Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog ® in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis
ConclusionsMealtime and postmeal URLi provide effective and comparable glycemic control in Japanese patients. Mealtime URLi demonstrated more effective PPG control compared to lispro.Trial RegistrationClinicalTrials.gov, NCT03214367. (Source: Diabetes Therapy)
Source: Diabetes Therapy - August 18, 2020 Category: Endocrinology Source Type: research
Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog ® in Japanese Patients With Type 2 Diabetes: PRONTO-T2D Subpopulation Analysis
ConclusionsURLi administered as prandial insulin in combination with basal insulin provides effective glycemic control when administered immediately before a meal in Japanese patients with T2DM. URLi was well tolerated in this population.Trial RegistrationClinicalTrials.gov, NCT03214380. (Source: Diabetes Therapy)
Source: Diabetes Therapy - August 18, 2020 Category: Endocrinology Source Type: research
Update on Biosimilar Insulins: A US Perspective
AbstractThe development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar® (insulin glargine) and Admelog® (insulin lispro) have undergone extensive testing, and have gained significant use by patients in the US. Despite the availability of these follow-on products, the price of insulin has remained stubbornly high. New regulatory guidance under the Biologics Price Competition and Innovations Act that came into effect in March 2020 introduced an abbreviated pathway for the approval of biosimilar insulins and introduced the option t...
Source: BioDrugs - July 16, 2020 Category: Drugs & Pharmacology Source Type: research
[Research Articles] An ultrafast insulin formulation enabled by high-throughput screening of engineered polymeric excipients
Insulin has been used to treat diabetes for almost 100 years; yet, current rapid-acting insulin formulations do not have sufficiently fast pharmacokinetics to maintain tight glycemic control at mealtimes. Dissociation of the insulin hexamer, the primary association state of insulin in rapid-acting formulations, is the rate-limiting step that leads to delayed onset and extended duration of action. A formulation of insulin monomers would more closely mimic endogenous postprandial insulin secretion, but monomeric insulin is unstable in solution using present formulation strategies and rapidly aggregates into amyloid fibrils. ...
Source: Science Translational Medicine - June 30, 2020 Category: Biomedical Science Authors: Mann, J. L., Maikawa, C. L., Smith, A. A. A., Grosskopf, A. K., Baker, S. W., Roth, G. A., Meis, C. M., Gale, E. C., Liong, C. S., Correa, S., Chan, D., Stapleton, L. M., Yu, A. C., Muir, B., Howard, S., Postma, A., Appel, E. A. Tags: Research Articles Source Type: research
Bioequivalence of Ultra Rapid Lispro (URLi) U100 and U200 Formulations in Healthy Subjects
ConclusionsThis study demonstrated that the U100 and U200 URLi formulations are bioequivalent. The accelerated insulin absorption observed for the U100 formulation was maintained with the U200 URLi formulation. Further, the GD were similar for both formulations, supporting the ability of individuals to transfer from U100 to U200 URLi in a 1:1 unit conversion.Trial RegistrationNCT03616977. (Source: Diabetes Therapy)
Source: Diabetes Therapy - June 12, 2020 Category: Endocrinology Source Type: research
Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog ® (Lispro) in Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus: A Randomised Controlled Trial
ConclusionIn patients with T1DM, URLi showed ultra-rapid pharmacokinetics and glucodynamics, with the differences between URLi and Humalog in elderly patients mirroring those in younger adults.ClinicalTrials.gov identifier: NCT03166124. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - May 28, 2020 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog ® (Lispro) in Patients with Type 2 Diabetes Mellitus: A Phase I Randomised, Crossover Study
ConclusionsThis is the first study to investigate URLi in patients with T2DM using a euglycaemic clamp procedure. URLi demonstrated ultra-rapid pharmacokinetics and glucodynamics in patients with T2DM.ClinicalTrials.gov identifier:NCT03305822. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - May 28, 2020 Category: Drugs & Pharmacology Source Type: research
Matrix-assisted laser desorption/ionization in-source decay mass spectrometry analysis of human insulin and insulin analogues for the identification of insulin from insulin preparations
ConclusionsThe MALDI-ISD method is a rapid and convenient approach to identify human insulin and six insulin analogues that are components of all insulin preparations sold in Japan. In particular, this method can discriminate human insulin from insulin lispro, both of which have identical molecular weights, and therefore identifying them is difficult using conventional methods. (Source: Forensic Toxicology)
Source: Forensic Toxicology - April 23, 2020 Category: Forensic Medicine Source Type: research
Insulin and heparin challenge tests are useful for choosing an optimal insulin regimen in a case of subcutaneous insulin resistance
AbstractA 38 ‐year‐old woman with type 1 diabetes, whose fasting plasma glucose levels were>500 mg/dL under 176 U/day of subcutaneous insulin injection, was admitted to our hospital. When insulin was administrated intravenously, she was able to maintain favorable glycemic control even under 24 U/day of regular insulin; indicating that subcutaneous insulin resistance (SIR) was accompanied. To choose an optimal insulin regimen, we performed subcutaneous insulin challenge tests without or with heparin mixture and found a cocktail of insulin lispro and heparin could reduce blood glucose levels markedly. In consequence, ...
Source: Journal of Diabetes Investigation - April 7, 2020 Category: Endocrinology Authors: Yuko Nakamura,
Mototsugu Nagao,
Shunsuke Kobayashi,
Takeshi Oba,
Yuki Shuto,
Izumi Fukuda,
Shinichi Oikawa,
Hitoshi Sugihara Tags: CASE REPORT Source Type: research
The Effect of LM25 and LM50 on Hypoglycemia in Chinese T2DM Patients: Post Hoc Analysis of a Randomized Crossover Trial
ConclusionsThe risk of nocturnal hypoglycemia in the LM50 regimen was lower than that in the LM25 regimen under the HCD pattern, and the safety range of bedtime glucose for the LM50 regimen was wider than that of the LM25 regimen in Chinese T2DM patients. Premixed insulin analogs combined with acarbose were more helpful to reduce the incidence of hypoglycemia.Trial Registrationhttp://www.chictr.org.cn #ChiCTR-TTRCC-12002516. (Source: Diabetes Therapy)
Source: Diabetes Therapy - January 23, 2020 Category: Endocrinology Source Type: research
Reassessment of an Innovative Insulin Analogue Excludes Protracted Action yet Highlights Distinction between External and Internal Diselenide Bridges.
Abstract
Long-acting insulin analogues represent the most prescribed class of therapeutic proteins. An innovative design strategy was recently proposed: diselenide substitution of an external disulfide bridge. This approach exploited the distinctive physicochemical properties of selenocysteine (U). Relative to wild type (WT), Se-insulin[C7UA , C7UB ] was reported to be protected from proteolysis by insulin-degrading enzyme (IDE), predicting prolonged activity. Because of this strategy's novelty and potential clinical importance, we sought to validate these findings and test their therapeutic utility in an ...
Source: Chemistry - January 19, 2020 Category: Chemistry Authors: Weiss M, Dhayalan B, Chen YS, Phillips N, Swain M, Rege N, Mirsalehi A, Jarosinski M, Ismail-Beigi F, Metanis N Tags: Chemistry Source Type: research
Biosimilars and Novel Insulins
Conclusions:
Biosimilar insulins have comparable PK-PD profiles and equivalent efficacy and safety to original insulins at a lower price, making them available for more people with diabetes. Faster aspart is the first ultrafast-acting insulin. New upcoming clinical trials and more clinical experience with faster aspart will show the real potential of this new insulin. (Source: American Journal of Therapeutics)
Source: American Journal of Therapeutics - December 27, 2019 Category: Drugs & Pharmacology Tags: Therapeutic Advances Source Type: research
Ultra ‐Rapid Lispro results in accelerated insulin lispro absorption and faster early insulin action in comparison to Humalog® in Japanese patients with type 1 diabetes
ConclusionsIn Japanese T1DM patients, URLi demonstrated accelerated insulin lispro absorption, reduced late exposure, overall shorter duration, and faster early insulin action compared to lispro. (Source: Journal of Diabetes Investigation)
Source: Journal of Diabetes Investigation - December 8, 2019 Category: Endocrinology Authors: Masanari Shiramoto,
Risa Nasu,
Tomonori Oura,
Makoto Imori,
Kenji Ohwaki Tags: ORIGINAL ARTICLE Source Type: research
Comparison of metabolic and mitogenic response in vitro of the rapid-acting insulin lispro product SAR342434, and US- and EU-approved Humalog®
Publication date: Available online 11 October 2019Source: Regulatory Toxicology and PharmacologyAuthor(s): Marcus Korn, Paulus Wohlfart, Thomas Gossas, Mari Kullman-Magnusson, Birgit Niederhaus, Juergen Dedio, Norbert TennagelsAbstractSAR342434 is a biosimilar of insulin lispro (Humalog® U-100). Batches of SAR342434 were compared with Humalog® batches of either EU or US origin in a panel of in vitro biological assays that included insulin binding to insulin receptor (IR) isoforms A (IR-A) and B (IR-B) and IR-A/IR-B autophosphorylation. A surface plasmon resonance biosensor-based assay was developed to characterize the ki...
Source: Regulatory Toxicology and Pharmacology - October 11, 2019 Category: Toxicology Source Type: research
Comparison of metabolic and mitogenic response in vitro of the rapid-acting insulin lispro product SAR342434, and US- and EU-approved Humalog ®.
Comparison of metabolic and mitogenic response in vitro of the rapid-acting insulin lispro product SAR342434, and US- and EU-approved Humalog®.
Regul Toxicol Pharmacol. 2019 Oct 11;:104497
Authors: Korn M, Wohlfart P, Gossas T, Kullman-Magnusson M, Niederhaus B, Dedio J, Tennagels N
Abstract
SAR342434 is a biosimilar of insulin lispro (Humalog® U-100). Batches of SAR342434 were compared with Humalog® batches of either EU or US origin in a panel of in vitro biological assays that included insulin binding to insulin receptor (IR) isoforms A (IR-A) and B (IR-B) and IR-A/IR-B autop...
Source: Regulatory Toxicology and Pharmacology : RTP - October 10, 2019 Category: Toxicology Authors: Korn M, Wohlfart P, Gossas T, Kullman-Magnusson M, Niederhaus B, Dedio J, Tennagels N Tags: Regul Toxicol Pharmacol Source Type: research
