Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.

Official Title
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Phase-II Clinical Study: A Randomized, Double Blind, Dose Ranging, and Controlled Study to Evaluate the Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: DLBS-32
* Drug: DLBS-32
* Drug: DLBS-32
* Drug: DLBS-32
* Drug: Placebo capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting capillary blood glucose of 127-249 mg/dL at screening BMI >= 18.5 kg/m^2 or waist circumference of >= 90 cm (male) or >= 80 cm (female) Normal liver function Normal renal function OHA-naive type-II-diabetic patients Exclusion Criteria: Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Uncontrolled hypertension History of or current treatment with insulin Current treatment with systemic corticosteroids or herbal (alternative) medicines History of renal and/or liver disease Pregnant or breast feeding females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment I<br> | Drug: DLBS-32<br>* DLBS-32 50 mg once daily and lifestyle modification<br>|
| Experimental: Treatment II<br> | Drug: DLBS-32<br>* DLBS-32 100 mg once daily and lifestyle modification<br>|
| Experimental: Treatment III<br> | Drug: DLBS-32<br>* DLBS-32 200 mg once daily and lifestyle modification<br>|
| Experimental: Treatment IV<br> | Drug: DLBS-32<br>* DLBS-32 300 mg once daily and lifestyle modification<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo capsule<br>* Placebo capsules once daily and lifestyle modification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of venous Fasting Plasma Glucose from baseline |  | every 2-week interval over 6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of 2h-post-prandial plasma glucose from baseline |  | six weeks | 
| Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline |  | six weeks | 
| Change of high sensitivity C-reactive protein (hs-CRP) from baseline |  | six weeks | 
| Liver Function, Renal Function, Adverse events |  | six weeks | 
| Change in HbA1c from baseline |  | six weeks | 
| Change in lipid profile from baseline |  | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, DLBS-32, fasting plasma glucose, insulin resistance