Efficacy and Safety of DLBS3233 in Prediabetic Patients

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group

Criteria

Inclusion Criteria:

• Male or female subjects with age of 18-60 years

• Prediabetic patients (2h-PPPG level of 140-199 mg/dL)

• Serum ALT ≤ 2.5 times upper limit of normal

• Serum creatinine < 1.5 times upper limit of normal

• Able to take oral medication

Exclusion Criteria:

• Female of childbearing potential

• History of diabetes mellitus

• History of symptomatic coronary arterial disease, stroke, and cardiovascular events

• Current treatment with systemic corticosteroids or herbal (alternative) medicines

• Any other disease state or uncontrolled illness, which judged by the investigator, could interfere with trial participation or trial evaluation

• Participation in any other clinical studies within 30 days prior to screening