An initial look form eastern India into the efficacy and safety of glargine U 300-the new ultra long basal insulin

Abstract

Background: Majority of the Type 2 Diabetic (T2D) subjects in the course of the disease require insulin therapy to achieve glycaemic control. Basal insulin supported oral therapy (BOT) has become a common approach for glycaemic control nowadays thus leading to early insulin initiation The newly introduced ultra long acting basal insulin glargine u 300 is a concentrated form of the gold standard basal insulin Glargine u 100 with a different pharmacokinetic and pharmacodynamic profile (PK/PD) with claimed advantages with regards to daylong durability of action and less incidence of hypoglycaemia. Aims and objectives: To evaluate the efficacy, and safety of Glargine U300 when used along with oral anti diabetic agents (OAD) in insulin naive Indian T2D subjects Materials and methods: This is a retrospective real world medical registry based observational study which looked at insulin naive patients initiated on insulin Glargine U 300 over and above standard of care and were followed up for a minimum of 12 weeks. DMT2 subjects presenting with osmotic symptoms or with OAD failure as per Indian Insulin Guidelines and completed the minimum 12 weeks of Glargine U 300 therapy maintaining all data and without requiring rescue doses of prandial insulin, were included. The primary efficacy parameters evaluated at the end of 12 weeks was glycated hemoglobin (HbA1c) along with of fasting plasma glucose (FPG), post prandial plasma glucose (PPPG). Safety was mainly assessed by self-reported hypoglycemia by the patients and weight gain measured at the clinic. Results: A database of 61 patients (34 male and 27 female) was looked into and there was a statistically significant reduction of all glycaemic parameters (p<0.001) and patients reached target HbA1c <7% at 12 weeks. On the safety front, average weight gain was less than a kilogram (0.71+/-0.13 kg) and there were 5 episodes of symptomatic hypoglycaemia and one episode of severe hypoglycaemia and no incidence of nocturnal hypoglycaemia. Severe hypoglycemia was defined as severe cognitive impairment requiring external assistance for recovery. There were no statistically significant changes in creatinine, systolic and diastolic blood pressure values though there was a statistical significant (p=0.042 and p=0.029 respectively) reduction in triglyceride and low density lipoprotein cholesterol. Conclusion: Glargine U300, from this data appears to be safe and effective basal insulin for initial use in insulin naive OAD failure subjects with low risk of hypoglycaemia and insignificant weight gain.