Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)
Summary
BEYOND represents an open-label, parallel, three-arm randomized controlled trial, aimed at evaluating the effects of combination therapy of fixed ratio basal insulin/GLP-1 receptor agonist (GLP-1RA) or basal insulin/SGLT-2 inhibitors (SGLT-2i) on the durability of the glycemic control, as compared with the basal bolus insulin regimen, in people with type 2 diabetes failing to achieve glycemic targets with injective therapy. The potential benefits for participants in the study include the possibility of improving the glyco-metabolic control with drugs that have been evaluated as safe and protective for the heart and the kidneys. The primary outcome of the study is the mean HbA1c change between groups at six months. Participants in the study will be followed for subsequent 18 months in order to evaluate the durability of glycemic control and the chenge of other secondary outcomes.
Timeline
- Start
- 2019-11-27
- Primary completion
- 2020-09-30
- Completion
- 2020-10-20
Publications
- Background Giugliano D, Bellastella G, Maiorino MI, Esposito K. Beyond basal-bolus insulin regimen: Is it still the ultimate chance for therapy in diabetes? Diabetes Res Clin Pract. 2019 Nov;157:107922. doi: 10.1016/j.diabres.2019.107922. Epub 2019 Nov 9. No abstract available.
- Giugliano D, Longo M, Scappaticcio L, Caruso P, Gicchino M, Petrizzo M, Bellastella G, Maiorino MI, Esposito K. BEYOND 2 years: durability of metabolic benefits by simplification of complex insulin regimens in type 2 diabetes. Endocrine. 2024 Feb;83(2):399-404. doi: 10.1007/s12020-023-03547-9. Epub 2023 Oct 3.
- Giugliano D, Longo M, Caruso P, Di Fraia R, Scappaticcio L, Gicchino M, Petrizzo M, Bellastella G, Maiorino MI, Esposito K. 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. Diabetes Care. 2021 Jun;44(6):1353-1360. doi: 10.2337/dc20-2623. Epub 2021 Apr 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CANAGLIFLOZIN ANHYDROUS | Small molecule | 100 mg | Oral |
| Comparator | CANAGLIFLOZIN ANHYDROUS | Small molecule | 300 mg | Oral |
| Comparator | Dapagliflozin | Small molecule | 10 mg | Oral |
| Comparator | Empagliflozin | Small molecule | 10 mg | Oral |
| Comparator | Empagliflozin | Small molecule | 25 mg | Oral |
| Comparator | IDegLira | Unknown | — | — |
| Comparator | iGlarLixi | Unknown | — | — |
| Comparator | Degludec | Protein / enzyme biologic | — | — |
| Comparator | Insulin Lispro | Protein / enzyme biologic | — | — |
| Comparator | Insulin glulisine | Protein / enzyme biologic | — | — |
| Comparator | insulin aspart | Protein / enzyme biologic | — | — |
| Comparator | insulin glargine | Protein / enzyme biologic | — | — |