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

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.

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