Randomized Sitagliptin Withdrawal Study (MK-0431-845)

PHASE3CompletedINTERVENTIONAL
Enrollment

746

Participants

Timeline

Start Date

May 9, 2016

Primary Completion Date

January 22, 2018

Study Completion Date

January 30, 2018

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sitagliptin

Sitagliptin 100 mg, oral, once daily for 30 weeks

DRUG

Placebo to sitagliptin

Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks

DRUG

Metformin

At least 1500 mg/day, oral, twice daily for participants entering the study on immediate-release metformin + sitagliptin or a fixed dose combination (FDC).

DRUG

Metformin XR

At least 1500 mg/day, oral, once daily for participants entering the study on extended-release metformin + sitagliptin or a FDC.

DRUG

Insulin glargine

Insulin glargine (LANTUS®) initiated at 10 units and titrated based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L); administered once daily subcutaneously.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02738879 - Randomized Sitagliptin Withdrawal Study (MK-0431-845) | Biotech Hunter | Biotech Hunter