A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289)

PHASE3CompletedINTERVENTIONAL
Enrollment

223

Participants

Timeline

Start Date

December 7, 2011

Primary Completion Date

September 17, 2019

Study Completion Date

September 17, 2019

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sitagliptin plus metformin

Participants received 2 tablets daily, one taken with a morning meal and one taken with an evening meal, to provide a total daily dose of 100 mg of sitagliptin and 1000 mg, 1700 mg or 2000 mg of metformin. Dosage of metformin was based on each participant's daily metformin dose prior to enrollment.

DRUG

Placebo to metformin

Participants received 2 tablets daily, one taken with a morning meal and one taken with an evening meal. Each tablet contained placebo to metformin.

DRUG

Metformin

Participants received 2 tablets daily, one taken with a morning meal and one taken with an evening meal, to provide a total daily dose of 1000 mg, 1700 mg or 2000 mg of metformin. Dosage was based on each participant's daily metformin dose prior to enrollment.

DRUG

Placebo to sitagliptin plus metformin

Participants received 2 tablets daily, one taken with a morning meal and one taken with an evening meal. Each tablet contained placebo to sitagliptin plus metformin.

DRUG

Sitagliptin plus metformin XR

Participants received 2 tablets daily, both taken together with a meal, to provide a total daily dose of 100 mg of sitagliptin and 1000 mg, 1500 mg or 2000 mg of metformin. Dosage of metformin XR was based on each participant's daily metformin dose prior to enrollment.

DRUG

Placebo to metformin XR

Participants received 2 tablets daily, both taken together with a meal. Each tablet contained placebo to metformin XR.

DRUG

Insulin

"Participants who met protocol-specific glycemic rescue criteria received insulin as glycemic rescue therapy; participants on background insulin had their insulin dose increased for glycemic rescue. During Weeks 20-54, for participants who were not on background insulin or rescued with insulin during Weeks 0-20 in the Sitagliptin/Metformin and Metformin arms (protocol MK-0431A-170), and during Weeks 0-54 for participants not on background insulin in the Sitagliptin/Metformin XR and Metformin XR arms (protocol MK-0431A-289), the type of insulin for glycemic rescue was specified to be insulin glargine."

DRUG

Placebo to sitagliptin plus metformin XR

Participants received 2 tablets daily, both taken together with a meal. Each tablet contained placebo to sitagliptin plus metformin XR.

DRUG

Metformin XR

Participants received 2 tablets daily, both taken together with a meal, to provide a total daily dose of 1000 mg, 1500 mg or 2000 mg of metformin XR. Dosage was based on each participant's daily metformin dose prior to enrollment.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01760447 - A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289) | Biotech Hunter | Biotech Hunter