NCT01005069

Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus

Phase-II Clinical Study: A Randomized, Double Blind, Dose Ranging, and Controlled Study to Evaluate the Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	DLBS-32	DLBS-32 50 mg once daily and lifestyle modification
DRUG	DLBS-32	DLBS-32 100 mg once daily and lifestyle modification
DRUG	DLBS-32	DLBS-32 200 mg once daily and lifestyle modification
DRUG	DLBS-32	DLBS-32 300 mg once daily and lifestyle modification
DRUG	Placebo capsule	Placebo capsules once daily and lifestyle modification

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2009-10-30
• Last updated: 2010-09-28

Locations

2 sites across 1 country: Indonesia