Status:
COMPLETED
Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus
Lead Sponsor:
Dexa Medica Group
Conditions:
Type-2 Diabetes Mellitus
Eligibility:
All Genders
40-70 years
Phase:
PHASE3
Brief 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...
Detailed Description
There will only be one group in this study who will receive study treatment as follows: anti-diabetic agents currently used by respective subjects for at least 3 months prior to Screening, treatment i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01472614
Start Date
September 1 2011
End Date
April 1 2013
Last Update
May 27 2013
Active Locations (2)
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1
Private Clinic at Jl. Prof. Dr. Moestopo 164
Surabaya, East Java, Indonesia
2
Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital
Surabaya, East Java, Indonesia