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 2Lead Sponsor
Dexa Medica GroupStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Diabetes Mellitus, Type 2Intervention/Treatment
dlbs-32 ...Study Participants
72The 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.
DLBS-32 200 mg once daily and lifestyle modification
DLBS-32 300 mg once daily and lifestyle modification
DLBS-32 50 mg once daily and lifestyle modification
DLBS-32 100 mg once daily and lifestyle modification
Placebo capsules once daily and lifestyle modification
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