Supplemental_Material_revised_cleaned.pdf (358.67 kB)

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

Download (358.67 kB)
figure
posted on 22.04.2021, 16:26 by Dario Giugliano, Miriam Longo, Paola Caruso, Rosa Di Fraia, Lorenzo Scappaticcio, Maurizio Gicchino, Michela Petrizzo, Giuseppe Bellastella, Maria Ida Maiorino, Katherine Esposito
OBJECTIVE

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.

Funding

This study was funded in part by the “Associazione Salute con Stile”, Naples, Italy.

History