Clinical trial NCT01472614: Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus
Official title: Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type-2 Diabetes Mellitus
Keywords: Type-2 diabetes mellitus
Add-on therapy
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of A1c level
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction of venous A1c level
timeFrame: 6 weeks
measure: Reduction of venous FPG
timeFrame: 6 and 12 weeks
measure: Reduction of venous 1h-PG
timeFrame: 6 and 12 weeks
measure: Change in fasting insulin level
timeFrame: 6 and 12 weeks
measure: Change in HOMA-R
timeFrame: 6 and 12 weeks
measure: Change in HOMA-B
timeFrame: 6 and 12 weeks
measure: Change in adiponectin level
timeFrame: 6 and 12 weeks
measure: Change in lipid profile
timeFrame: 6 and 12 weeks
measure: Change in body weight
timeFrame: 6 and 12 weeks
measure: Hematology
timeFrame: 6 and 12 weeks
measure: Liver function
timeFrame: 6 and 12 weeks
measure: Renal function
timeFrame: 6 and 12 weeks
measure: Adverse events
timeFrame: 1-12 weeks
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Private Clinic at Jl. Prof. Dr. Moestopo 164
state: East Java
city: Surabaya
country: Indonesia
facility: Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital
state: East Java
Study officials:
affiliation: Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital
name: Askandar Tjokroprawiro, Prof.Dr.dr,SpPD-KEMD,FINASIM
role: PRINCIPAL_INVESTIGATOR
References: