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2009年5月29日

概览

暂无简介。

注册库

who.int

开始日期

2009年5月29日

结束日期

待定

最后更新

2年前

研究类型

Interventional

发起方

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

•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).

•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.

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