Evidence map›Paper›PMID 37787888›Full record

Trial reportEndocrine2024

BEYOND 2 years: durability of metabolic benefits by simplification of complex insulin regimens in type 2 diabetes.

Dario Giugliano, Miriam Longo, Lorenzo Scappaticcio, Paola Caruso, Maurizio Gicchino, Michela Petrizzo, Giuseppe Bellastella, Maria Ida Maiorino, Katherine Esposito

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Endocrine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04196231 (Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04196231 phase4completednot on this map

Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes: a Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Campania Luigi VanvitelliRan2019 to 2020Enrolled258ConditionsType 2 DiabetesArmsIDegLira, IGlarLixi, Insulin/Canaglifozin, Insulin/Dapaglifozin, Insulin/Empaglifozin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Use of Fixed Ratio Combinations to Improve Glycemic Control in Individuals with Type 2 Diabetes: Experts' Opinion from the Gulf Region.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
    Review
  3. Observational
  4. Article
  5. Review
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Dario GiuglianoDepartment of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli,", Naples, Italy. dario.giugliano@unicampania.it.ORCID 0000-0002-9377-873X
Miriam LongoDepartment of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli,", Naples, Italy.
Lorenzo ScappaticcioDepartment of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli,", Naples, Italy.
Paola CarusoDepartment of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli,", Naples, Italy.ORCID 0000-0002-4756-2022
Maurizio GicchinoDivision of Endocrinology and Metabolic Diseases, University Hospital, Università della Campania "Luigi Vanvitelli,", Naples, Italy.
Michela PetrizzoDivision of Endocrinology and Metabolic Diseases, University Hospital, Università della Campania "Luigi Vanvitelli,", Naples, Italy.
Giuseppe BellastellaDepartment of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli,", Naples, Italy.ORCID 0000-0002-4748-321X
Maria Ida MaiorinoDepartment of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli,", Naples, Italy.ORCID 0000-0003-4659-7546
Katherine EspositoDepartment of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli,", Naples, Italy.ORCID 0000-0002-3652-5154
University of Campania "Luigi Vanvitelli" · IT

Funding

Associazione Salute con Stile (Naples, Italy) 1.2022
6 · The paper itself

Abstract

purposeTo assess the magnitude and durability of the metabolic benefits by simplification of complex insulin treatments in patients with type 2 diabetes inadequately controlled by a full basal-bolus insulin regimen. Herein we report the results of the scheduled 2-year extension of the BEYOND trial.

methodsOriginally, 305 participants with inadequate glycemic control (HbA1c > 7.5%) were randomly assigned to intensification of basal-bolus insulin regimen (n = 101), to a fixed-ratio combination (basal insulin + GLP-1RA, n = 102), or to an association of basal insulin plus an SGLT-2 inhibitor (gliflo-combo, n = 102). The primary efficacy outcome was change from baseline in HbA1c at 24 months assessed by an intention-to-treat analysis. A per-protocol analysis was also performed.

resultsFifty-five percent of patients completed the study in the two comparison arms. Compared with patients randomized to basal-bolus, patients of the other groups experienced non statistically different reductions in HbA1c level according to either an intention-to-treat analysis (-0.8 ± 1.1%, -0.7 ± 1.1%, and -1.3 ± 1.1%, mean ± SD, fixed-ratio, gliflo-combo and basal bolus, respectively) or per-protocol analysis (-1.2 ± 1.0%, -1.2 ± 1.1%, and -1.3 ± 1.0%, respectively). The final HbA1c level (per protocol) was 7.2 ± 0.8%, 7.3 ± 0.9%, and 7.5 ± 0.9%, respectively (P = NS). Treatment satisfaction (DTSQ) increased in both exchange groups, whereas the proportion of patients with hypoglycemia was lower.

conclusionSimplification of complex insulin regimen may be a durable option in at least one-half of patients with type 2 diabetes. CLINICAL

trial registrationClinical trial registration no. NCT04196231, clinicaltrials.gov.

Indexed as

Diabetes Mellitus, Type 2InsulinBlood GlucoseGlycated HemoglobinHumansHypoglycemic AgentsBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinBasal bolus insulin regimenBasal insulin plus gliflozinBEYOND trialFixed-ratio combinationHbA1cType 2 diabetes

Identifiers

PMID37787888
PMCPMC10850008
OpenAlexW4387296913

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.