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

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.