Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

February 10, 2012

Primary Completion Date

October 9, 2019

Study Completion Date

October 9, 2019

Conditions
Diabetes MellitusType 2 Diabetes
Interventions
DRUG

Sitagliptin

Sitagliptin 100 mg tablet administered orally once daily

DRUG

Metformin

Metformin 500 mg tablets administered orally starting at 500 mg/day and uptitrated by 500 mg every week to a final dose of 1000 mg twice daily

DRUG

Placebo to sitagliptin

Matching placebo to sitagliptin 100 mg tablet administered orally once daily

DRUG

Placebo to metformin

Matching placebo to metformin 500 mg tablets, 2 tablets administered orally twice daily

DRUG

Glycemic Rescue 1

Participants in the sitagliptin arm who require glycemic rescue will receive metformin during Weeks 0-20 and Weeks 20-54. Participants in the placebo arm who require glycemic rescue will receive metformin during Weeks 0-20. Participants in the placebo arm who have switched to metformin during Weeks 20-54 and require glycemic rescue will receive sitagliptin.

BIOLOGICAL

Glycemic Rescue 2

Participants who require glycemic rescue after Glycemic Rescue 1 will receive open-label insulin. Participants on background insulin therapy will have the dose of their background insulin up-titrated.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01485614 - Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083) | Biotech Hunter | Biotech Hunter