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

Type-2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472614
• Other study ID #: DLBS3233-0411
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2011
• Last updated: May 24, 2013
• Start date: September 2011
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Dexa Medica Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type-2 Diabetes Mellitus

Intervention

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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of A1c level	Reduction of A1c level from baseline after 12 weeks of treatment	12 weeks	No
Secondary	Reduction of venous A1c level	Reduction of venous A1c level from baseline to 6 weeks of treatment	6 weeks	No
Secondary	Reduction of venous FPG	Reduction of venous FPG from baseline to every evaluation-time point	6 and 12 weeks	No
Secondary	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	No
Secondary	Change in fasting insulin level	Change in fasting insulin level from baseline to every evaluation-time point	6 and 12 weeks	No
Secondary	Change in HOMA-R	Change in HOMA-R from baseline to every evaluation-time point	6 and 12 weeks	No
Secondary	Change in HOMA-B	Change in HOMA-B from baseline to every evaluation-time point	6 and 12 weeks	No
Secondary	Change in adiponectin level	Change in adiponectin level from baseline to every evaluation-time point	6 and 12 weeks	No
Secondary	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	No
Secondary	Change in body weight	Change in body weight from baseline to every evaluation-time point	6 and 12 weeks	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes