A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170 AM1)
The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin monotherapy.
Diabetes Mellitus, Type 2
Drug: Sitagliptin / Metformin
Drug: Placebo to Metformin
Drug: Placebo to Sitagliptin / Metformin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients With Type 2 Diabetes Mellitus|
- Change from baseline in Hemoglobin A1c (A1C) at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
- Number of participants with adverse events [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Sitagliptin / Metformin
Sitagliptin/metformin: 50/500, 50/850, or 50/1000 mg and placebo to metformin twice daily
Drug: Sitagliptin / Metformin
Sitagliptin / metformin oral tablet 50/500, 50/850, or 50/1000 mg dosed twice daily.
After the single blind 1-week run-in period patients will be randomized to receive sitagliptin/metformin combination: 50/500, 50/850, or 50/1000 mg twice a day plus placebo to metformin or Metformin 500, 850, or 1000 mg twice a day, plus placebo to sitagliptin/metformin combination.
Other Names:Drug: Placebo to Metformin
Matching placebo to Metformin twice a day
Participants randomized to sitagliptin / metformin combination will take matching placebo to metformin twice a day for 20 weeks.
Active Comparator: Metformin
Metformin 500, 850, or 1000 mg and placebo to sitagliptin /metformin twice daily
Metformin oral tablets twice a day
Participants on a metformin daily dose of 1000, 1250, or 1275 mg at screening will be switched to a metformin daily dose of 1000 mg (500 mg twice a day); 1500, 1700, or 1750 mg will be switched to a metformin daily dose of 1700 mg (850 mg twice a day); 2000 mg or more will be switched to a metformin daily dose of 2000 mg (1000 mg twice a day). Once these adjustments are made participants will enter a 1-week single blind run-in followed by a 20-week treatment period. Total treatment with metformin will be 21 weeks.
Other Name: GlucophageDrug: Placebo to Sitagliptin / Metformin
Matching placebo to Sitagliptin / Metformin oral tablet dosed twice daily
During the 1-week single blind run-in all participants will take the matching placebo to sitagliptin/metformin combination twice a day.
Following randomization participants assigned to metformin treatment arm will take the placebo to sitagliptin/metformin combination twice a day for 20 weeks.
|Contact: Toll Free Number||1-888-577-8839|
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