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

NCT ID: NCT01472614

Last Updated: 2013-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-04-30

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 in subjects with type-2 diabetes mellitus.

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 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.

Conditions

Type-2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DLBS3233

Group Type: EXPERIMENTAL

DLBS3233

Intervention Type: DRUG

Study treatment will be DLBS3233 at a dose of 100 mg once daily (for 12 weeks) in addition to current anti-diabetic treatment used by respective study subjects and treatment intensification (lifestyle modification)

Interventions

DLBS3233

Study treatment will be DLBS3233 at a dose of 100 mg once daily (for 12 weeks) in addition to current anti-diabetic treatment used by respective study subjects and treatment intensification (lifestyle modification)

Intervention Type: DRUG

Other Intervention Names

Inlacin

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Askandar Tjokroprawiro, Prof.Dr.dr,SpPD-KEMD,FINASIM

Role: PRINCIPAL_INVESTIGATOR

Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital

Locations

Private Clinic at Jl. Prof. Dr. Moestopo 164

Surabaya, East Java, Indonesia

Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital

Surabaya, East Java, Indonesia

Countries

Indonesia

Other Identifiers

DLBS3233-0411

Identifier Type: -

Identifier Source: org_study_id