Efficacy and Safety of DLBS3233 in Prediabetic Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Prediabetic
Interventions
DRUG

DLBS3233

For the first 4 weeks, subjects should take DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of \< 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.

DRUG

Placebo of DLBS3233

For the first 4 weeks, subjects should take placebo of DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of \< 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.

Trial Locations (1)

Unknown

Department of Internal Medicine, dr. M. Djamil Padang Hospital, Padang

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Dexa Medica Group

INDUSTRY

NCT01531933 - Efficacy and Safety of DLBS3233 in Prediabetic Patients | Biotech Hunter | Biotech Hunter