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

Abstract

<b>OBJECTIVE </b> <p><b>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</b><b> </b><b>inadequate glycemic control. </b></p> <p><b>RESEARCH DESIGN AND METHODS</b> </p> <p><b>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. </b><b></b></p> <p><b>RESULTS</b></p> <p><b>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</b><b>). 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. </b><b></b></p> <p><b>CONCLUSIONS</b> </p> <p><b>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.</b><b></b></p>

Transitioning from basal–bolus or premix insulin therapy to a combination of basal insulin and glucagon‐like peptide‐1 receptor agonist in people with type 2 diabetes

“…The search terms are presented in Table S1. The search results were discussed by the author group and relevant articles were identified; 19–33 these are summarised in Tables 1 and 2 19–33 …”

“…The search terms are presented in Table S1. The search results were discussed by the author group and relevant articles were identified; [19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] these are summarised in Tables 1 and 2. [19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]…”

“…In the 6‐month, randomised, open‐label BEYOND trial, 305 older adults (>35 years) with type 2 diabetes and HbA1c > 58 mmol/mol (7.5%), on BBI, were transitioned to either further intensified BBI ( n = 101), an FRC of basal insulin plus GLP‐1RA ( n = 102) or basal insulin plus SGLT2i ( n = 102) 31 . In the subgroup switching from BBI to IDegLira or IGlarLixi, significant reductions were observed from baseline to end of study in mean HbA1c (−0.6%; p < 0.001), FPG (−24 mg/dl; p < 0.001), body weight (−1.9 kg; p = 0.001) and total insulin dose (−27.1 U/day; p < 0.001) ( Table 1 ) .…”

Expert Panel Guidance and Narrative Review of Treatment Simplification of Complex Insulin Regimens to Improve Outcomes in Type 2 Diabetes

“…Simplification can also be achieved by use of OADs, as shown in the BEYOND trial [52]. The trial evaluated the feasibility of switching individuals with inadequate glycaemic control from a basal-bolus regimen to an FRC of basal insulin with a GLP-1 RA, or a sodium-glucose co-transporter 2 inhibitor (SGLT2i).…”

One‐year safety and efficacy results of insulin treatment simplification with IDegLira in type 2 diabetes

“…[8][9][10] Until recently, only few trials dealt with hypoglycaemic medication simplification and examined the outcomes of different deintensification regimens. [11][12][13] Evidence-based strategies for simplifying multiple daily insulin injection (MDI) treatment in overtreated people with type 2 diabetes mellitus are still lacking.…”