|Table of Contents|
Initiation of insulin glargine plus oral antidiabetic drugs in patients with type 2 diabetes uncontrolled on premixed insulin
Glycaemic control is fundamental in the management of diabetes. The primary objective of this study was to evaluate the effectiveness of insulin glargine administered in combination with oral antidiabetic drugs (OADs) in patients with type 2 diabetes mellitus (T2DM) uncontrolled on pre-mixed insulin-based therapy in the United Arab Emirates, Oman and Kuwait. The secondary objectives were to observe the proportion of patients achieving the targeted glycated haemoglobin (HbA1c) level of <7% and to describe the safety profile. In this 16-week non-interventional, prospective, multicentre, non-comparative, post-authorization study, we included adults with T2DM who failed to achieve HbA1c <7% after 3–12 months on pre-mixed insulin-based therapy and whose physician had decided (at his or her discretion) to switch the patient’s treatment to basal insulin plus OADs with insulin glargine (one injection), or a basal insulin plus insulin glargine (one injection) and one injection of short-acting insulin regimen. Change in HbA1c and fasting blood glucose (FBG) at 16 weeks, and the proportion of patients achieving HbA1c <7% at 16 weeks were evaluated. Safety was assessed by occurrence of adverse events, primarily hypoglycaemia. Out of 397 patients enrolled, 375 were analysed and 361 were included in the study population. In the study population, the mean reduction in HbA1c and FBG from baseline to the end point was 1.60% [standard deviation (SD) ±1.07%] (P<0.001) and 76.26 (SD ±57.00) mg/dl] (P<0.001), respectively, corresponding to a 23% and 34% relative reduction, respectively. The percentage of patients achieving HbA1c level <7% was significantly higher at 16 weeks than at 4 weeks (42.7% vs. 7.6%). A total of 24 patients (6.04%) reported hypoglycaemia at the 16-week visit. A significant mean reduction in HbA1c and FBG levels (P<0.001) was observed among the treatment subgroups (insulin glargine alone and insulin glargine+short-acting insulin). In this observational study, initiation of insulin glargine plus OADs in patients with T2DM who failed to achieve glycaemic control on pre-mixed insulin led to significant overall improvements in HbA1c and FBG levels.