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https://www.readbyqxmd.com/read/29232162/efficacy-and-safety-of-biosimilar-sar342434-insulin-lispro-in-adults-with-type-2-diabetes-also-using-insulin-glargine-sorella-2-study
#1
Karl-Michael Derwahl, Timothy S Bailey, Karin Wernicke-Panten, Lin Ping, Suzanne Pierre
BACKGROUND: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (U100; Humalog®; Ly-Lis). This study aimed to show similar efficacy, safety, and immunogenicity of SAR-Lis versus Ly-Lis in adult patients with type 2 diabetes mellitus (T2DM) treated with multiple daily injections, while using insulin glargine (GLA-100; Lantus®) as basal insulin. METHODS: SORELLA 2 was a 6-month, randomized, open-label, Phase 3 study (NCT02294474). Insulin doses were adjusted to achieve fasting and 2-h postprandial glucose targets according to American Diabetes Association guidelines...
December 12, 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/29179857/transition-from-intravenous-insulin-to-subcutaneous-long-acting-insulin-in-critical-care-patients-on-enteral-or-parenteral-nutrition
#2
Analía Ramos, Lluis Zapata, Paula Vera, Antoni J Betbese, Antonio Pérez
BACKGROUND AND AIMS: The optimal initial dose of subcutaneous (SC) insulin after intravenous (IV) infusion is controversial, especially in patients receiving continuous enteral nutrition (EN) or total parenteral nutrition (TPN). The aim of this study was to evaluate the strategy used at our hospital intensive care unit (ICU) in patients switched from IV insulin to SC insulin glargine while receiving EN or TPN. DESIGN AND METHODS: A retrospective analysis was made of 27 patients on EN and 14 on TPN switched from IV infusion insulin to SC insulin...
December 2017: Endocrinología, Diabetes y Nutrición
https://www.readbyqxmd.com/read/29166786/understanding-concentrated-insulins-a-systematic-review-of-randomized-controlled-trials
#3
Fernando Ovalle, Alissa R Segal, John E Anderson, Michael R Cohen, Tina M Morwick, Jeffrey A Jackson
OBJECTIVE: To compile, analyze, and summarize the literature on concentrated insulins (i.e., concentrations >100 units/mL) from randomized controlled trials and derive guidance on appropriate use of these agents. METHODS: Searches were conducted in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and Trialtrove® (through April 2016) and ClinicalTrials.gov (through April 2017) for Phase 1-4 clinical studies using concentrated insulins. Selected studies included multiple-arm, randomized controlled trials evaluating subcutaneously administered concentrated insulins...
November 22, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29155123/baseline-factors-associated-with-better-response-to-insulin-lispro-low-mixture-or-insulin-glargine-a-post-hoc-analysis-of-the-durable-study
#4
Nan Jia, Zbigniew Kindracki, Angel Rodriguez
AIMS: To identify baseline characteristics associated with better efficacy and safety responses to twice-daily insulin lispro low mixture (LM) or once-daily insulin glargine (IG) in insulin-naïve patients with type 2 diabetes (T2D). METHODS: This post hoc analysis of the DURABLE study used the gradient-boosting method to generate hypothetical outcomes with the alternative treatment to assigned study drug to evaluate the potential additional benefit of one insulin over the other in association with influential baseline covariates in the same patient...
November 16, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/29114384/treatment-with-insulin-analogs-and-prevalence-of-cardiovascular-complications-in-patients-with-type-1-diabetes
#5
Christoph Hasslacher, Justo Lorenzo Bermejo
Background: A lower incidence of cardiovascular events has been reported in type 2 diabetes patients treated with insulin analogs (IAs). Corresponding data on people affected by type 1 diabetes are not available yet. Methodology: We investigated demographic and clinical data from 509 type 1 diabetics, who were treated in an outpatient clinic from 2006 to 2012. Multiple logistic regression was used to investigate the relationship between the type of insulin treatment and the prevalence of cardiovascular (CV) complications, that is, presence of coronary heart, cerebrovascular and peripheral arterial diseases, adjusting for potential confounders...
November 2017: Therapeutic Advances in Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29065720/identifying-insulin-treatment-responders-with-a-composite-measure-beyond-hba1c-7-in-patients-with-type-2-diabetes
#6
Ignacio Conget, M Sue Kirkman, Dachuang Cao, Mayme Wong, Jesus Reviriego, David M Kendall
OBJECTIVES: Many insulin-treated patients with type 2 diabetes (T2D) do not reach hemoglobin A1c (HbA1c) <7% but have clinically relevant HbA1c reductions. Using an integrated database (IDB) of 53 insulin lispro clinical trials and a real-world evidence (RWE) database of T2D patients initiating insulin therapy, an expanded HbA1c measure was used to identify responders to insulin therapy. METHODS: Analysis included 4908 patients (IDB) and 1134 patients (RWE) with T2D treated with any insulin regimen with a baseline and ≥1 postbaseline HbA1c...
October 24, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28887173/adsorption-effects-of-the-doping-relevant-peptides-insulin-lispro-synachten-tb-500-and-ghrp-5
#7
Péter Judák, Peter Van Eenoo, Koen Deventer
The tendency of peptides to adsorb to surfaces can raise a concern in variety of analytical fields where the qualitative/quantitative measurement of low concentration analytes (ng/mL-pg/mL) is required. To demonstrate the importance of using the optimal glassware/plasticware, four doping relevant model peptides (GHRP 5, TB-500, Insulin Lispro, Synachten) were chosen and their recovery from various surfaces were evaluated. Our experiments showed that choosing expensive consumables with low-bind characteristics is not beneficial in all cases...
November 15, 2017: Analytical Biochemistry
https://www.readbyqxmd.com/read/28864965/pharmacological-management-of-gestational-diabetes-mellitus
#8
Geetha Mukerji, Denice S Feig
Gestational diabetes mellitus (GDM) is associated with an increased risk of adverse pregnancy outcomes in the setting of poor glycemic control. The initial management for GDM includes intensive lifestyle modification, which often requires behavioral and nutritional changes to optimize glycemic control. Pharmacotherapy for GDM is initiated when glycemic targets are not met. The rapid-acting bolus analogues aspart and lispro achieve postprandial targets with less hypoglycemia compared to regular insulin, with similar fetal outcomes...
October 2017: Drugs
https://www.readbyqxmd.com/read/28832100/consensus-on-use-of-insulins-in-gestational-diabetes
#9
Kalyan Kumar Gangopadhyay, J J Mukherjee, R K Sahay
INTRODUCTION: Gestational Diabetes Mellitus (GDM), diabetes diagnosed during pregnancy is associated with maternal (caesarean delivery, hypoglycaemia, hyperbilirubinaemia, shoulder dystocia, pre-term delivery and birth trauma) and fetal (Hyperbilirubinaemia in offspring, Neonatal hypoglycaemia, Macrosomia) complications. Despite, insulin being the standard treatment for GDM cases, there is no existing comprehensive consensus update on use of insulin in Indian patients with GDM. OBJECTIVE: To provide simple and easily implementable guidelines to healthcare physicians on use of insulin in GDM...
March 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/28762200/rapid-acting-and-human-insulins-hexamer-dissociation-kinetics-upon-dilution-of-the-pharmaceutical-formulation
#10
Klaus Gast, Anja Schüler, Martin Wolff, Anja Thalhammer, Harald Berchtold, Norbert Nagel, Gudrun Lenherr, Gerrit Hauck, Robert Seckler
PURPOSE: Comparison of the dissociation kinetics of rapid-acting insulins lispro, aspart, glulisine and human insulin under physiologically relevant conditions. METHODS: Dissociation kinetics after dilution were monitored directly in terms of the average molecular mass using combined static and dynamic light scattering. Changes in tertiary structure were detected by near-UV circular dichroism. RESULTS: Glulisine forms compact hexamers in formulation even in the absence of Zn(2+)...
November 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28751575/effects-of-intranasal-insulin-on-triglyceride-rich-lipoprotein-particle-production-in-healthy-men
#11
RANDOMIZED CONTROLLED TRIAL
Changting Xiao, Satya Dash, Priska Stahel, Gary F Lewis
OBJECTIVE: Insulin administered directly into the brain acutely suppresses hepatic glucose production and triglyceride-rich lipoprotein (TRL) secretion in rodents. In addition, intranasally administered insulin, which selectively raises cerebrospinal fluid insulin concentration, suppresses hepatic glucose production in humans; however, its effect on TRL secretion in humans has not previously been examined. In this study, we examined whether intranasal insulin, administered at a dose that has previously been shown to suppress hepatic glucose production, modulates TRL particle secretion by the liver and intestine in humans...
September 2017: Arteriosclerosis, Thrombosis, and Vascular Biology
https://www.readbyqxmd.com/read/28722480/efficacy-and-safety-of-biosimilar-sar342434-insulin-lispro-in-adults-with-type-1-diabetes-also-using-insulin-glargine-sorella-1-study
#12
Satish K Garg, Karin Wernicke-Panten, Maria Rojeski, Suzanne Pierre, Yvonne Kirchhein, Krystyna Jedynasty
BACKGROUND: SAR342434 is a biosimilar follow-on of insulin lispro-Humalog(®). This study aimed to show similar efficacy, safety, and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin glargine (Lantus(®); GLA-100). MATERIALS AND METHODS: SORELLA-1 was a randomized, open-label phase 3 study (NCT02273180). Patients completing the 6-month main study continued on SAR-Lis or Ly-Lis, as randomized, for a 6-month safety extension...
September 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28702259/clinical-effects-cardiovascular-and-renal-outcomes-associated-with-rapid-acting-insulin-analogs-among-individuals-with-type-2-diabetes-a-nation-wide-observational-cohort-study
#13
Ann-Marie Svensson, Mervete Miftaraj, Stefan Franzén, Björn Eliasson
BACKGROUND: Rapid-acting insulin analogs (RAIs) have not been examined for long-term safety in randomized clinical trials. We performed a nationwide longitudinal cohort study among individuals with type 2 diabetes (T2DM) to address cardiovascular safety and mortality among users of lispro, aspart and glulisine insulins. METHODS: We used four national registers, following patients previously not treated with RAI but with continuous use of RAIs in 2005-2014 up to 6...
2017: Clinical Diabetes and Endocrinology
https://www.readbyqxmd.com/read/28700249/simulation-based-evaluation-of-dose-titration-algorithms-for-rapid-acting-insulin-in-subjects-with-type-2-diabetes-mellitus-inadequately-controlled-on-basal-insulin-and-oral-antihyperglycemic-medications
#14
Xiaosu Ma, Jenny Y Chien, Jennal Johnson, James Malone, Vikram Sinha
BACKGROUND: The purpose of this prospective, model-based simulation approach was to evaluate the impact of various rapid-acting mealtime insulin dose-titration algorithms on glycemic control (hemoglobin A1c [HbA1c]). METHODS: Seven stepwise, glucose-driven insulin dose-titration algorithms were evaluated with a model-based simulation approach by using insulin lispro. Pre-meal blood glucose readings were used to adjust insulin lispro doses. Two control dosing algorithms were included for comparison: no insulin lispro (basal insulin+metformin only) or insulin lispro with fixed doses without titration...
August 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28667381/differential-treatment-response-to-insulin-intensification-therapy-a-post-hoc-analysis-of-a-randomized-trial-comparing-premixed-and-basal-bolus-insulin-regimens
#15
Li Xin Shi, Peng Fei Li, Jia Ning Hou
INTRODUCTION: Identification of subgroups of patients that may benefit most from certain treatment is important because individual treatment response varies due to multiple contributing factors. The present study used the subgroup identification based on the differential effect search (SIDES) algorithm to identify subgroups with different treatment responses to insulin intensification therapies. METHODS: This was a post hoc analysis of a 24-week, multicenter, open-label, randomized, parallel study comparing prandial premixed therapy (PPT) to basal-bolus therapy (BBT)...
August 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28617434/lispro-mitigates-%C3%AE-amyloid-and-associated-pathologies-in-alzheimer-s-mice
#16
Ahsan Habib, Darrell Sawmiller, Song Li, Yang Xiang, David Rongo, Jun Tian, Huayan Hou, Jin Zeng, Adam Smith, Shengnuo Fan, Brian Giunta, Takashi Mori, Glenn Currier, Douglas Ronald Shytle, Jun Tan
Lithium has been marketed in the United States of America since the 1970s as a treatment for bipolar disorder. More recently, studies have shown that lithium can improve cognitive decline associated with Alzheimer's disease (AD). However, the current United States Food and Drug Administration-approved lithium pharmaceutics (carbonate and citrate chemical forms) have a narrow therapeutic window and unstable pharmacokinetics that, without careful monitoring, can cause serious adverse effects. Here, we investigated the safety profile, pharmacokinetics, and therapeutic efficacy of LISPRO (ionic co-crystal of lithium salicylate and l-proline), lithium salicylate, and lithium carbonate (Li2CO3)...
June 15, 2017: Cell Death & Disease
https://www.readbyqxmd.com/read/28587789/once-weekly-glucagon-like-peptide-1-receptor-agonist-albiglutide-vs-prandial-insulin-added-to-basal-insulin-in-patients-with-type-2-diabetes-mellitus-results-over-52-weeks
#17
Lawrence A Leiter, Jorge Luiz Gross, Francis Chow, Diane Miller, Susan Johnson, Bo Ahrén
We have previously reported that once-weekly albiglutide was noninferior to thrice-daily lispro for glycemic lowering, with decreased weight and risk of hypoglycemia, in patients inadequately controlled on basal insulin over 26 weeks. Findings after 52 weeks reveal similar responses to albiglutide as an add-on to insulin glargine.
May 25, 2017: Journal of Diabetes and its Complications
https://www.readbyqxmd.com/read/28576743/internalization-and-localization-of-basal-insulin-peglispro-in-cells
#18
Julie S Moyers, Catherine B Volk, Julia X C Cao, Chen Zhang, Liyun Ding, Vladislav V Kiselyov, M Dodson Michael
BACKGROUND: Basal insulin peglispro (BIL) is a novel, PEGylated insulin lispro that has a large hydrodynamic size compared with insulin lispro. It has a prolonged duration of action, which is related to a delay in insulin absorption and a reduction in clearance. Given the different physical properties of BIL compared with native insulin and insulin lispro, it is important to assess the cellular internalization characteristics of the molecule. METHODS AND MATERIALS: Using immunofluorescent confocal imaging, we compared the cellular internalization and localization patterns of BIL, biosynthetic human insulin, and insulin lispro...
October 15, 2017: Molecular and Cellular Endocrinology
https://www.readbyqxmd.com/read/28539526/insulin-lispro-25-75-and-insulin-lispro-50-50-as-starter-insulin-in-japanese-patients-with-type-2-diabetes-subanalysis-of-the-classify-randomized-trial
#19
Hirotaka Watada, Makoto Imori, Pengfei Li, Noriyuki Iwamoto
In Japan, premixed insulins are commonly used as starter insulin for type 2 diabetes. This subpopulation analysis assessed the efficacy and safety of twice-daily LM25 (25% insulin lispro/75% insulin lispro protamine) and LM50 (50% insulin lispro/50% insulin lispro protamine) as starter insulin in Japanese subjects, and compared these results with the whole-trial populations of East Asian subjects. In this subpopulation analysis of an open-label, phase 4, randomized trial (CLASSIFY), Japanese subjects received LM25 (n = 88) or LM50 (n = 84) twice-daily for 26 weeks...
May 24, 2017: Endocrine Journal
https://www.readbyqxmd.com/read/28475455/higher-concentration-insulins-an-overview-of-clinical-considerations
#20
REVIEW
Timothy S Reid, Fryn Schafer, Cynthia Brusko
Three higher concentration insulin products (insulin lispro 200 units/mL, insulin degludec 200 units/mL, and insulin glargine 300 units/mL) received US Food and Drug Administration (FDA) approval in 2015. Although human regular insulin 500 units/mL (U-500) was approved in 1997, a pen and dedicated U-500 syringe became available in 2016. These products offer more treatment options for the increasing numbers of patients requiring insulin to achieve and maintain glycemic targets. Higher concentration insulins have some unique safety and efficacy considerations...
June 2017: Postgraduate Medicine
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