Impact of Insulin Therapy Assistance Program, a Patient Support Program, on 10,426 Indian T2DM Patients to Assess Safety and Efficacy with Biosimilar Insulin

Abstract

Introduction: Insulin Therapy Assistance Program (iTAP) is a structured Patient Support Program (PSP) designed by Biocon for T2DM patients receiving insulin therapy. The contact program trained the patients on essentials of diabetes, life style management including diet, importance of exercise and general care by trained and certified health care providers. The aim of this study is to understand efficacy and safety of insulin (Biosimilar) treatment in patients with T2DM with PSP. Method: A total of 10,426 patients were enrolled over a four-year period. These patients were observed at 3, 6 and 9 months post-initiation. This study presents the improvements in the glycaemic parameters—blood glucose, glycated haemoglobin (HbA1c) and body weight in patients on insulin therapy over 9 months follow-up period. Patients in the PSP received either human insulin (Insugen) or basal insulin (Basalog). The mean blood glucose, glycated haemoglobin and body weight were analysed for any differences with respect to the type of insulin. Results: The mean (SD) blood glucose (mg%) significantly reduced (p<0.05) with insulin initiation from 183.78 (54.74) at baseline to 145.15 (33.79) at 3 months and 132.80 (29.38) at 6 months and 133.98 (25.13) at 9 months. Similarly, the HbA1c reduced (p<0.05) from 10.10% (1.75) at baseline to 7.85% (1.06) at the end of 9 months. Minimal changes were observed in the bodyweight. Conclusion: It was observed with iTAP, there was an overall significant improvement in the glycaemic parameters when therapy was aided with a PSP. Insulin therapy in this study proved to be safe and well tolerated in patients with T2DM. The preponderance of evidence that is glycaemic control and low risk of hypoglycaemia suggest a positive impact of PSP on clinical outcomes which aid patients stand to benefit from participation. Disclosure S. Jabeen: Employee; Self; Biocon. D. Pawar: Employee; Self; Biocon. S. Vs: Employee; Self; Biocon. P. Raj: Employee; Self; Biocon.