A Phase III Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A XR (a Fixed-Dose Combination Tablet of Sitagliptin and Extended-Release Metformin) in Pediatric Subjects with Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy - MK-0431A XR in Pediatric Patients with T2DM and Inadequate Glycemic Control on Metformain

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 90 人开始时间: 2015年8月7日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•1. Subject has type 2 diabetes mellitus
•2. Subject has an A1C =6.5% and =10.0% on a stable dose of metformin IR or XR (=1500 mg/day) for =12 weeks before Visit 1
•3. Subject is between 10 and 17 years of age (inclusive) on day of signing informed consent with randomization to occur prior to the subject’s 18th birthday
•4. Subject has not received treatment with insulin for at least 12 weeks prior to the Screening Visit/Visit 1
•5. Patient is either a male, or patient is a female who is unlikely to conceive as indicated by at least one yes” response to the following which will remain consistent for the projected duration of the study and for 14 days after the last dose of study medication: (a) Patient is a non-sterilized female who is currently not sexually active and agrees to follow statement c if heterosexual activity is initiated or (b) Patient agrees to abstain from heterosexual activity or (c) Patient agrees to use an adequate method of contraception.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 90
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Subject has known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies, or known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
•2. Subject has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, saxagliptin, or linagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide)
•3. Subject has symptomatic hyperglycemia and/or moderate to large ketonuria and/or positive test for ketonemia, requiring immediate initiation of another antihyperglycemic agent.

发起方