Abstract
INTRODUCTION: Combination therapy with both basal insulin (BI) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) is an effective treatment in patients with uncontrolled type 2 diabetes mellitus (T2DM). The recent development and release of a fixed-ratio combination of slow-release insulin degludec and the GLP-1RA liraglutide (IDegLira) represents an improvement to this therapy. We have conducted a real-world evidence study in Italian patients with T2DM to evaluate whether the encouraging clinical trial results obtained with IDegLira, which became available in Italy in January 2018, can be confirmed in Italian clinical practice. METHODS: This was a multicenter, retrospective, observational study in patients with T2DM treated with IDegLira from January to December 2018. Prior to the initiation of IDegLira therapy, patients were treated with BI with or without one or more concomitant oral antidiabetic drugs (BOT group) or according to the basal bolus protocol (BI and rapid-acting insulin treatment; BB group). RESULTS: A total of 244 patients were included in the present study, of whom 186 were in the BOT group and 58 in the BB group. Following the switch to IDegLira therapy, glycemic control improved in both groups, with significant reductions in glycated hemoglobin after 6 and 12 months of treatment in the BOT group and after 6 months of treatment in the BB group. No gain in body weight and body mass index and reductions in fasting plasma glucose and number of concomitant diabetic medications (in BOT patients) were observed. All results obtained during the study were achieved at a moderate dose of IDegLira. CONCLUSION: The findings from this study show that in a real-world setting, the switch to IDegLira treatment is a valid option for patients who are failing to achieve glycemic control targets and/or struggling with the side effects, such as weight gain and hypoglycemia, of other insulin therapies.