Registry on Monitoring the Effectiveness and Tolerability of Basal (Plus/Bolus) Regimen with Insulin Glargine and Insulin Glulisine in T2 Diabetes Mellitus Patients in Everyday Practice in Saudi

Type 2 Diabetes Mellitus (T2DM) has emerged as a major global health problem and is one of the most common chronic diseases worldwide. The prevalence of T2DM in Kingdom of Saudi Arabia (KSA) population is high (23%) and has increased by 10% in just one decade. Usually addition of basal insulin is considered as the simplest way to start insulin therapy in patients uncontrolled on oral antidiabetic agents (OADs). In KSA, the majority of patients(60%) recommended to use insulin are treated with premixed insulin.Currently there is limited availability of local (KSA) data documenting the switch from premixed insulin to a basal insulin (Plus/Bolus) regimen. To monitor the effectiveness and tolerability of basal (Plus/Bolus) using Insulin glargine and Insuline glulisine in T2DM patients switched from premixed insulin for achieving the glycemic goal (Glycatedhaemoglobin - HbA1c) as targeted by the treating physician. Multicenter, non-interventional prospective product registry was conducted nationwide across KSA. Males and females aged ≥ 21 years, with type 2 diabetes mellitus, uncontrolled on premixed insulin with HbA1C>7 % and Fasting Blood Sugar >120 mg/dL were selected for this study. Changes in HbA1C from baseline to the end of 6 months and the mean number of hypoglycemic episodes experienced by each patient were measured. Out of 619 enrolled patients, 543 patients completed all study visits. There was statistically significant mean change in HbA1c (2.02%) at visit 3 as compared to baseline. Forty-three percent reduction in hypoglycemia incidence (number of patients experiencing at least one hypoglycemic event) and a 30% reduction in event rate from base line till end of 6 months was also seen in this study. In everyday clinical practice, patients with type 2 diabetes inadequately controlled on premixed insulins experienced significant improvements in glycemic control over 24 weeks after switching to a glargine-based insulin regimen. There was also a significantly lower risk of hypoglycemia and a favorable tolerability profile with this regimen. These findings support the use of a basal-bolus glarginebased regimen in T2DM patients poorly controlled on premixed insulins in KSA.