Concentrated insulins: History and critical reappraisal

Heinemann, Lutz; Beals, John M.; Malone, James; Anderson, James H.; Jacobson, Jennie G.; Sinha, Vikram; Corrigan, Sheila M.

doi:10.1111/1753-0407.12861

Cited by 17 publications

(14 citation statements)

References 63 publications

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“…Endocrinologists, rheumatologists, gastroenterologists, and dermatologists have been prescribing biologics for at-home injection for many years. The best-known example, insulin, has been in use for nearly 100 years 24. At-home self-administration has the potential to reduce the burden on specialty clinics and allow physicians time to treat more patients with severe asthma.…”

Section: Discussionmentioning

confidence: 99%

<p>Single-Use Autoinjector Functionality And Reliability For At-Home Administration Of Benralizumab For Patients With Severe Asthma: GRECO Trial Results</p>

Ferguson¹,

Cole²,

Aurivillius³

et al. 2019

JAA

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PurposeAccessorized prefilled syringes (APFS) have demonstrated functionality and reliability for subcutaneous (SC) delivery, including self-administration, of benralizumab 30 mg in the clinic or at home. The multicenter, open-label GRECO study (NCT02918071) assessed functionality and reliability of a single-use autoinjector (AI) for at-home benralizumab administration by patients or their caregivers.Patients and methodsAdults with severe asthma received benralizumab SC injections at the study site at Weeks 0, 4, and 8. The first dose was administered by health care providers. Patients/caregivers had the option of administering the second dose and were required to administer the third dose under supervision. At Weeks 12 and 16, patients/caregivers administered benralizumab via AI at home. After each administration, patients/caregivers completed questionnaires concerning administration and device functioning. All AI devices used were returned for evaluation.ResultsA total of 595 AIs were used for 121 patients (mean age 48.5 years; 64% female) in the clinic and at home. Of 116 participants, 113 (97.4%; 95% confidence interval [CI]: 92.63–99.46) and 112 (96.6%; 95% CI: 91.41–99.05) successfully administered benralizumab at home at Weeks 12 and 16, respectively; 108 (93.1%; 95% CI: 86.86–96.98) were successful on both occasions. Throughout the study, 10 (1.7%) AI administrations were unsuccessful: 8 (1.3%) because of user error, 1 (0.2%) with undetermined cause, and 1 (0.2%) because of a manufacturing defect. Benralizumab efficacy (assessed by Asthma Control Questionnaire 6 score) and pharmacokinetics for patients using the AI were comparable to published results for patients receiving benralizumab via syringe in a clinical setting. No new or unexpected safety findings were observed.ConclusionAIs were functional, reliable, and performed well in the clinic and at home. Nearly all patients and caregivers successfully administered SC benralizumab via AI. Benralizumab availability in AI and APFS could provide patients with choices for self-administration.

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Section: Discussionmentioning

confidence: 99%

<p>Single-Use Autoinjector Functionality And Reliability For At-Home Administration Of Benralizumab For Patients With Severe Asthma: GRECO Trial Results</p>

Ferguson¹,

Cole²,

Aurivillius³

et al. 2019

JAA

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“…High concentration human insulin is available at 500 U/mL. These high concentration insulins may offer benefits to certain patients because of their diverse pharmacological profiles and clinical characteristics 8,9 .…”

Section: Introductionmentioning

confidence: 99%

Patient characteristics of insulin lispro 200 units/mL users in real world setting in Germany

Schloot

Pérez-Nieves

Sapin³

et al. 2020

Current Medical Research and Opinion

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Objective: Insulin lispro 200 U/mL (IL200) is a treatment choice for people with diabetes who have daily mealtime insulin (MTI) requirements of >20 U/day. We report clinical characteristics of real world IL200 users in Germany to understand clinical settings and the type of patients who would benefit from IL200 treatment. Methods: This retrospective database analysis used the patient-level data from "IMS Disease Analyzer" in Germany from February 2015 to June 2016. Clinical and demographic information were collected and analyzed for IL200 users alongside that of those who were using more than 20 U a day of 100 U/ mL analog MTI. Results: Of the 17,261 patients using insulin, 811 were identified in IL200 group. The IL200 group had 60% men, mean ± SD age of 63.6 ± 11.9 years, and BMI of 36.2 ± 6.7 kg/m 2. Of these, 63.5% (n ¼ 515) were seen by diabetologists, while 36.5% (n ¼ 296) were seen by general practitioners (GPs). In the IL200 group, 77.7% used basal insulin concomitantly, >90% had !1 comorbidity, and 52% had !4 comorbidities; the most common being hypertension (75.2%), neuropathy (66.0%), and nephropathy (59.6%). Diabetologist-treated IL200 users were more likely to have multiple comorbidities as compared with those treated by GPs (15.0% vs. 12.9% for >5 comorbidities). Conclusions: IL200 is prescribed to people with diabetes who need more than 20 U/day of mealtime insulin and tend to be more obese, older, and with multiple comorbidities. Future research should explore how concentrated MTI can impact adherence and long-term glycemia.

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“…They were confident that their patients would be adherent to MTI treatment regimen when on IL200. Consistent with an overall assessment with concentrated insulins, this survey showed that IL200 was prescribed to patients with a wide range of insulin requirements [21,22]. The majority of patients taking IL200 were obese or overweight with T2DM and were likely to be severely insulin resistant.…”

Section: Discussionmentioning

confidence: 56%

An assessment of physician reasons for prescribing Insulin Lispro 200 units/ml in Germany

Chen

Pérez-Nieves

Oliveira

et al. 2020

Postgraduate Medicine

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Objective: To understand physicians' reasons for prescribing Insulin Lispro 200 units/ml (IL200) and their experience with IL200 treatment in Germany. Methods: The survey consisted of 28 questions on physician's profile, average IL200 patients' characteristics and rationales for prescribing IL200. Questions were rated on a scale of 0 ('not at all important'/'strongly disagree') to 4 ('absolutely important'/'strongly agree'). Results: The surveyed physicians had a mean (SD) experience of 18.1 (7.0) years managing diabetes, consulted an average of 226.8 patients with diabetes/month and prescribed IL200 to 56.1% of their patients on mealtime insulin (MTI). About 80.0% of IL200 patients had type 2 diabetes mellitus, were overweight/ obese, and received >20 units/day of MTI. More than 70.0% of physicians rated patient's insulin dose, pattern of self-measured glucose levels, hemoglobin A1c (HbA1c) (clinical); adherence, hypoglycemia knowledge, motivation to improve lifestyle, desire to reduce injection volume and emotional struggle with controlling HbA1c (behavioral) as 'very important'/'absolutely important' factors when prescribing IL200. Conclusion: Physicians considered IL200 a promising treatment option that reduces the injection burden for patients on MTI. Physicians adopted a patient-centered perspective by aligning IL200 prescribing decisions with each patient's medical needs and non-clinical preferences, with an aim to encourage treatment adherence through resorting to IL200's advantageous attributes.

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Concentrated insulins: History and critical reappraisal

Cited by 17 publications

References 63 publications

<p>Single-Use Autoinjector Functionality And Reliability For At-Home Administration Of Benralizumab For Patients With Severe Asthma: GRECO Trial Results</p>

<p>Single-Use Autoinjector Functionality And Reliability For At-Home Administration Of Benralizumab For Patients With Severe Asthma: GRECO Trial Results</p>

Patient characteristics of insulin lispro 200 units/mL users in real world setting in Germany

An assessment of physician reasons for prescribing Insulin Lispro 200 units/ml in Germany

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