MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus

PHASE3CompletedINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

June 30, 2010

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

MK-0431/ONO-5435

Double-blind period (16 wk); 50 mg QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50mg QD to 100mg QD

DRUG

MK-0431/ONO-5435

Double-blind period (16 wk); placebo QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD

Trial Locations (7)

Unknown

Chugoku Region, Chugoku

Chubu Region, Chūbu

Hokuriku Region, Hokuriku

Kanto Region, Kanto

Kinki Region, Kinki

Kyushu Region, Kyushu

Tohoku Region, Tōhoku

Sponsors
All Listed Sponsors
lead

Ono Pharmaceutical Co. Ltd

INDUSTRY