Efficacy and safety of <scp>LY2963016</scp> insulin glargine compared with insulin glargine (<scp>L</scp>antus®) in patients with type 1 diabetes in a randomized controlled trial: the <scp>ELEMENT</scp> 1 study

Blevins, Thomas; Dahl, Dominik; Rosenstock, Julio; Ilag, Leodevico L.; Huster, William J.; Zielonka, J.; Pollom, Robyn K.; Prince, Melvin

doi:10.1111/dom.12496

Cited by 71 publications

(127 citation statements)

References 13 publications

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“…The remaining 11 studies, all RCTs, met eligibility criteria and were included in the data synthesis [28][29][30][31][32][33][34][35][36][37][38]. Two open-label trials that studied LY2963016 and SAR342434 included an extension study that followed patients for up to 52 weeks to assess for immunogenicity and additional adverse events [33,35].…”

Section: Screening and Article Selectionmentioning

confidence: 99%

“…Five of the 11 trials assessed clinical efficacy (Table 2), with 3 studies enrolling type 1 diabetics and 2 studies enrolling type 2 diabetics [32][33][34][35]38]. These studies compared Basalog and LY2963016 to Lantus and SAR342434 to Humalog.…”

Section: Clinical Efficacy Outcomesmentioning

confidence: 99%

“…All trials showed equivalence between biosimilars and reference products based on their pre-specified margins. Though not powered to test a treatment difference at 52 weeks, Blevins (2015) and Garg (2017) trials, which were extended for an additional 28 and 26 weeks, respectively, for safety assessment, also demonstrated clinical efficacy equivalence at that time point.…”

Section: Clinical Efficacy Outcomesmentioning

confidence: 99%

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Efficacy and Safety of Biosimilar Insulins Compared to Their Reference Products: A Systematic Review

et al. 2018

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Section: Screening and Article Selectionmentioning

confidence: 99%

Section: Clinical Efficacy Outcomesmentioning

confidence: 99%

Section: Clinical Efficacy Outcomesmentioning

confidence: 99%

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Efficacy and Safety of Biosimilar Insulins Compared to Their Reference Products: A Systematic Review

et al. 2018

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“…Relative magnitudes of clinical studies for generic medicines 64, biosimilar LY insulin glargine 32, 35, 37, 38, 41, 43 and new molecular entities 65. The sizes of the circles do not necessarily represent the relative sizes of the trials between categories.…”

Section: Differences Between Biosimilar and Generic Medicinesmentioning

confidence: 99%

Introduction of biosimilar insulins in Europe

et al. 2017

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Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar®), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize that insulin products are biologicals manufactured through complex biotechnology processes, and thus biosimilar insulins cannot be considered identical to their reference products. Strict regulatory guidelines adopted by authorities in Europe, the USA and some other countries help to ensure that efficacy and safety profiles of biosimilar insulins are not meaningfully different from those of the reference products, preventing entry of biological compounds not meeting quality standards and potentially affecting people's glycaemic outcomes. This review explains the concept of biosimilar medicines and outlines regulatory requirements for registration of biosimilar insulins in Europe, which is illustrated by the successful development of LY2963016 insulin glargine and MK‐1293 insulin glargine (Lusduna®). Preclinical and clinical comparative studies of the biosimilar insulin glargine programmes include in vitro bioassays for insulin and insulin‐like growth factor 1 receptor binding, assessment of in vitro biological activity, evaluation of pharmacokinetic/pharmacodynamic profiles in phase I studies and assessment of long‐term safety and efficacy in phase III studies. The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options and reduce costs of insulin therapy.

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“…The ELEMENT 1 trial was a 52-week, phase 3, open-label, parallel-group study in which patients received either LY2963016 or Gla-100 in combination with mealtime insulin lispro [66]. Insulin doses were titrated to achieve blood glucose ≥ or ~110 mg/dl (≤6.0 mmol/l).…”

Section: New Insulin Ly2963016mentioning

confidence: 99%

Hypoglycemia with New Generation Basal Analog Insulins: A Descriptive Critical Review

Thrasher¹

2015

J Diabetes Metab

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Optimizing the treatment of people with diabetes relies on balancing the benefits of glycemic control with the risk of hypoglycemia. Although insulin is essential for treating patients with type 1 diabetes mellitus, patient and physician concerns regarding an increased risk of hypoglycemia can lead to delays in initiating insulin treatment in patients with type 2 diabetes mellitus. This clinical inertia contributes to reduced glycemic control and poorer outcomes for patients. Advances in insulin agents have reduced the risk of hypoglycemia. In particular, the introduction of insulin glargine, the first basal analog insulin with a 24-hour glucose-lowering profile with no pronounced peak, represented a significant step towards achieving this goal.To further improve patient management, a number of insulin formulations and molecules are in development and are designed to have pharmacokinetic/pharmacodynamic (PK/PD) profiles allowing closer mimicking of normal physiologic insulin release. Here we review these new agents, and discuss their hypoglycemic risk as reported in clinical trials. In addition, the difficulties in making comparative evaluations from studies with different patient populations and definitions of hypoglycemia are discussed. Solutions to improve future clinical trials are suggested. In general, the improved PK/PD profiles of new-generation insulins appear to result in better clinical outcomes in terms of hypoglycemia. What is needed are head-to-head trials using standardized methods and criteria to allow clinicians to compare hypoglycemia rates between insulins, and help them to discuss appropriate choices of therapy with their patients.

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Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study

Abstract: Aims:To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus®) insulin glargine (IGlar) in patients with type 1 diabetes (T1D). Methods

Cited by 71 publications

References 13 publications

Efficacy and Safety of Biosimilar Insulins Compared to Their Reference Products: A Systematic Review

Efficacy and Safety of Biosimilar Insulins Compared to Their Reference Products: A Systematic Review

Introduction of biosimilar insulins in Europe

Hypoglycemia with New Generation Basal Analog Insulins: A Descriptive Critical Review

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