Feasibility of Simplification From a Basal-Bolus Insulin Regimen to a Fixed-Ratio Formulation of Basal Insulin Plus a GLP-1RA or to Basal Insulin Plus an SGLT2 Inhibitor: BEYOND, a Randomized, Pragmatic Trial
BEYOND trial evaluated the feasibility of either basal insulin + GLP-1RA (glucagon-like peptide-1 receptor agonist), or basal insulin + SGLT-2i (sodium-glucose cotransporter-2 inhibitor) to replace a full basal-bolus insulin (BBI) regimen in participants with type 2 diabetes and inadequate glycemic control.
RESEARCH DESIGN AND METHODS
Participants were randomized (1:1:1) to: a) intensification of the BBI regimen (n = 101), b) fixed-ratio of basal insulin + GLP-1RA (fixed-combo group, n = 102), and c) combination of basal insulin + SGLT-2i (gliflo-combo group, n = 102). The primary efficacy outcome was change from baseline in HbA1c at 6 months.
RESULTS
Baseline characteristics were similar among the 3 groups (mean HbA1c was 8.6%, 70 mmol/mol). At 6 months, patients experienced similar reduction in HbA1c level (-0.6 ± 0.8, -0.6 ± 0.8, -0.7 ± 0.9%, mean ± SD, respectively, noninferiority P < 0.001 vs BBI) and the proportion of patients with HbA1c ≤7.5% was also similar (34%, 28% and 27%, respectively, P = 0.489). Total insulin dose increased in BBI group (62 U/day), and decreased both in the fixed-combo and gliflo-combo groups (27 U and 21 U/day, respectively, P <0.01). The proportion of patients with hypoglycemia was 17.8%, 7.8% and 5.9%, respectively (P = 0.015). There were 12 drop-outs in the fixed-combo group, 9 in the gliflo-combo group and none in the BBI group.
CONCLUSIONS
BEYOND provides evidence that it is possible and safe to switch from a BBI regimen to either a once daily fixed-combo injection or once daily gliflozin added to basal insulin, with similar glucose control, less insulin doses, less injections daily, and less hypoglycemia.
