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

Dexa Medica

Status and phase: Completed; Phase 3

Conditions: Type-2 Diabetes Mellitus

Treatments: Drug: DLBS3233

Study type: Interventional

Funder types: Industry

Identifiers

NCT01472614

DLBS3233-0411

Details and patient eligibility

About

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.

Full 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 intensification (lifestyle modification), and DLBS3233 at a dose of 100 mg once daily for 12 weeks.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at interval of 6 weeks over the 12-week course of therapy.

Enrollment: 54 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

DLBS3233

Experimental group

Treatment:

Drug: DLBS3233