Type-2 Diabetes Mellitus Clinical Trial
Official title:
Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus
This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus.
There will only be one group in this study who will receive study treatment as follows:
anti-diabetic agents currently used by respective subjects for at least 3 months prior to
Screening, treatment intensification (lifestyle modification), and DLBS3233 at a dose of 100
mg once daily for 12 weeks.
Clinical and laboratory examinations to evaluate the investigational drug's efficacy and
safety will be performed at baseline and at interval of 6 weeks over the 12-week course of
therapy.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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