Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus

PHASE4CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

glimepiride + insulin glargine (Amaryl + Lantus)

"* Amaryl® 4 mg at breakfast + Lantus® at dinner~* The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast"

DRUG

glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)

"* Amaryl® M 1/500 mg at breakfast + Amaryl® M 1/500 mg at dinner + Lantus® at dinner~* The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast"

Trial Locations (1)

Unknown

HeeYoung Lee, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Handok Inc.

INDUSTRY

NCT00913367 - Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus | Biotech Hunter | Biotech Hunter