MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformain (Alone or in Combination with Insulin)

Phase 1

Active, not recruiting

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-004035-23-BG
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-22
• Study Completion: 2019-09-17
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 223

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified