Type 2 Diabetes Mellitus
Conditions
Interventions
MK-0431A-170-04
Drug: Metformin
Drug: Sitagliptin + Metformin FDC
Drug: Placebo to Metformin
Drug: Placebo to Sitagliptin + Metformin FDC
Biological: Insulin
Biological: Insulin glargine
MK-0431A (
850 mg
or 1000 mg) and one tablet of MK-0431A placebo (matching the metformin dose), administered twice daily prior to the morning ane evening meals. During the 20-week double-blind treatment period, patient
Sponsors
Merck Sharp and Dohme Corp
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects between the age of 10 to 17 years on day of signing informed consent with randomization to occur prior to 18th birthday. 2. Diagnosed Type 2 Diabetes Mellitus (T2DM) 3. Patient on metformin monotherapy (?1500 mg/day, for ?12 weeks) with A1C ?6.5% and ?10.0% OR Patients is on stable doses 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 prior to Screening Visit/ Visit 1) with an A1C?7.0% and 10%. 4. HbA1C greater than or equal to 6.5% and less than or equal to 10.0% on metformin, greater than or equal to 1500 mg/day, for greater than or equal to 12 weeks. (Participants on a daily dose of metformin greater than or equal to 1000 mg/day, but less than 1500 mg/day may be eligible if there is documentation that higher doses are not tolerated). 5. Participant has a family member or adult closely involved in the daily activities.
Exclusion criteria
Exclusion criteria: Additional clarity given through Specific Treatments: 1.Patient has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide). Note: Patients who have participated in single-dose studies with these agents at least 12 weeks prior to screening are eligible to participate. 2. Patient has initiated chronic treatment with a medication known to cause: a. weight gain within 30 days of Visit 1 or b. weight loss (such as orlistat) or c. increase blood glucose within 8 weeks of Visit 1. Note: Patients on a weight loss program and not in the maintenance phase, or who have undergone bariatric surgery within 12 months prior to signing the informed consent will be excluded. Note: Patients who have been treated with an anti-psychotic agent within the past 12 weeks will be excluded. 3. Patient is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks of signing the informed consent (including patients who have participated in single-dose studies with these agents) and does not agree to refrain from participating in any other study while participating in this study. Note: A patient who has participated in a non-interventional or placebo study may be enrolled. 4. Patient is on or likely to require treatment with ?14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. Note: Inhaled, nasal, and topical corticosteroids are permitted. 5. Patient has undergone a surgical procedure within the prior 4 weeks or has major surgery planned during the study. Note: Patients who have undergone minor surgery within the prior 4 weeks and are fully recovered or patients who have planned minor surgery may participate. Minor surgery is defined as a surgical procedure involving local anesthesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (A1C) [At baseline and at the completion of 20 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change from baseline in FPG at Week 20 2) Percentage of patients with A1C at goal (<7.0% as primary; <6.5% as secondary) at Week 20 3) Percentage of patients initiating glycemic rescue therapy at Week 20 4) Percentages of patients with symptomatic hypoglycemia 5) Percentages of patients with symptomatic GI events (i.e., nausea, vomiting, abdominal pain or discomfort, and diarrhea) [At baseline and at the completion of 20 weeks] | — |
Countries
Argentina,Bulgaria,Canada,Chile,Colombia,Costa Rica,Dominican Republic,Germany,Guatemala,Israel,Italy,Malaysia,Mexico,New Zealand,Romania,Russian Federation,Saudi Arabia,Sri Lanka,Thailand,United Arab
Contacts
Public ContactDr. Noel Somasundaram
Consultant Endocrinologist
Outcome results
None listed