The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006)

PHASE3CompletedINTERVENTIONAL
Enrollment

531

Participants

Timeline

Start Date

February 11, 2014

Primary Completion Date

March 11, 2015

Study Completion Date

March 11, 2015

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

MK-1293

MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

DRUG

Lantus™

Lantus™ (insulin glargine \[rDNA origin\]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantus™ at 10 units daily. Participants taking insulin will initiate Lantus™ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

DRUG

Prandial insulin

Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02059187 - The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006) | Biotech Hunter | Biotech Hunter