Efficacy and safety of Insulin Glargine as Basal Therapy in Type 2 Diabetes Mellitus: EASE Study

Background: Type 2 diabetes mellitus (T2DM) is assiocated with increased insulin resistance and an inexorable decline in β-cell function usually requiring intensive treatment to achieve and maintain glycemic control. The aim of the study was to assess the efficacy and safety of insulin glargine (BASALOG®,BIOCON) as a basal regimen in individuals with type 2 diabetes mellitus (T2DM) who are poorly controlled with oral antidiabetic drugs (OADs) and/or other insulins. Methods: This observational, study included 110 adult individuals with T2DM from PANACEA Hospital, Bengaluru. Baseline glycated hemoglobin (HbA1c) ranged between 7.5% and 9.5% and for whom a basal regimen with insulin glargine was initiated. Two follow-up visits were scheduled at 12 and 24 weeks after initating the treatment. The primary outcome target was HbA1c < 7%. Safety was assessed by the frequency of hypoglycemic episodes. Results: The target HbA1c level of < 7% was reached by 16% of patients after 3 months of insulin glargine treatment and 36% after 6 months. Mean HbA1c decreased significantly from 9.25±1.07% at baseline to 7.46±0.92% at 6 months (P < 0.001). Mean fasting blood glucose also decreased significantly from 247.5 ± 55.6 mg/dL at baseline to 129.7 ± 38.1 mg/dL at 6 months (P < 0.001). Approximately 13.6% of patients reported at least one hypoglycemic episode. No adverse events other than hypoglycemia were seen. Conclusions: This study shows that in a realistic setting, a basal regimen with insulin glargine significantly improves glycemic control in patients with T2DM who are inadequately controlled with OADs or other insulin regimens, Hypoglycaemia incidence and rates were as similar during the early and continued treatment periods across all treatment combinations