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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
#1
Satish 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®; GLA100GLA-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...
July 19, 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
#2
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
#3
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...
July 12, 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
#4
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)...
June 30, 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
#5
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
#6
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
#7
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...
May 30, 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
#8
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
#9
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
https://www.readbyqxmd.com/read/28421968/chronic-toxicology-studies-of-basal-insulin-peglispro-in-rats-and-dogs-a-novel-pegylated-insulin-lispro-analog-with-a-prolonged-duration-of-action
#10
Richard A Byrd, Jamie L Blackbourne, Mary Pat Knadler, Albert E Schultze, John L Vahle
Basal insulin peglispro (BIL) consists of insulin lispro with a 20-kDa polyethylene glycol (PEG) moiety covalently attached to lysine B28. Because chronic parenteral administration of PEGylated proteins to animals has sometimes resulted in PEG vacuolation of tissue macrophages, renal tubular cells, and choroid plexus ependymal cells, we investigated whether chronic subcutaneous (sc) injection of BIL in rats (52 weeks) and dogs (39 weeks) was associated with systemic toxicities or other changes, including vacuolation of tissue macrophages, renal tubular cells, and ependymal cells...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28420259/seasonality-of-insulin-use-in-german-outpatients-with-diabetes-a-retrospective-analysis
#11
Karel Kostev, Sarah Gläser, Louis Jacob
BACKGROUND: Seasonality in insulin sensitivity has been the focus of controversial literature in the past decades. The aim of this study was to analyze seasonality of insulin use in patients with diabetes who were followed in German general practices. METHODS: This study included patients affected by type 1 (T1DM) or type 2 diabetes mellitus (T2DM) who received intensified conventional insulin therapy over a period of at least 12 months between 2013 and 2015. The main outcome was the median insulin dose per day (calculated daily insulin doses, CDDs) between June and August (summer) and between December and February (winter)...
April 1, 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28394405/modeling-pharmacokinetic-profiles-of-insulin-regimens-to-enhance-understanding-of-subcutaneous-insulin-regimens
#12
Lai San Tham, Karen Schneck, Ali Ertekin, Jesus Reviriego
Insulin pharmacokinetics following subcutaneous administration were modeled, simulated, and displayed through an interactive and user-friendly interface to illustrate the time course of administered insulins frequently prescribed, providing a simple tool for clinicians through a straightforward visualization of insulin regimens. Pharmacokinetic data of insulin formulations with different onset and duration of action from several clinical studies, including insulin glargine, regular insulin, neutral protamine Hagedorn (NPH), insulin lispro, and premixed preparations of NPH with regular insulin (Mix 70/30), and insulin lispro protamine suspension with insulin lispro (Mix 50/50, Mix 75/25), were used to develop a predictive population pharmacokinetic model of insulins with consideration of factors such as insulin formulation, weight-based dosing, body-weight effect on volume of distribution, and administration time relative to meals, on the insulin time-action profile...
April 10, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28389158/association-between-mild-and-severe-hypoglycemia-in-people-with-type-2-diabetes-initiating-insulin
#13
Andreas Festa, Simon R Heller, Elizabeth Seaquist, Ran Duan, Irene Hadjiyianni, Haoda Fu
AIMS: Primary objective: Identify risk factors associated with severe hypoglycemia (SH) and investigate the association between mild hypoglycemia and SH in people with type 2 diabetes starting insulin. Secondary objectives: Investigate the association of demographics and clinical factors with SH incidence. METHODS: Integrated trial database data were obtained for 3 randomized controlled trials that included insulin-naïve people with type 2 diabetes initiating basal (insulin glargine) versus biphasic (insulin lispro mixture) insulin...
June 2017: Journal of Diabetes and its Complications
https://www.readbyqxmd.com/read/28371461/comparison-of-morning-basal-1-bolus-insulin-therapy-insulin-glulisine-insulin-glargine-300-u-ml-vs-insulin-lispro-insulin-glargine-biosimilar-using-continuous-glucose-monitoring-a-randomized-crossover-study
#14
Soichi Takeishi, Hiroki Tsuboi, Shodo Takekoshi
INTRODUCTION: We compared the effects of morning administration of insulin glulisine + insulin glargine 300 U/mL (G + G300) with that of insulin lispro + insulin glargine biosimilar (L + GB). MATERIALS AND METHODS: A total of 30 patients with type 2 diabetes who wore a continuous glucose monitoring device on admission after glucose levels were stabilized by morning long-acting and ultra-rapid-acting insulins were randomly allocated to groups who received G + G300 on days 1 and 2, and the same dose L + GB on days 3 and 4, or vice versa...
March 28, 2017: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/28368217/long-acting-insulin-allergy-in-a-diabetic-child
#15
Carla Mastrorilli, Laura Rizzuti, Antonina Marta Cangelosi, Brunella Iovane, Giovanni Chiari, Carlo Caffarelli
Insulin allergy has been uncommon since the introduction of human recombinant insulin preparations; the prevalence is 2.4%. Insulin injection could elicit immediate reactions, which are usually induced by an IgE-mediated mechanism, within the first hour after drug administration. In the present study, we describe the case of a child who experienced immediate urticaria after long-acting insulin injection. A 9-year-old girl affected by type I diabetes mellitus referred a history of three episodes of urticaria 30 min after insulin subcutaneous injection...
April 1, 2017: International Journal of Immunopathology and Pharmacology
https://www.readbyqxmd.com/read/28230457/comparative-effectiveness-of-rapid-acting-insulins-in-adults-with-diabetes
#16
Patrick N Racsa, Yunus Meah, Jeffrey J Ellis, Kimberly R Saverno
BACKGROUND: Although there are a variety of insulin products and new delivery modalities available, the absence of direct clinical and economic comparisons can make treatment planning and formulary decision making difficult. Direct comparisons between insulin aspart and insulin lispro from a large heterogeneous population are not available. OBJECTIVE: To assess differences in clinical outcomes, medication adherence, utilization, and total health care costs between aspart and lispro and vial versus pen modalities for administering these short-acting insulin analogs...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28156005/different-insulin-types-and-regimens-for-pregnant-women-with-pre-existing-diabetes
#17
REVIEW
Sinéad M O'Neill, Louise C Kenny, Ali S Khashan, Helen M West, Rebecca Md Smyth, Patricia M Kearney
BACKGROUND: Insulin requirements may change during pregnancy, and the optimal treatment for pre-existing diabetes is unclear. There are several insulin regimens (e.g. via syringe, pen) and types of insulin (e.g. fast-acting insulin, human insulin). OBJECTIVES: To assess the effects of different insulin types and different insulin regimens in pregnant women with pre-existing type 1 or type 2 diabetes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 October 2016), ClinicalTrials...
February 3, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28133990/economic-outcomes-with-the-conversion-of-insulin-delivery-methods-in-hospitals
#18
Kari A Kelton, Sinem Perk, Scott Loveland, Magaly Perez-Nieves, Haoda Fu, Xiaomei Peng
PURPOSE: To evaluate the insulin wastage and associated acquisition costs when switching from individual patient supply (IPS) of 3-mL pens of rapid-acting insulin (RAI) aspart to floor stock (FS) dispensing of 3-mL vials of RAI lispro, and with conversion from IPS of 3-mL pens to centralized unit dose (CUD) of 10-mL vials of basal insulin detemir. METHODS: Data from September 2010 to December 2012 from three hospitals in the Roper St. Francis Healthcare (RSFH) were used: Roper Hospital (368 beds), Bon Secours St...
February 16, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28029018/exenatide-versus-insulin-lispro-added-to-basal-insulin-in-a-subgroup-of-korean-patients-with-type-2-diabetes-mellitus
#19
Kun Ho Yoon, Elise Hardy, Jenny Han
BACKGROUND: The prevalence of type 2 diabetes mellitus (T2DM) and obesity is increasing in Korea. Clinical studies in patients with T2DM have shown that combining the glucagon-like peptide-1 receptor agonist exenatide twice daily with basal insulin is an effective glucose-lowering strategy. However, these studies were predominantly conducted in non-Asian populations. METHODS: We conducted a subgroup analysis of data from a multinational, 30-week, randomized, open-label trial to compare the effects of exenatide twice daily (n=10) or three times daily mealtime insulin lispro (n=13) among Korean patients with T2DM inadequately controlled (glycosylated hemoglobin [HbA1c] >7...
February 2017: Diabetes & Metabolism Journal
https://www.readbyqxmd.com/read/27988180/factors-associated-with-reaching-or-not-reaching-target-hba1c-after-initiation-of-basal-or-premixed-insulin-in-patients-with-type-2-diabetes
#20
RANDOMIZED CONTROLLED TRIAL
A J Scheen, H Schmitt, H H Jiang, T Ivanyi
AIMS: To evaluate factors associated with reaching or not reaching target glycated haemoglobin (HbA1c) levels by analysing the respective contributions of fasting hyperglycaemia (FHG), also referred to as basal hyperglycaemia, vs postprandial hyperglycaemia (PHG) before and after initiation of a basal or premixed insulin regimen in patients with type 2 diabetes. METHODS: This post-hoc analysis of insulin-naïve patients in the DURABLE study randomised to receive either insulin glargine or insulin lispro mix 25 evaluated the percentages of patients achieving a target HbA1c of <7...
February 2017: Diabetes & Metabolism
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