EUCTR2012-004035-23-BGActive, not recruitingPhase 1
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 Patients with Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination with Insulin) - MK-0431A XR in Pediatric Patients with T2DM and Inadequate Glycemic Control on Metformain
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as0 sites223 target enrollmentStarted: January 22, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 223
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Subject has type 2 diabetes mellitus
- •2. Subject has an A1C =6.5% and =10.0% at Visit 1 on a stable dose of metformin (=1500 mg/day, for =12 weeks) without insulin.
- •Subject has an A1C =7.0% and =10.0% at Visit 1 on a stable dose of metformin (=1500 mg/day, for =12 weeks) and insulin (of any type, variance in dose to be =15% of total daily dose, for =12 weeks).
- •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. 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.
- •If abstinence is not a locally acceptable method of contraception, then one other adequate birth control method must be used.
- •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
Exclusion Criteria
- •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.
Investigators
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