Trial | NCT01531933  Report issue

Title

Efficacy and Safety of DLBS3233 in Prediabetic Patients
Phase III Clinical Study : DLBS3233 in Primary Prevention of Type 2 Diabetes Mellitus [DIPPER-DM]

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dlbs3233 ...

  • Study Participants

    80
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.
There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 for 12 weeks of therapy.

Subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. All subjects will be advised to follow such a lifestyle modification throughout the study period.

All subjects will be under direct supervision of a medical doctor during the study period.

All clinical and laboratory examinations to evaluate the investigational drug's efficacy, will be performed at baseline, Week 8th and Week 12th (end) of study treatment. Blood glucose level (both FPG and 2h-PG) will be performed at baseline and at interval of 4 weeks over the 12 weeks of study treatment. Safety examinations will be performed at baseline and at the end of study. Occurrence of adverse event will be observed during the study.
Study Started
Nov 30
2011
Primary Completion
Jul 31
2012
Study Completion
Jul 31
2012
Last Update
Aug 07
2012
Estimate

Drug DLBS3233

For the first 4 weeks, subjects should take DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.

  • Other names: Inlacin

Drug Placebo of DLBS3233

For the first 4 weeks, subjects should take placebo of DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.

DLBS3233 Experimental

Placebo of DLBS3233 Placebo Comparator

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
No Results Posted