drugset / Trial / NCT01531933

Efficacy and Safety of DLBS3233 in Prediabetic Patients

NCT01531933 ↗

Phase 3 Completed 80 enrolled Dexa Medica Group
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of DLBS3233. It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured by the improvement of prandial (particularly the first phase) insulin secretion as well as insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes into type 2 diabetes mellitus.

Timeline

Start
2011-11
Primary completion
2012-07
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS3233 Traditional medicine (herbal / TCM) 50 mg —
Subject DLBS3233 Traditional medicine (herbal / TCM) 100 mg —

Indications