Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group

Criteria

Inclusion Criteria:

• Male subjects with age of 40 - 70 years; or female subjects with age of 55 - 70 years (post-menopause) at screening

• Diagnosed with type-2 diabetes mellitus

• Have been being treated with a combination of two OHA for at least 3 months prior to screening

• A1c level of >= 7.0 %

• Hemoglobin level of >= 10 g/dL

• Body Mass Index (BMI) > 18.5 kg/m2

• Refuse insulin therapy

• Able to take oral medicine

Exclusion Criteria:

• Subjects with symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

• Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg

• History of or current chronic treatment with insulin

• History of renal and/or liver disease

• Impaired liver function: serum ALT > 2.5 times upper limit of normal and positive result of chronic or acute hepatitis B or C test

• Impaired renal function: serum creatinine >= 1.5 times upper limit of normal

• Current treatment with systemic corticosteroids or herbal (alternative) medicines

• Any other disease state or uncontrolled illness, which judged by the investigator, could interfere with trial participation or trial evaluation

• Participation in any other clinical studies within 30 days prior to screening