A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 18, 2012

Primary Completion Date

April 29, 2014

Study Completion Date

April 29, 2014

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sitagliptin/metformin XR

Fixed dose combination tablet of immediate-release sitagliptin 50 mg and extended-release (XR) metformin 1000 mg (total daily dose, sitagliptin 100 mg and metformin XR 2000 mg).

DRUG

Placebo

Matching placebo to fixed dose combination tablet of sitagliptin and metformin. Matching placebo tablets are same size, shape and color as the active product, but do not contain any markings.

DRUG

Metformin

Concomitant use of metformin is permitted during the study provided the participant has been receiving a stable metformin dose for at least 12 weeks prior to the dose of study drug. Administration of metformin will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.

DRUG

Thyroid hormone

Concomitant use of thyroid hormone (eg, levothyroxine) is permitted during the study provided the participant has been receiving a stable dose for at least 12 weeks prior to study drug administration and is euthyroid as documented by thyroid stimulating hormone testing at prestudy. Administration of thyroid hormone will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01557504 - A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296) | Biotech Hunter | Biotech Hunter