A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)

PHASE3CompletedINTERVENTIONAL
Enrollment

508

Participants

Timeline

Start Date

October 17, 2013

Primary Completion Date

May 4, 2015

Study Completion Date

November 12, 2015

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

MK-1293

MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

DRUG

Lantus™

Lantus™ dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

DRUG

Prandial Insulin

Participants will continue their prandial insulin during the study.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02059161 - A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003) | Biotech Hunter | Biotech Hunter