Integration of an educational audio-visual aid with therapeutic evaluation of dapagliflozin and vildagliptin add-on therapy among inadequately controlled type 2 diabetes mellitus patients

Type 2 Diabetes Mellitus is a progressive metabolic disorder, and a significant proportion of patients remain inadequately controlled despite insulin therapy. Intensification of insulin alone is often associated with hypoglycemia, weight gain, and poor adherence. Newer oral hypoglycemic agents such as sodium–glucose cotransporter 2 inhibitors and dipeptidyl peptidase 4 inhibitors provide complementary mechanisms of action and may improve glycemic control without increasing insulin-related adverse effects. This randomized controlled study aims to evaluates the impact of structured medication education on medication knowledge, adherence, quality of life, and clinical outcomes among inadequately controlled T2DM patients on insulin with newly added dapagliflozin 10 mg versus the fixed-dose combination of dapagliflozin 10 mg plus vildagliptin 100 mg. A novel Medication Knowledge Assessment Questionnaire will be developed and validated to assess drug-specific knowledge of newly added therapies. Furthermore, a culturally adapted Medication Educational Audio-Visual Aid in local languages will be developed to enhance patient understanding of these medications. The study addresses critical gaps in evidence regarding head to head comparison of these add on therapies and the role of targeted medication education in insulin-treated inadequately controlled T2DM patients in the Indian population.