A real‐world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672)

Summary Aim This is a pre‐post observational study from an endocrinology ambulatory care practice which assessed the effectiveness and safety following the addition of a glucagon‐like peptide‐1 (GLP‐1) agonist, weekly exenatide (Bydureon), to basal insulin therapy in patients with type 2 diabetes mellitus (T2DM). Liraglutide plus basal insulin served as a comparison group. Materials and methods A data collection form was utilized to collect study‐related information. The primary study outcome was change in HbA 1c from baseline to 12 months after GLP‐1 receptor agonist therapy was added to basal insulin therapy. Secondary outcomes were change in weight, percentage of patients achieving an HbA 1c of <7% (53 mmol/mol) or ≤6.5% (48 mmol/mol) and changes in blood pressure and lipid parameters. Safety was assessed by a collection of reported adverse events. Results One‐hundred and fifty patients met inclusion criteria (seventy‐five per treatment arm). After 1 year of therapy, HbA 1c decreased by 0.7% in the entire cohort (once‐weekly exenatide: −0.7%; once‐daily liraglutide: −0.8%; no significant between‐group difference). More subjects in the weekly exenatide arm achieved an HbA 1c  < 7% (53 mmol/mol) ( P  = .03), but a comparable number achieved an HbA 1c  ≤ 6.5% (48 mmol/mol). Although significantly more patients achieved an HbA 1c  < 7% (53 mmol/mol) in the once‐weekly exenatide arm, the baseline HbA 1c was lower (7.9%) than the liraglutide arm (8.4%). No significant differences were observed between groups for other secondary outcomes. A similar number of subjects discontinued therapy, mainly due to gastrointestinal‐ill effects, and hypoglycaemia incidence did not increase compared with the previous year. Conclusion The addition of once‐weekly exenatide to basal insulin was associated with appreciable reductions in HbA 1c and weight without an increase in hypoglycaemia.