MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformai
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-004035-23-IT
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
1. Subject has type 2 diabetes mellitus
2. Subject has an A1C =7.0% 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 6 months 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: 240
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 ketonuria requiring immediate initiation of another antihyperglycemic agent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In pediatric subjects with inadequate control on metformin therapy, after 20 weeks:<br>1. To asses)s the effect of the addition of sitagliptin (MK-0431A XR) compared with the addition of placebo on A1C <br>2. To assess the safety and tolerability of the addition of sitagliptin (MK-0431A XR;Secondary Objective: In pediatric subjects with inadequate control on metformin therapy, after 20 weeks:<br>1. To assess the effect of the addition of sitagliptin (MK-0431A XR) compared with the addition of placebo on FPG, proportion of subjects initiating rescue, proportion of subjects with A1C at goal.<br>;Primary end point(s): A1C;Timepoint(s) of evaluation of this end point: 20 Weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Fasting plasma glucose, proportion of subjects initiating glycemic rescue, proportion of subjects with A1C at goal;Timepoint(s) of evaluation of this end point: 20 Weeks