drugset / Trial / NCT01645332

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

NCT01645332 ↗

Phase 3 Completed 104 enrolled Dexa Medica Group
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2012-07
Primary completion
2014-08
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS3233 Traditional medicine (herbal / TCM) 100 mg —