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

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

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.

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.

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