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

被引:43
作者
Giugliano, Dario [1 ]
Longo, Miriam [1 ]
Caruso, Paola [1 ]
Di Fraia, Rosa [1 ]
Scappaticcio, Lorenzo [1 ]
Gicchino, Maurizio [2 ]
Petrizzo, Michela [2 ]
Bellastella, Giuseppe [1 ]
Maiorino, Maria Ida [1 ]
Esposito, Katherine [2 ]
机构
[1] Univ Campania Luigi Vanvitelli, Dept Adv Med & Surg Sci, Div Endocrinol & Metab Dis, Naples, Italy
[2] Univ Campania Luigi Vanvitelli, Dept Adv Med & Surg Sci, Diabet Unit, Naples, Italy
关键词
PEPTIDE-1 RECEPTOR AGONIST; GLOBAL ATTITUDES; GLYCEMIC CONTROL; THERAPY; COMBINATION; ADHERENCE; PHYSICIANS; EFFICACY; SAFETY; TRENDS;
D O I
10.2337/dc20-2623
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVE BEYOND trial evaluated the feasibility of either basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1RA) or basal insulin plus sodium-glucose cotransporter 2 inhibitor (SGLT2i) 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: 1) intensification of the BBI regimen (n = 101), 2) fixed ratio of basal insulin plus GLP-1RA (fixed-combo group; n = 102), and 3) combination of basal insulin plus SGLT2i (gliflo-combo group; n = 102). The primary efficacy outcome was change from baseline in HbA(1c) at 6 months. RESULTS Baseline characteristics were similar among the three groups (mean HbA(1c) was 8.6% [70 mmol/mol]). At 6 months, patients experienced similar reduction in HbA(1c) level (-0.6 +/- 0.8, -0.6 +/- 0.8, and -0.7 +/- 0.9%, mean +/- SD, respectively; noninferiority P < 0.001 vs. BBI), and the proportion of patients with HbA(1c) <= 7.5% was also similar (34%, 28%, and 27%, respectively; P = 0.489). Total insulin dose increased in the BBI group (62 units/day) and decreased both in the fixed-combo and gliflo-combo groups (27 units/day and 21 units/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 dropouts 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, fewer insulin doses, fewer injections daily, and less hypoglycemia.
引用
收藏
页码:1353 / 1360
页数:8
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