Assessment of Safety and Effectiveness of Glaritus<sup>®</sup> (Wockhardt’s Insulin Glargine) in a Prospective, Multi-Centric Post Marketing Observational Study in Nepalese Having Type 2 Diabetes Mellitus

Abstract

Background: Nepal is one of the fastest urbanizing countries in South Asia and is facing the consequences of urban lifestyle leading to obesity and metabolic syndrome. Type 2 diabetes mellitus (T2DM) is currently a high-burden disease in Nepal with a prevalence of 8.4%. Of these 8% - 18% patients are on insulin and 42% patients were reported to have uncontrolled diabetes in the past year. This suggests a need for better therapy options in terms of efficacy and safety. The current study was designed to investigate the effects of Insulin glargine-based therapy in Nepalese with T2DM who could not achieve adequate glycemic control with oral and non-glargine-insulin therapy. Methods: This is a prospective, multi-centric, single arm and post marketing observational study to assess the safety and effectiveness of Glaritus® (Wockhardt’s Insulin Glargine) in 52 T2DM patients from 3 (three) different study sites in Nepal (Bharatpur, Kathmandu and Pokhra) from September 2015 to December 2016. The primary objective of the study was to evaluate the safety of Glaritus®, mainly in terms of hypoglycemia, renal function tests and liver function tests. The secondary objectives were to evaluate the effectiveness of Glaritus® in terms of percentage of patients achieving HbA1c goal of less than 7%, mean changes in HbA1c & fasting plasma glucose (FPG) levels from baseline till the end of study. Results: 3.85% of subjects experienced hypoglycemia during first 3 months of therapy whereas 1.92% had similar experience in next 3 months of therapy. The mean HbA1c values reduced from 9.16% to 7.15% at the end of study. 21.05% of the enrolled subjects achieved the goal of HbA1c < 7% at the end of 3 months of therapy, whereas 52.5% achieved the target HbA1c at the end of 6 months of therapy. The mean FPG value of study population reduced from 239.94 mg/dl to 151.31 mg/dl at the end of study. There was no significant change in renal or liver functions during treatment. None of the subjects experienced any other adverse event (AE), thus indicating that Glaritus® was well tolerated by the study patients. Conclusion: In patients with type 2 diabetes mellitus inadequately controlled on oral hypoglycemic agents and/or insulin, initiation with Glaritus® significantly improved glycemic control with good tolerability and acceptability. This analysis in T2DM Nepalese patients shows that by significantly improving glycemic control while not increasing risk of hypoglycemia, Glaritus® provides safer basal insulin and may be suited to aggressive treatment regimens. From a societal perspective, it will help more patients reach the glycemic control target as recommended by the current treatment guidelines.