650-P: Safety and Effectiveness of Recombinant Human Insulin Insugen in Real-World Clinical Setting

Abstract

Background: As the burden of diabetes is increasing dramatically, the demand of insulin is also on rise, affordable access to insulin remains a challenge, particularly in Low and Mid income countries. For that reason, recombinant human insulin (rHI) formulations are considered to be effective alternatives to insulin analogues in countries with limited healthcare systems and resources. Continuing patient education and support programmes with rHI are critical role players in improving the access and overall disease management. Objective: This is a non-interventional study to observe the safety and effectiveness of Recombinant Human insulin in a real world population with type 2 (T2DM) diabetes mellitus from Indian perspective. Methodology: Out of 10426 diabetes patients who were enrolled in patient support program i.e “Insulin Therapy Assistance Program (iTAP)”, 5691 patients were initiated with various formulations of rHI (Insugen R, N, 30/70 and 50/50). Insulin therapy was initiated in T2DM patients with A1C > 7%. HbA1c, FPG and PPG values were recorded at baseline and follow up of 3, 6 and 9 months. Results: The Figure 1, 2, 3 depict the baseline and follow up of FBG, PPG and HbA1c respectively. Figure 1. Change in FPG (*p<0.05). Figure 2. Change in PPG (*p<0.05). Figure 3. Change in HbA1c (*p<0.05). Conclusion: In the current study, various formulations of rHI were well tolerated and resulted in significant reduction of HbA1c, FPG and PPG when aided with patient support program. Considering the economic impact of diabetes patients in taking insulins, human insulin become an alternative option in comparison to analogues which are expensive. Early initiation of insulin therapy can prevent or delay diabetes complications. Access to affordable insulin therapy is the key success factor while considering Insulin Therapy. Disclosure P. Raj: Employee; Self; Biocon. P. J: None. D.C. Mathew: None. C. Biswas: None. S. Nethra: None.