Title

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
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    dlbs-32 ...
  • Study Participants

    72
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.
Study Started
Oct 31
2009
Primary Completion
Jul 31
2010
Study Completion
Aug 31
2010
Last Update
Sep 28
2010
Estimate

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

Treatment I Experimental

Treatment II Experimental

Treatment III Experimental

Treatment IV Experimental

Placebo Placebo Comparator

Criteria

Inclusion Criteria:

Fasting capillary blood glucose of 127-249 mg/dL at screening
BMI >= 18.5 kg/m^2 or waist circumference of >= 90 cm (male) or >= 80 cm (female)
Normal liver function
Normal renal function
OHA-naive type-II-diabetic patients

Exclusion Criteria:

Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Uncontrolled hypertension
History of or current treatment with insulin
Current treatment with systemic corticosteroids or herbal (alternative) medicines
History of renal and/or liver disease
Pregnant or breast feeding females
No Results Posted