Evaluation of the Effectiveness and Safety of Basal Based Therapy with Insulin Glargine and Prandial Insulin in Patients with Type 2 Diabetes Poorly Controlled with Premixed Insulin

Abstract

Abstract Introduction. Type 2 diabetes mellitus (T2DM) is a progressive disease, requiring treatment intensification and exogenous insulin therapy in many patients. The aim of the study was to evaluate the effectiveness and safety of insulin glargine in combination with prandial insulin in poorly controlled type 2 patients previously treated with premixed insulin. Methods. A total of 200 type 2 diabetic patients in Macedonia (male 37.5%; female 62.5%, aged 61.1±0.5 years) poorly controlled (HbA1c>7%) were included in this observational multicenter prospective study. Before enrolment, all patients were treated with premixed insulin (88% with 2 and 12% with 3 injections per day, respectively). During the study, patients received once-daily glargine plus pre-prandial short-acting insulin analogues at investigators’ discretion. Primary end-point included percentage of patients achieving HbA1c <7% at study end. In addition, changes in mean HbA1c and fasting plasma glucose (FPG) during the study duration as well as frequency of hypoglycaemic episodes were evaluated. Results. After 9 months of follow-up, 100 patients (50%) achieved target HbA1c <7%. Mean HbA1c decreased from 9.5±1.5% at the beginning to 6.9±0.8% (p<0.001) at study end and mean FPG decreased from 11.0±3.3 mmol/l to 6.1± 0.9 mmol/l (p<0.001). 50.5% of the patients were treated with basal insulin in combination with OADs and 49.5% required addition of one or more prandial insulin injections. No episodes of severe hypoglycaemia were documented. Conclusions. Basal based insulin treatment with insulin glargine alone or in combination with prandial insulin improved glycaemic control in type 2 diabetics previously poorly controlled with premixed insulin with a low risk of hypoglycaemia and weight gain.