New Onset Clinical Trial
Official title:
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment