Efficacy and Safety of DLBS3233 in Prediabetic Patients
Condition: Prediabetic
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): DLBS3233; Placebo of DLBS3233
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Inlacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prediabetic; Primary prevention; Type 2 diabetes mellitus