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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group

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