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

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

doi:10.2337/dc20-2623

Cited by 33 publications

(30 citation statements)

References 22 publications

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“…The three new drugs were also likely to have caused the decreased use of sulfonylureas, αGI and pioglitazone, in line with reports from other countries 8 25–27. These new drugs could offer much better glycemic control with decreasing postprandial hyperglycemia, less hypoglycemia, and less weight gain, and often provide benefits with a smaller dose of insulin in insulin-treated patients 34–36. Clinical advantages and adverse effects should be taken into consideration for individualization of glycemic control, cost-effectiveness, and health management to explore the positioning of these new drugs within older established therapies 37…”

Section: Discussionmentioning

confidence: 64%

Trends in glycemic control in patients with insulin therapy compared with non-insulin or no drugs in type 2 diabetes in Japan: a long-term view of real-world treatment between 2002 and 2018 (JDDM 66)

Yokoyama

Araki

Yamazaki

et al. 2022

BMJ Open Diab Res Care

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IntroductionWe investigated trends in the proportion of diabetes treatment and glycemic control, which may be altered by recent advances in insulin and non-insulin drugs, in Japanese patients with type 2 diabetes.Research design and methodsA serial cross-sectional study was performed using a multicenter large-population database from the Japan Diabetes Clinical Data Management study group. Patients with type 2 diabetes who attended clinics belonging to the study group between 2002 and 2018 were included to examine trends in glycated hemoglobin A1c (HbA1c) by treatment group using multivariable non-linear regression model.ResultsThe proportion of patients with insulin only decreased from 15.0% to 3.6%, patients with insulin+non-insulin drugs increased from 8.1% to 15.1%, patients with non-insulin drugs increased from 50.8% to 67.0%, and those with no drugs decreased from 26.1% to 14.4% from 2002 to 2018, respectively. The HbA1c levels of each group, except for no drugs, continued to decrease until 2014 (unadjusted mean HbA1c (%) from 2002 to 2014: from 7.89 to 7.45 for insulin only, from 8.09 to 7.63 for insulin+non-insulin, and from 7.51 to 6.98 for non-insulin) and remained unchanged thereafter. Among insulin-treated patients, use of human insulin decreased, use of long-acting analog insulin increased, and concomitant use of non-insulin drugs increased (from 35.1% in 2002 to 80.9% in 2018), which included increased use of dipeptidyl peptidase 4 inhibitors, sodium-glucose cotransporter 2 inhibitors, and glucagon-like peptide 1 receptor agonists, and the persistently high use of metformin.ConclusionsDuring the past two decades, combined use of insulin and non-insulin drugs increased and glycemic control improved and leveled off after 2014 in Japanese patients with type 2 diabetes. Further studies of the trend in association with age and factors related to metabolic syndrome are necessary to investigate strategies aiming at personalized medicine in diabetes care.

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Section: Discussionmentioning

confidence: 64%

Trends in glycemic control in patients with insulin therapy compared with non-insulin or no drugs in type 2 diabetes in Japan: a long-term view of real-world treatment between 2002 and 2018 (JDDM 66)

Yokoyama

Araki

Yamazaki

et al. 2022

BMJ Open Diab Res Care

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“…Finally, the randomized, pragmatic, pilot BEYOND study provided evidence that it is possible and safe to switch from a basal-bolus regimen to a FRC. In fact, after 6 months, a similar HbA1c reduction (-0.6%) was obtained in patients intensifying previous basal-bolus therapy versus those switching to FRC (iGlarLixi or iDegLira), with lower insulin doses (62 U versus 27 U), fewer daily injections, and less hypoglycemia (17.8% versus 7.8% of patients with at least one episode) in the FRC group than in the basal-bolus group [20].…”

Section: Comparisons With Existing Knowledgementioning

confidence: 68%

“…Existing literature also showed that iGlarLixi is effective irrespective of age, diabetes duration, and ethnicity [18][19][20], and that iGlarLixi has an enhanced gastrointestinal tolerability compared with the single-agent GLP1-RA [18,19,[21][22][23][24].…”

Section: Comparisons With Existing Knowledgementioning

confidence: 94%

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Effectiveness, Safety, and Appropriateness in the Use of the Fixed-Ratio Combination of Insulin Glargine and Lixisenatide in Type 2 Diabetes: The ENSURE Retrospective Real-World Study

Candido

Modugno²,

Larosa³

et al. 2022

Diabetes Ther

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Introduction: Pivotal trials documented glycemic benefits of fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi), with no weight gain and low hypoglycemia risk in type 2 diabetes (T2D). This study aimed at assessing effectiveness and patterns of use of iGlarLixi in a real-world setting. Methods: This was a retrospective, multicenter, study, based on electronic medical records. All patients initiating iGlarLixi from May 2018 to July 2020 were considered.Results: Overall, 25 centers provided data on 675 patients initiating iGlarLixi with the following characteristics: age 66.4 ± 10.1 years, 54.2% men, T2D duration 15.5 ± 11.5 years, HbA1c 8.6 ± 1.4%, body mass index (BMI) 30.8 ± 5.3 kg/m 2 , 45.1% already treated with basal insulin, and 21.9% with basal bolus (± oral hypoglycemic agents). Metformin and sodium-glucose cotransporter-2 inhibitors were used in 76.0% and 0.9% of patients, respectively. Combinations of iGlarLixi with other glucose-lowering drugs such as sulfonylureas or short-acting insulin were found in 32.4% of patients. Effectiveness of iGlarLixi (N = 184) showed that HbA1c declined by 0.77% [95% confidence interval (CI) -1.00, -0.54] after 6 months. In combination with metformin and/or SGLT-2i (N = 117), HbA1c declined by -0.92% (95% CI -1.22, -0.62) and weight significantly decreased by 1.21 kg. iGlarLixi dose was suboptimally titrated. Safety data (N = 171) showed incidence rates of blood glucose B 70 and \ 54 mg/mL of 0.26 and 0.05 events per person-month during 6 months, respectively, with a risk reduction of about 75% with respect the 6 months before iGlarLixi initiation. No severe hypoglycemia was reported. Conclusion: In adults with T2D, effectiveness and safety of iGlarLixi were documented in a real-world setting; appropriateness of use and adequate titration should be urgently improved so that clinical practice outcomes become more comparable to clinical trials results. Further real-

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“…Furthermore, data reported from US real-world practice showed that patients on more than one insulin injection daily were able to switch to IDegLira without compromising on glycemic control (HbA 1c change of − 0.16%) [ 16 ]. Accordingly, the randomized pragmatic BEYOND trial recently demonstrated that switching from MDI (basal-bolus) regimen to either a once-daily fixed-ratio BI plus GLP-1RA combination or once-daily gliflozin plus BI scheme is safe and non-inferior to basal-bolus titration in terms of HbA 1c reduction, at least during the first 6 months of follow-up [ 22 ]. Demonstrating improved HbA 1c level (− 0.8%) and decrease in body weight (− 1.4 kg) in the MDI subgroup, the present study also provides data supporting the relevance of such a therapeutic strategy.…”

Section: Discussionmentioning

confidence: 99%

Initiation of the Fixed Combination IDegLira in Patients with Type 2 Diabetes on Prior Injectable Therapy: Insights from the EASY French Real-World Study

et al. 2022

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Introduction Combining basal insulin (BI) with glucagon-like peptide-1 receptor agonist (GLP-1RA) is recognized as a relevant option to optimize glucose control in type 2 diabetes (T2D). The EASY real-world study aimed to evaluate the modalities of initiation and the effectiveness of the insulin Degludec plus Liraglutide (IDegLira) fixed-ratio combination in the French health care system. Methods A retrospective analysis included all patients with T2D and prior injectable therapy (GLP1-RA and/or insulin) who started treatment with IDegLira from September 2016 to December 2017 in 11 French diabetes centers. Baseline characteristics, reasons for IDegLira initiation, and modes of implementation were collected from the medical records. Changes in HbA 1c and body weight were determined in patients with available follow-up data (nearest 6-month visit). Results IDegLira was initiated in 629 patients previously treated with GLP-1RA alone (11.6%), insulin alone (31.5% including 16.5% with BI and 14.9% with multiple daily injections [MDI]) or a free combination of GLP-1RA and insulin (56.9% including 44.8% with BI and 12.1% with MDI), associated or not with oral agents. IDegLira starting dose (mean of 29 ± 11 dose steps) most often exceeded the recommended dose, and was significantly correlated with prior BI but not GLP-1RA dosage. At initiation, mean age, body mass index (BMI) and HbA 1c were 60.1 ± 10.2 years, 33.4 ± 6.2 kg/m 2 and 8.8 ± 1.7%, respectively. In 461 patients with available follow-up (median 178 days), HbA 1c decreased in all subgroups submitted to treatment intensification (− 1.7 ± 1.8% [ p < 0.0001], − 1.2 ± 1.8% [ p < 0.001] and − 0.8 ± 1.8% [ p = 0.0026] in patients with prior GLP-1RA, BI or MDI therapy, respectively) but also in those switching from BI and GLP-1RA free combination (− 0.2 ± 0.9%, p = 0.0419). Significant body weight gain occurred in patients previously treated with GLP-1RA alone (+ 1.5 ± 5.8 kg, p = 0.0572) or combined to BI (+ 1.0 ± 3.1 kg, p < 0.0001) while those on BI (− 1.4 ± 4.6 kg, p = 0.0139) or MDI (− 1.4 ± 5.0 kg, p = 0.0484) experienced weight loss. Conclusions While providing new information on the use of IDegLira in the French healthcare system, these data confirm the effectiveness of this fixed-ratio combination in the management of T2D. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-022-01327-8.

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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

Cited by 33 publications

References 22 publications

Trends in glycemic control in patients with insulin therapy compared with non-insulin or no drugs in type 2 diabetes in Japan: a long-term view of real-world treatment between 2002 and 2018 (JDDM 66)

Trends in glycemic control in patients with insulin therapy compared with non-insulin or no drugs in type 2 diabetes in Japan: a long-term view of real-world treatment between 2002 and 2018 (JDDM 66)

Effectiveness, Safety, and Appropriateness in the Use of the Fixed-Ratio Combination of Insulin Glargine and Lixisenatide in Type 2 Diabetes: The ENSURE Retrospective Real-World Study

Initiation of the Fixed Combination IDegLira in Patients with Type 2 Diabetes on Prior Injectable Therapy: Insights from the EASY French Real-World Study

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