Healthcare Costs and Adherence Associated with Human Regular U-500 Versus High-Dose U-100 Insulin in Patients with Diabets

Eby, E.; Zagar, Anthony; Wang, Ping; Curtis, Bradley; Xie, Jianfei; Haldane, Diane; Idris, Iskandar; Hood, Robert C.; Jackson, Jeffrey A.

doi:10.4158/ep13407.or

Cited by 27 publications

(35 citation statements)

References 22 publications

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“…Therefore, frequency of injections was associated with adherence [48]. Significantly improved adherence was demonstrated in a retrospective analysis of a large US healthcare claims database in people with Type 1 diabetes mellitus or Type 2 diabetes mellitus receiving Reg-U500 insulin as compared to those receiving higher doses (!150 units/day) of Reg-U100 insulin [18,49]. Kabul et al [18] reported on an analysis of a prospective randomised clinical trial of severely insulinresistant people with Type 2 diabetes mellitus who switched from high-dose, high-volume U-100 insulin requiring multiple daily injections (median 5, range 2-10) to 2-or 3-times daily U-500.…”

Section: Improved Adherencementioning

confidence: 99%

Concentrated insulins in current clinical practice

Schloot

Hood

Corrigan

et al. 2019

Diabetes Research and Clinical Practice

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New concentrated insulins (exceeding 100 units/mL) and dedicated devices have recently become available, offering new treatment options for people with diabetes, for basal and prandial insulin supplementation. The concentrated insulin formulations range from 2-fold concentration (insulin lispro 200 units/mL) with rapid-acting prandial action to 5-fold concentration (human regular insulin, 500 units/mL) with basal and short-acting prandial actions. Long-acting basal insulins include degludec 200 units/mL and glargine 300 units/mL. Concentrated insulins have been developed with the goal of easing insulin therapy by reducing the volume and number of injections and in some cases making use of altered pharmacokinetic and pharmacodynamic properties. This review summarizes the unique characteristics of each concentrated insulin to help healthcare providers and people with diabetes understand how to best use them.

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Section: Improved Adherencementioning

confidence: 99%

Concentrated insulins in current clinical practice

Schloot

Hood

Corrigan

et al. 2019

Diabetes Research and Clinical Practice

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“…The extended application of U‐500R as insulin monotherapy via continuous subcutaneous insulin infusion (CSII) is driven by the need for novel alternative regimens for high insulin‐requiring people with type 2 diabetes . An estimated 25% of U‐500R insulin use is by CSII already, using pumps designed for U‐100 insulin . The safety and efficacy of U‐500R delivered by CSII has not been determined .…”

Section: Introductionmentioning

confidence: 99%

“…7 An estimated 25% of U-500R insulin use is by CSII already, using pumps designed for U-100 insulin. 8 The safety and efficacy of U-500R delivered by CSII has not been determined. 6 Use of U-500 insulin in a U-100 pump requires mathematical conversion and could be confusing; for example, 10 U of bolus insulin displayed on a U-100 pump would in fact deliver 50 U, or 5-fold more, if using U-500 insulin.…”

Section: Introductionmentioning

confidence: 99%

Human regular U‐500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study

Grunberger

Bhargava

et al. 2020

Diabetes Obesity Metabolism

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Aim To compare the safety and efficacy of U500‐R delivered by a novel, specifically designed U500‐R insulin pump with U‐500R delivered by multiple daily injections (MDI). Methods The phase 3 VIVID study randomized people with type 2 diabetes to U‐500R by continuous subcutaneous insulin infusion (CSII) or MDI. Participants (aged 18–85 years) had HbA1c ≥7.5% and ≤12.0% and a total daily dose of insulin >200 and ≤600 U/day. After a 2‐week transition to three times daily injections of U‐500R, participants were treated for 24 weeks with U‐500R by CSII or MDI. Treatment arms were compared using mixed model repeated measures analysis. Results The study randomized 420 participants (CSII: 209, MDI: 211) with 365 completers. Mean changes from baseline were: HbA1c, −1.27% (−13.9 mmol/mol) with CSII and −0.85% (−9.3 mmol/mol) with MDI (difference − 0.42% [−4.6 mmol/mol], P <0.001); fasting plasma glucose, −33.9 mg/dL (−1.9 mmol/L) with CSII and 1.7 mg/dL (0.09 mmol/L) with MDI (difference − 35.6 mg/dL [−2.0 mmol/L], P <0.001); total daily dose, 2.8 U with CSII and 51.3 U with MDI (P < 0.001). Weight changes and rates of documented symptomatic and severe hypoglycaemia were similar between groups; the CSII group had a higher rate of nocturnal hypoglycaemia. Conclusions In type 2 diabetes requiring high doses of insulin, both methods of U‐500R delivery lowered HbA1c. However, the CSII group attained greater HbA1c reduction with significantly less insulin. Individualized dose titration will be important to balance glycaemic control with hypoglycaemia risk.

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“…Prior to the U-500R titration-to-target trial, 1 clinicians had only their own clinical experience and largely retrospective, nonrandomized case reports/series, 25-29 real-world evidence studies, 30-32 and clinical reviews 3-5,33-37 to inform U-500R use. Treatment approaches varied among clinicians and experts, with some initiating U-500R with 1-to-1 total daily dose (TDD) transition (U-100 insulins to U-500R) evenly split over multiple daily doses (BID, TID, or 4-times-daily [QID]).…”

Section: Prior U-500r Dosing Recommendationsmentioning

confidence: 99%

“…Complex insulin regimens (up to 10 injections per day) 1 can increase patient burden and decrease adherence of all prescribed daily doses. 2,3,30,31 When switching to U-500R, if the prescriber neglects to determine the true home doses being administered and a much higher initial U-500R dose is prescribed, the patient is at an increased risk for hypoglycemia in the early transition period.…”

Section: Learnings From the U-500r Titration-to-target Rct Applied Tomentioning

confidence: 99%

Translating U-500R Randomized Clinical Trial Evidence to the Practice Setting: A Diabetes Educator/Expert Prescriber Team Approach

et al. 2017

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PurposeThe purpose of this article is to provide recommendations to the diabetes educator/expert prescriber team for the use of human regular U-500 insulin (U-500R) in patients with severely insulin-resistant type 2 diabetes, including its initiation and titration, by utilizing dosing charts and teaching materials translated from a recent U-500R clinical trial.ConclusionsClinically relevant recommendations and teaching materials for the optimal use and management of U-500R in clinical practice are provided based on the efficacy and safety results of and lessons learned from the U-500R clinical trial by Hood et al, current standards of practice, and the authors’ clinical expertise. This trial was the first robustly powered, randomized, titration-to-target trial to compare twice-daily and three-times-daily U-500R dosing regimens. Modifications were made to the initiation and titration dosing algorithms used in this trial to simplify dosing strategies for the clinical setting and align with current glycemic targets recommended by the American Diabetes Association. Leveraging the expertise, resources, and patient interactions of the diabetes educator who can provide diabetes self-management education and support in collaboration with the multidisciplinary diabetes team is strongly recommended to ensure patients treated with U-500R receive the timely and comprehensive care required to safely and effectively use this highly concentrated insulin.

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Healthcare Costs and Adherence Associated with Human Regular U-500 Versus High-Dose U-100 Insulin in Patients with Diabets

Cited by 27 publications

References 22 publications

Concentrated insulins in current clinical practice

Concentrated insulins in current clinical practice

Human regular U‐500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study

Translating U-500R Randomized Clinical Trial Evidence to the Practice Setting: A Diabetes Educator/Expert Prescriber Team Approach

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