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
Open accessAbstract
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.
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Pramlintide with bolus insulin improves glycemia and weight in persons with type 2 diabetes.
“Use of the amylin analog pramlintide in conjunction with bolus insulin improves both glycemia and weight in persons with T2D.1092,1093”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1093]
The Trial Design describes basal–bolus insulin, basal insulin plus a GLP-1RA, and basal insulin plus an SGLT2 inhibitor; it does not describe pramlintide with bolus insulin. Searches for “pramlintide” and “amylin” found no passage addressing the claimed effects on glycemia and weight. The paper’s findings about other treatments cannot verify this claim. (LLM, conf=0.76)
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Giugliano, D., Longo, M., Caruso, P., Scappaticcio, L., Pontillo, A., Martino, N. D., Porcellini, C., Angelino, S., Caputo, M., Bellastella, G., et al. (2025) · Diabetologia · doi:10.1007/s00125-025-06535-y · Cited by 1 · see citing works
“The BEYOND trial [5, 6] evaluated the feasibility of switching individuals with type 2 diabetes from a full B-B insulin regimen (four injections daily) to a fixed-ratio combination (FRC) of basal insulin plus a glucagon-like peptide-1 receptor agonist (GLP-1RA) or basal insulin plus a…”
Self-citationUsing GLP-1 Agonists or SGLT-2 Inhibitors to Simplify Complex Insulin Regimens
Brett, A. S. (2021) · Journal watch · doi:10.1056/nejm-jw.na53784
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Issues of insulin therapy for type 2 diabetes and ways to solve them
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Management of Older Adults with Diabetes According to the 2023 Guidelinesfor Elderly Diabetes
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2) Goals of the Guidelines for the Treatment of Diabetes in the Elderly 2023
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Use of glucagon-like peptide 1 receptor agonist to sustain patients off basal-bolus insulin regimens
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4. Blood glucose-lowering therapies – Insulin options for type 2 diabetes
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“Panelists concurred that the introduction of oral semaglutide could facilitate the withdrawal of prandial insulin while maintaining glycemic control and enhancing quality of life, a position reinforced by a substantial body of literature [29, 30].”
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“…reported that participants with T2D switching from a full BBI regimen to iGlarLixi or IDegLira achieved better HbA1c targets and less hypoglycemia with reduced insulin doses, for up to 24 months in approximately 50% of the participants, highlighting the long-term effectiveness of FRCs [69, 70].”
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“First, none of the studies, except for Di Loreto et al. (16), have a follow-up >2 years and thus long-term effectiveness is debatable (13 – 15 , 17 – 22).”
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“Fourteen trials involving 6,717 participants con - tributed to the meta-analysis of participants experiencing Included RCTs: [ 13 – [16 ], 26– [ 37, 39 ] at least one trial-defined hypoglycaemic event [ 13 –16 , 26 , 28 –30 , 32, 34 – 38].”
InfluentialElhassan, A., Mohamed, A.-B., Mahgoub, A., Singh, A., & Ali, I. (2026) · Cureus · doi:10.7759/cureus.117614
- Authors
- Giugliano, D., Longo, M., Caruso, P., Di Fraia, R., Scappaticcio, L., Gicchino, M., Petrizzo, M., Bellastella, G., Maiorino, M. I., & Esposito, K.
- Affiliations
- University of Campania "Luigi Vanvitelli" (IT)
- Division of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli,” Naples, Italy
- Corresponding author
- Giugliano, Dario
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2021-04-21
- Volume
- 44
- Issue
- 6
- Pages
- 1353-1360
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC8247516
- OpenAlex
- W3156642031
- Cited by
- 69
- References
- 24
- Citations by year
- 2026: 5 · 2025: 20 · 2024: 17 · 2023: 13 · 2022: 11 · 2021: 3
- FWCI
- 8.20
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- Funders
- Associazione “Salute con Stile” (1.2020)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes, multiple daily insulin injections, GLP-1 receptor agonists, SGLT2 inhibitors, glycemic control, HbA1c, hypoglycemia, insulin dose reduction, treatment switching
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Blood Glucose, Diabetes Mellitus, Type 2, Feasibility Studies, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin
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