Ultra-long-acting insulins: A review of efficacy, safety, and implications for practice

Davis, Courtney; Fleming, Joshua W.; Malinowski, Scott S.; Brown, Meagan A.; Fleming, Laurie W.

doi:10.1097/jxx.0000000000000076

Cited by 11 publications

(6 citation statements)

References 46 publications

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“…These agents were not included within this analysis as the pharmacokinetic profiles differ significantly between these types of insulin and the selected insulins (NPH, detemir, and glargine) are more comparable in respect to durations of action. 29…”

Section: Methodsmentioning

confidence: 99%

The Comparative Dosing and Glycemic Control of Intermediate and Long-Acting Insulins in Adult Patients With Type 1 and 2 Diabetes Mellitus

Kabakov

Merker

2021

Journal of Pharmacy Technology

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Objective: The various basal insulin products possess differences in pharmacokinetics that can significantly impact glycemic control and total daily basal insulin dosing. In addition, there will be instances where transitions between the different long-acting insulins will need to be made. Because every basal insulin product is not interchangeable on a 1:1 unit-to-unit basis, it is important for health care providers to understand the expected dose adjustments necessary to maintain a similar level of glycemic control. Data Sources: A Medline and Web of Science search was conducted in September 2021 using the following keywords and medical subjecting headings: NPH, glargine, detemir, type 1 diabetes mellitus, and type 2 diabetes mellitus. Study Selection and Data Extraction: Included articles were those that followed adult patients with type 1 diabetes mellitus and/or type 2 diabetes mellitus and compared the following types of insulin: “NPH and glargine,” “NPH and detemir,” and “glargine and detemir” for at least 4 weeks, had documented basal insulin (BI) doses, and excluded pregnant patients. Data synthesis: Twenty-five articles were found that include adult type 1 and/or type 2 diabetes mellitus patients. Once daily NPH can be converted unit-to-unit to glargine or detemir. Twice daily NPH converted to glargine or detemir requires an initial 20% reduction in BI dose. An increase in dose of BI is recommended when transitioning from glargine to detemir. Glargine and detemir consistently resulted in improved glycemic control with lower incidence of hypoglycemic events compared with NPH. Conclusions: When transitioning between long-acting insulins, the doses are not always interchangeable on a 1:1 basis. Unit dose adjustments are likely if transitioning between BIs and can influence short-term parameters in the acute care setting and long-term parameters in the outpatient setting.

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Section: Methodsmentioning

confidence: 99%

The Comparative Dosing and Glycemic Control of Intermediate and Long-Acting Insulins in Adult Patients With Type 1 and 2 Diabetes Mellitus

Kabakov

Merker

2021

Journal of Pharmacy Technology

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“…47 The long-acting sustained-release agents are currently research hotspots due to the advantages, such as prolonging the activity of drugs, reducing the frequency of medication, and improving patient compliance. 48,49 Since most PBA nanoparticles are stable even after the release of the drug, if insulin is embedded or adsorbed on the surface of the polymer molecule of the long-acting sustained-release agent, the glucose sensitivity and the long-acting drug are combined, in order to slow the release of the drugs. Such materials include methacrylate (PMMA), polylactic acid (PLA), polylactic…”

Section: Pba Biomaterials Containing Long-acting Sustained-release Pomentioning

confidence: 99%

Bioresponsive Functional Phenylboronic Acid-Based Delivery System as an Emerging Platform for Diabetic Therapy

Ma¹,

Xiao-min²,

Shi³

et al. 2021

IJN

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The glucose-sensitive self-adjusting drug delivery system simulates the physiological model of the human pancreas-secreting insulin and then precisely regulates the release of hypoglycemic drugs and controls the blood sugar. Thus, it has good application prospects in the treatment of diabetes. Presently, there are three glucose-sensitive drug systems: phenylboronic acid (PBA) and its derivatives, concanavalin A (Con A), and glucose oxidase (GOD). Among these, the glucose-sensitive polymer carrier based on PBA has the advantages of better stability, long-term storage, and reversible glucose response, and the loading of insulin in it can achieve the controlled release of drugs in the human environment. Therefore, it has become a research hotspot in recent years and has been developed very rapidly. In order to further carry out a follow-up study, we focused on the development process, performance, and application of PBA and its derivatives-based glucose-sensitive polymer drug carriers, and the prospects for the development of this field.

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“…Recent developments include ultrarapid and ultra-long-acting insulin analogues. 3,4 Expiration of the patents for three widely used insulin analogues (insulins glargine, lispro, and aspart) allows other manufacturers to seek regulatory approval to market an insulin analogue that is highly similar in structure, safety, tolerability, and efficacy to the original biological product-known as a biosimilar. 5 Globally, one in two people needing insulin lack access.…”

Section: Introductionmentioning

confidence: 99%

Understanding Biosimilar Insulins - Development, Manufacturing, and Clinical Trials

Heinemann¹,

Davies

Home

et al. 2022

J Diabetes Sci Technol

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Background: A wave of expiring patents for first-generation insulin analogues has created opportunities in the global insulin market for highly similar versions of these products, biosimilar insulins. Biologics are generally large, complex molecules produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell. Since manufacturing processes of biologics vary, biosimilars cannot be exact copies of their reference product but must exhibit a high degree of functional and structural similarity. Biosimilarity is proven by analytical approaches in comparative assessments, preclinical cell-based and animal studies, as well as clinical studies in humans facilitating the accumulation of evidence across all assessments. The approval of biosimilars follows detailed regulatory pathways derived from those of their reference products and established by agencies such as the European Medicines Agency and the US Food and Drug Administration. Regulatory authorities impose requirements to ensure that biosimilars meet high standards of quality, safety, and efficacy and are highly similar to their reference product. Purpose: This review aims to aid clinical understanding of the high standards of development, manufacturing, and regulation of biosimilar insulins. Methods: Recent relevant studies indexed by PubMed and regulatory documents were included. Conclusions: Driven by price competition, the emergence of biosimilar insulins may help expand global access to current insulin analogues. To maximize the impact of the advantage for falling retail costs of biosimilar insulins compared with that of reference insulins, healthcare professionals and insulin users must gain further awareness and confidence.

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Ultra-long-acting insulins: A review of efficacy, safety, and implications for practice

Cited by 11 publications

References 46 publications

The Comparative Dosing and Glycemic Control of Intermediate and Long-Acting Insulins in Adult Patients With Type 1 and 2 Diabetes Mellitus

The Comparative Dosing and Glycemic Control of Intermediate and Long-Acting Insulins in Adult Patients With Type 1 and 2 Diabetes Mellitus

Bioresponsive Functional Phenylboronic Acid-Based Delivery System as an Emerging Platform for Diabetic Therapy

Understanding Biosimilar Insulins - Development, Manufacturing, and Clinical Trials

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