Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

Detailed Description
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There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 (with lifestyle modification) for 12 weeks of therapy. Clinical and physical examination to evaluate the efficacy and safety as well as measurement of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and every 6-weeks-interval. Other clinical and laboratory examinations will be performed at baseline and at the end of study.

Official Title
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Role of DLBS3233 in the Treatment of Subjects With New Onset of Type 2 Diabetes Mellitus

Conditions
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Type-2-diabetes Mellitus, New Onset

Intervention / Treatment
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* Drug: Placebo of DLBS3233
* Drug: DLBS3233
* Other: Lifestyle modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects with age of 18-60 years BMI ≥ 18.5 kg/m2 Newly diagnosed (new onset of) type 2 DM subjects, defined as FPG level of ≥ 126 mg/dL or 2h-PG level of ≥ 200 mg/dL or A1c of ≥ 6.5%) FPG ≤ 183 mg/dL Hemoglobin level of ≥ 10.0 g/dL Serum ALT ≤ 2.5 times upper limit of normal Serum creatinine < 1.5 times upper limit of normal Exclusion Criteria: Female of childbearing potential Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg) History of renal and/or liver disease History of or the presence of any clinical evidence of malignancies Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections Current treatment with systemic corticosteroids or herbal (alternative) medicines Participation in any other intervention trial within 30 days prior to Screening

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 |
| --- | --- |
| Placebo Comparator: Treatment I (control)<br>Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification | Drug: Placebo of DLBS3233<br>* Placebo of DLBS3233 once daily for 12 weeks<br>* Other names: Placebo of Inlacin;Other: Lifestyle modification<br>* Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.<br>|
| Experimental: Treatment II<br>100 mg DLBS3233 once daily for 12 weeks + lifestyle modification | Drug: DLBS3233<br>* 100 mg DLBS3233 once daily for 12 weeks<br>* Other names: Inlacin;Other: Lifestyle modification<br>* Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of A1c level | Reduction of A1c level from baseline to Week 12 of treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of venous FPG | Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment | 6 weeks and 12 weeks | 
| Reduction of venous 2h-PG | Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment | 6 weeks and 12 weeks | 
| Response rate | Percentage of subjects with FPG < 110 mg/dL and/or reduction of at least 10% in FPG level from baseline to Week 12 of treatment | 12 weeks | 
| Change in fasting insulin level | Change in fasting insulin level from baseline to Week 12 of treatment | 12 weeks | 
| Change in HOMA-IR | Change in HOMA-IR from baseline to Week 12 of treatment | 12 weeks | 
| Change in HOMA-B | Change in HOMA-B from baseline to Week 12 of treatment | 12 weeks | 
| Change in adiponectin level | Change in adiponectin level from baseline to Week 12 of treatment | 12 weeks | 
| Change in lipid profile | Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment | 12 weeks | 
| Change in body weight | Change in body weight from baseline to Week 6 and Week 12 of treatment | 6 weeks and 12 weeks | 
| Vital signs | Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12 | 6 weeks and 12 weeks | 
| Liver function | Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12 | 12 weeks | 
| Renal function | Renal function (serum creatinine level) will be evaluated at baseline and Week 12 | 12 weeks | 
| Electrocardiography (ECG) | ECG will be evaluated at baseline and Week 12 | 12 weeks | 
| Adverse events | Adverse events as well as number of subjects experienced the events will be observed and evaluated throughout study period (12 weeks) and until all adverse events have been recovered or stabilized | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBS3233, new onset, type-2-diabetes mellitus, oral anti-hyperglycemic agent