1 / Selection Visit has AIC> 7% and <10%
•The patient is a male or female person without reproductive potential.
•The patient understands the study procedures, the available alternative treatments and the risks involved in the study, and agrees to participate voluntarily by giving written informed consent.
•The patient has an FPG> 130 mg / dL (7.2 mmol / L) and <260 ing / dL (14.4 mmol / L).
•The patient has a compliance> 85% with respect to the study drug during the transition with placebo in simple blind (as determined by capsule count).
•The patient complies with the diet and exercises during the transition period.
•The patient has successfully completed the 24-hour home procedures, which include consuming> 50% of each meal based on caloric content.

排除标准

•The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or the patient is being evaluated by the investigator as a possible patient with type 1 diabetes confirmed with a C-peptide value <0.7 ng / mL (<0.23 nmol / L) .
•The patient has been treated with a PPARy agent (ie, TZD [pioglitazone or rosiglitazone]) or with insulin therapy in the last 12 weeks.
•The patient has been treated with lipid-lowering drugs, such as statins (ie, HMG-CoA reductases [eg, simvastatin, atorvastatin]), fibrates (for example, gemfibrozil, fenofibrate), czetimibe, niacin, or sequestrants of bile acids within the previous 4 weeks.
•The patient has been in a weight reduction program and is not in the maintenance phase, or the patient started with weight loss drugs (for example, orlistat, rimonabant, sibutramine, etc.) within the last 12 weeks
•The patient is being treated with immunosuppressive or immunomodulatory agents (for example, methotrexate, cyclosporine, etanercept), or the patient is receiving treatment with pharmacological doses of corticosteroidcs - or will probably need such treatment or receive physiological replacement therapy with oral corticostcroids (it is say, a patient with adrenal insufficiency).
•The patient is currently participating in a study, or has participated in a study with or without a compound or device under investigation within 12 weeks prior to signing the informed consent.
•The patient has undergone a surgical procedure within a period of 30 days prior to the signing of the informed consent, or plans to undergo major surgery.
•The patient has a medical history of active liver disease (other than non-alcoholic liver steatosis), including chronic active hepatitis B or C (evaluated by medical history), cirrhosis or symptomatic gallbladder disease.
•The patient has a history of coronary heart disease or congestive heart failure.
•The patient suffered a stroke or a transient ischemic neurological disorder during the last 6 months.
•The patient suffers from severe peripheral vascular disease (for example, manifested by claudication with minimal activity, ischemic ulcer with difficulty healing, or a disease that will probably need intervention, such as a coronary bypass or an angioplasty).
•The patient has a systolic blood pressure> 160 mm Hg or diastolic blood pressure> 90 mm Hg and the blood pressure is not considered likely to decrease below these limits at Visit 3 / Week 2 with an adjustment in the antihypertensive drug.
•The patient is HIV positive (as assessed by the medical history).
•The patient is currently being treated for hyperthyroidism.
•The patient suffers from a clinically important hematologic disorder (for example, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
•The patient has a history of malignant disease <5 years before the signing of the informed consent, except for basal or squamous cell skin cancer or cervical cancer in situ that were satisfactorily treated. A patient with a history of malignant disease> 5 years before signing informed consent should not present evidence of disease.
•The patient has a history of macular edema or vitreous hemorrhage.
•The patient has a recent history (ie, in the last 2 weeks) of eye infection or other inflammatory eye or conjunctive condition, including uveitis or scleritis.
•The patient has a history of wearing conta

研究者

发起方

MERCK SHARP & DOHME PERU S.R.L.,

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