Prediabetic Clinical Trial
Official title:
Phase III Clinical Study : DLBS3233 in Primary Prevention of Type 2 Diabetes Mellitus [DIPPER-DM]
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01887691 -
Sleep Effectiveness and Insulin and Glucose Homeostasis
|
Phase 1 |