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
| العنوان: | 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 |
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| المؤلفون: | Maria Ida Maiorino, Rosa Di Fraia, Paola Caruso, Miriam Longo, Lorenzo Scappaticcio, Michela Petrizzo, Maurizio Gicchino, Katherine Esposito, Giuseppe Bellastella, Dario Giugliano |
| المساهمون: | Giugliano, D., Longo, M., Caruso, P., Di Fraia, R., Scappaticcio, L., Gicchino, M., Petrizzo, M., Bellastella, G., Maiorino, M. I., Esposito, K. |
| المصدر: | Diabetes Care |
| بيانات النشر: | American Diabetes Association, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Blood Glucose, medicine.medical_specialty, Glycated Hemoglobin A, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, 030209 endocrinology & metabolism, Type 2 diabetes, Hypoglycemia, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Glucagon-Like Peptide 1, Internal medicine, Diabetes mellitus, Internal Medicine, Medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, Sodium-Glucose Transporter 2 Inhibitors, Glycemic, Advanced and Specialized Nursing, Glycated Hemoglobin, Hypoglycemic Agent, Emerging Therapies: Drugs and Regimens, business.industry, medicine.disease, Feasibility Studie, Regimen, Endocrinology, Diabetes Mellitus, Type 2, Feasibility Studies, business, Gliflozin, Human, medicine.drug |
| الوصف: | 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 HbA1c at 6 months. RESULTS Baseline characteristics were similar among the three 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, and −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 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. |
| اللغة: | English |
| تدمد: | 1935-5548 0149-5992 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1928bce38e65f8eb35666f88c7cc7b16Test http://europepmc.org/articles/PMC8247516Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....1928bce38e65f8eb35666f88c7cc7b16 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19355548 01495992 |
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