Deintensification of basal-bolus insulin after initiation of GLP-1RA in patients with type 2 diabetes under routine care

Bonora, Benedetta Maria; Rigato, Mauro; Frison, Vera; Dambrosio, Michele; Tadiotto, Federica; Lapolla, Annunziata; Simioni, Natalino; Paccagnella, Agostino; Avogaro, Angelo; Fadini, Gian Paolo

doi:10.1016/j.diabres.2021.108686

Cited by 11 publications

(9 citation statements)

References 23 publications

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“…In parallel, we acknowledge that the GLP-1RA/BI association is a valuable option in the management of T2D, either as fixed-ratio or loose combination. It can be helpful in the subsequent steps of therapeutic intensification and to simplify regimens as an alternative to basal-bolus insulin [ 40 , 41 ]. The widespread use of weekly injectable GLP-1RA has improved acceptability of this therapy.…”

Section: Discussionmentioning

confidence: 99%

Cardiovascular outcomes after initiating GLP-1 receptor agonist or basal insulin for the routine treatment of type 2 diabetes: a region-wide retrospective study

Longato

Camillo

Sparacino

et al. 2021

Cardiovasc Diabetol

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Aim We aimed to compare cardiovascular outcomes of patients with type 2 diabetes (T2D) who initiated GLP-1 receptor agonists (GLP-1RA) or basal insulin (BI) under routine care. Methods We accessed the administrative claims database of the Veneto Region (Italy) to identify new users of GLP-1RA or BI in 2014–2018. Propensity score matching (PSM) was implemented to obtain two cohorts of patients with superimposable characteristics. The primary endpoint was the 3-point major adverse cardiovascular events (3P-MACE). Secondary endpoints included 3P-MACE components, hospitalization for heart failure, revascularizations, and adverse events. Results From a background population of 5,242,201 citizens, 330,193 were identified as having diabetes. PSM produced two very well matched cohorts of 4063 patients each, who initiated GLP-1RA or BI after an average of 2.5 other diabetes drug classes. Patients were 63-year-old and only 15% had a baseline history of cardiovascular disease. During a median follow-up of 24 months in the intention-to-treat analysis, 3P-MACE occurred less frequently in the GLP-1RA cohort (HR versus BI 0.59; 95% CI 0.50–0.71; p < 0.001). All secondary cardiovascular endpoints were also significantly in favor of GLP-1RA. Results were confirmed in the as-treated approach and in several stratified analyses. According to the E-value, confounding by unmeasured variables were unlikely to entirely explain between-group differences in cardiovascular outcomes. Conclusions Patients with T2D who initiated a GLP-1RA experienced far better cardiovascular outcomes than did matched patients who initiated a BI in the same healthcare system. These finding supports prioritization of GLP-1RA as the first injectable regimen for the management of T2D.

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Section: Discussionmentioning

confidence: 99%

Cardiovascular outcomes after initiating GLP-1 receptor agonist or basal insulin for the routine treatment of type 2 diabetes: a region-wide retrospective study

Longato

Camillo

Sparacino

et al. 2021

Cardiovasc Diabetol

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“…Italian observational retrospective studies involving patients with T2D treated with IDegLira coming from either BOT or BB regimens with unsatisfactory glycemic control showed significant reductions in HbA1c and fasting blood glucose (FBG) with no gain in body weight and a lower number of concomitant diabetes medications [ 18 – 21 ]. In general, on the basis of randomized clinical trials and observational studies, between 50% and 60% of patients with T2D on BB can successfully stop bolus insulin by switching to a GLP-1RA, including the fixed-dose combination IdegLira [ 22 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Fadini

Buzzetti

Fittipaldi³

et al. 2022

Diabetes Ther

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Introduction IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-022-01287-z.

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“…The routine care data captured by the REX study suggested that, among patients with T2D who are uncontrolled while on a BB insulin regimen, there is room for improving HbA1c and reducing body weight with less injection burden after switching to IDegLira. Previous observational studies and the BEYOND randomized trial have confirmed the feasibility of de‐intensifying a BB insulin regimen, particularly in patients with a short duration of T2D and relatively low insulin doses 27,32 . However, the long‐term persistence of such an effect should be carefully scrutinized.…”

Section: Discussionmentioning

confidence: 99%

IDegLira for the real‐world treatment of type 2 diabetes in Italy. Final results from the REX observational study

Fadini,

Buzzetti,

Pitocco

et al. 2024

Diabetes Obesity Metabolism

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AimThe study was designed to generate real‐world evidence on IDegLira in the Italian clinical practice in two groups of patients with type 2 diabetes (T2D), switching to IDegLira either from a basal only (basal group) or basal‐bolus insulin regimen (BB group).Materials and MethodsThis was a non‐interventional, multicentre, single‐cohort, prospective study assessing the long‐term glycaemic control in patients with T2D, who switched to IDegLira from a basal insulin ± glucose‐lowering medication regimen with or without a bolus insulin component for approximately 18 months, conducted in 28 Italian diabetes centres. The primary endpoint was the change in glycated haemoglobin (HbA1c) levels from baseline to 6 months after IDegLira initiation.ResultsThe study included 358 patients with a mean age 67.2 years and diabetes duration of 15.7 years. HbA1c significantly decreased from IDegLira start to all study time points in the overall population (basal group −1.19%; BB group −0.60% at the end of observation). Patients achieving HbA1c <7% levels increased from 12.9% (n = 43) to 40.3% (n = 110) at 18 months. Fasting blood glucose and body weight also significantly decreased in both groups, although more in the BB group. Overall, 14.3% of completed patients had an intensification of treatment (mainly in the basal group) and 48.6% had a simplification of treatment (mainly in the BB group).ConclusionsSwitching to IDegLira in a real‐world clinical setting is a valid therapeutic option for patients with T2D with inadequate glycaemic control on basal or BB insulin regimen and/or need to simplify their insulin therapy, with specific reasons and therapeutic goals according to different T2D management trajectories.

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Deintensification of basal-bolus insulin after initiation of GLP-1RA in patients with type 2 diabetes under routine care

Cited by 11 publications

References 23 publications

Cardiovascular outcomes after initiating GLP-1 receptor agonist or basal insulin for the routine treatment of type 2 diabetes: a region-wide retrospective study

Cardiovascular outcomes after initiating GLP-1 receptor agonist or basal insulin for the routine treatment of type 2 diabetes: a region-wide retrospective study

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

IDegLira for the real‐world treatment of type 2 diabetes in Italy. Final results from the REX observational study

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