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

Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Type-2 Diabetes Mellitus
• Intervention / Treatment: Drug: DLBS3233

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • East Java
    • Surabaya, East Java, Indonesia
      • Private Clinic at Jl. Prof. Dr. Moestopo 164
    • Surabaya, East Java, Indonesia
      • Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DLBS3233	Drug: 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); Other Names: Inlacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of A1c level	Reduction of A1c level from baseline after 12 weeks of treatment	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of venous A1c level	Reduction of venous A1c level from baseline to 6 weeks of treatment	6 weeks
Reduction of venous FPG	Reduction of venous FPG from baseline to every evaluation-time point	6 and 12 weeks
Reduction of venous 1h-PG	Reduction of venous 1 hour-post prandial plasma glucose from baseline to every evaluation-time point	6 and 12 weeks
Change in fasting insulin level	Change in fasting insulin level from baseline to every evaluation-time point	6 and 12 weeks
Change in HOMA-R	Change in HOMA-R from baseline to every evaluation-time point	6 and 12 weeks
Change in HOMA-B	Change in HOMA-B from baseline to every evaluation-time point	6 and 12 weeks
Change in adiponectin level	Change in adiponectin level from baseline to every evaluation-time point	6 and 12 weeks
Change in lipid profile	Change in lipid profile from baseline to every evaluation-time point, including: LDL-cholesterol (direct), HDL-cholesterol, total cholesterol, and triglycerides	6 and 12 weeks
Change in body weight	Change in body weight from baseline to every evaluation-time point	6 and 12 weeks
Hematology	Hematology parameters (Hemoglobin level, Hematocrit, Red Blood Cell count, White Blood Cell count as well as its differentials, and platelet count) will be evaluated at baseline, at interval of 6 weeks, and at the end of study	6 and 12 weeks
Liver function	Liver function parameters (serum ALT, serum AST, gamma-glutamyl transferase, alkaline phosphatase, and total bilirubin levels) will be measured at baseline, at interval of 6 weeks, and at the end of study	6 and 12 weeks
Renal function	Renal function parameter, i.e. serum creatinine level will be measured at baseline, at interval of 6 weeks, and at the end of study	6 and 12 weeks
Adverse events	Adverse events as well as number of subjects experienced the events will be observed and evaluated during the study period (12 weeks) and until all adverse events have been recovered or stabilized.	1-12 weeks

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Askandar Tjokroprawiro, Prof.Dr.dr,SpPD-KEMD,FINASIM, Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: November 11, 2011
• First Submitted That Met QC Criteria: November 11, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): May 27, 2013
• Last Update Submitted That Met QC Criteria: May 24, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Type-2 diabetes mellitus; Add-on therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DLBS3233-0411