NCT01645332

Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus

Role of DLBS3233 in the Treatment of Subjects With New Onset of Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

Detailed description

There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 (with lifestyle modification) for 12 weeks of therapy. Clinical and physical examination to evaluate the efficacy and safety as well as measurement of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and every 6-weeks-interval. Other clinical and laboratory examinations will be performed at baseline and at the end of study.

Conditions

• Type-2-diabetes Mellitus
• New Onset

Interventions

Type	Name	Description
DRUG	Placebo of DLBS3233	Placebo of DLBS3233 once daily for 12 weeks
DRUG	DLBS3233	100 mg DLBS3233 once daily for 12 weeks
OTHER	Lifestyle modification	Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2012-07-20
• Last updated: 2014-10-08

Locations

1 site across 1 country: Indonesia