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

NCT01472614 | Completed Phase 3 DMC

• 1 other identifier: DLBS3233-0411
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Type-2 Diabetes Mellitus

Keywords

Type-2 diabetes mellitus; Add-on therapy

Outcome Measures

Primary Outcomes (1)

• Reduction of A1c level

  Reduction of A1c level from baseline after 12 weeks of treatment

  12 weeks

Secondary Outcomes (13)

• Reduction of venous A1c level

  6 weeks

• Reduction of venous FPG

  6 and 12 weeks

• Reduction of venous 1h-PG

  6 and 12 weeks

• Change in fasting insulin level

  6 and 12 weeks

• Change in HOMA-R

  6 and 12 weeks

Study Arms (1)

DLBS3233

EXPERIMENTAL

Drug: DLBS3233

Interventions

DLBS3233 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)

Also known as: Inlacin

DLBS3233

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (2)

Private Clinic at Jl. Prof. Dr. Moestopo 164

Surabaya, East Java, Indonesia

Location

Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital

Surabaya, East Java, Indonesia

Location

MeSH Terms

Interventions

DLBS3233

Study Officials

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

  Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 16, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

ID (2)