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

Abstract

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.