Comparative effectiveness of Glargine 300 U/mL vs. Degludec 100 U/mL in patients with type 2 diabetes switching from 1° generation basal insulins

Buzzetti, Raffaella; Fadini, Gian Paolo; Larosa, Monica; Cucinotta, Domenico; Enrico, Gabellieri; Mauro, Alpestre; Alberto, Marangoni; Grappa, Bassano del; Pagotto, Uberto; Claudio, Bongiorno; Concetta, Gatta; Andrea, Del Buono; Olga, Lamacchia; Pasquale, Maiellaro; Daniela, Antenucci; Gabriele, Brandoni; Francesca, Borroni; Giovanna, Gregori; Antonino, Di Benedetto; Giuseppe, Placentino; Franco, Cavalot; Cristina, Barale; Paolo, Fadini Gian; Paola, Del Sindaco; Chiara, Di Loreto; Anichini, Roberto; Giuseppe, Citro; Paola, D'Angelo; Carletti, Silvia; Raffaella, Buzzetti; Sara, Sterpetti; Mignogna, Carmen; Paolo, Elli; Prosperini, Giuseppe; Sacco, Michele; Lucisano, Giuseppe; Rossi, Maria Chiara; Nicolucci, Antonio

doi:10.1016/j.numecd.2022.06.003

Cited by 4 publications

(7 citation statements)

References 13 publications

(15 reference statements)

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“…Similar to the real-world RESTORE program on basal insulin [14][15][16], a message that can be drawn from the results of this study is that the achievement of metabolic targets does not depend only on the initiation of a new drug, but also on its appropriate use and titration. In fact, there is an urgent need to limit association of inadequate OHAs such as sulfonylureas or short-acting insulin and reduce clinical inertia by optimizing iGlarLixi dosing.…”

Section: Implications For Research and Clinical Practicementioning

confidence: 74%

“…ENSURE was a multicenter, retrospective, cohort study based on electronic medical records (EMRs) (Smart Digital Clinic, software property of METEDA s.r.l., San Benedetto del Tronto, Italy). Methods were similar to those applied to previous multicenter, retrospective, cohort study based on EMRs [14][15][16].…”

Section: Methodsmentioning

confidence: 99%

“…Statistical methods were similar to those applied to previous multicenter, retrospective, cohort studies based on EMRs [14][15][16]. Descriptive data were summarized as mean and standard deviation (continuous, normally distributed variables), median and interquartile range (continuous, not normally distributed variables), or frequency and proportion (categorical variables).…”

Section: Statistical Analysesmentioning

confidence: 99%

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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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Section: Implications For Research and Clinical Practicementioning

confidence: 74%

Section: Methodsmentioning

confidence: 99%

Section: Statistical Analysesmentioning

confidence: 99%

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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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“…If Gla-300 and IDeg seem to have similar glycemic control improvements with relatively low hypoglycemia risk [ 4 , 5 ], further trials of direct comparisons of 2BI with first-generation basal insulins (1BI) [ 6 ] are probably needed. The use of real-life databases may answer some of the questions that arise in this field concerning, for example, the maintenance over time of treatment, or the comparative frequency of the main acute events linked to diabetes treatment (i.e.…”

Section: Introductionmentioning

confidence: 99%

Basal Insulinotherapy in Patients Living with Diabetes in France: The EF-BI Study

Gourdy,

Darmon,

Borget

et al. 2024

Diabetes Ther

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Introduction Second-generation basal insulins like glargine 300 U/mL (Gla-300) have a longer duration of action and less daily fluctuation and interday variability than first-generation ones, such as glargine 100 U/mL (Gla-100). The EF-BI study, a nationwide observational, retrospective study, was designed to compare persistence, acute care complications, and healthcare costs associated with the initiation of such basal insulins (BI) in a real-life setting in France. Methods This study was conducted using the French healthcare claims database (SNDS). Adult patients living with type 1 or type 2 diabetes mellitus (T1DM or T2DM) initiating Gla-300 or Gla-100 ± other hypoglycemic medications between January 1, 2016 and December 31, 2020, and without any insulin therapy over the previous 6 months were included. Persistence was defined as remaining on the same insulin therapy until discontinuation defined by a 6 month period without insulin reimbursement. Hospitalized acute complications were identified using ICD-10 codes. Total collective costs were established for patients treated continuously with each basal insulin over 1–3 years. All comparisons were adjusted using a propensity score based on initial patient/treatment characteristics. Results A total of 235,894 patients with T2DM and 6672 patients with T1DM were included. Patients treated with Gla-300 were 83% (T1DM) and 44% (T2DM) less likely to discontinue their treatment than those treated with Gla-100 after 24 months ( p < 0.0001). The annual incidence of acute hospitalized events in patients with T2DM treated with Gla-300 was 12% lower than with Gla-100 ( p < 0.0001) but similar in patients with T1DM. Comparison of overall costs showed moderate but statistically significant differences in favor of Gla-300 versus Gla-100 for all patients over the first year, and in T2DM only over a 3-year follow-up. Conclusion Use of Gla-300 resulted in a better persistence, less acute hospitalized events at least in T2DM, and reduced healthcare expenditure. These real-life results confirmed the potential interest of using Gla-300 rather than Gla-100.

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“…Second generation basal insulins, such as degludec and glargine 300, which are characterized by an extended duration of action and by a low pronounced pharmacokinetic peak, have shown a reduced risk of hypoglycemia while maintaining a good glycemic control, compared to other basal insulins [8][9][10]. Indeed, their use is recommended by the Italian SID-AMD and by international ADA guidelines [4,11].…”

Section: Of 17mentioning

confidence: 99%

Pharmacological and Benefit-Risk Profile of Once-Weekly Basal Insulin Administration (Icodec): Addressing Patients’ Unmet Needs and Exploring Future Applications

Ingrasciotta,

Vitturi,

Trifirò

2024

JCM

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Diabetes mellitus (DM) is a chronic metabolic disease affecting over 500 million people worldwide, which leads to severe complications and to millions of deaths yearly. When therapeutic goals are not reached with diet, physical activity, or non-insulin drugs, starting/adding insulin treatment is recommended by international guidelines. A novel recombinant insulin is icodec, a once-weekly insulin that successfully completed phase III trials and that has recently obtained the marketing authorization approval from the European Medicines Agency. This narrative review aims to assess icodec pharmacological and clinical features concerning evidence on benefit–risk profile, as compared to other basal insulins, addressing the potential impact on patients’ unmet needs. Icodec is a full agonist, recombinant human insulin analogue characterized by an ultra-long half-life (196h), enabling its use in once-weekly administration. Phase III randomized clinical trials involving more than 4,000 diabetic patients, mostly type 2 DM, documented non-inferiority of icodec, as compared to currently available basal insulins, in terms of estimated mean reduction of glycated hemoglobin levels; a superiority of icodec, compared to control, was confirmed in insulin-naïve patients (ONWARDS 1, 3, and 5), and in patients previously treated with basal insulin (ONWARDS 2). Icodec safety profile was comparable to the currently available basal insulins. Once-weekly icodec has the potential to improve patients’ adherence, thus positively influencing patients’ treatment satisfaction as well as quality of life, especially in type 2 DM insulin-naïve patients. An improved adherence might positively influence glycemic target achievement, reduce overall healthcare costs and overcome some of the unmet patients’ needs. Icodec has the potential to emerge as a landmark achievement in the evolution of insulin therapy, with a positive impact also for the National Health Services and the whole society.

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Comparative effectiveness of Glargine 300 U/mL vs. Degludec 100 U/mL in patients with type 2 diabetes switching from 1° generation basal insulins

Cited by 4 publications

References 13 publications

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

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

Basal Insulinotherapy in Patients Living with Diabetes in France: The EF-BI Study

Pharmacological and Benefit-Risk Profile of Once-Weekly Basal Insulin Administration (Icodec): Addressing Patients’ Unmet Needs and Exploring Future Applications

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