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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
#1
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
#2
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
#3
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
#4
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...
January 20, 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-cgm-a-randomized-crossover-study
#5
Soichi Takeishi, Hiroki Tsuboi, Shodo Takegoshi
AIMS/INTRODUCTION: We compared the effects of morning administration of insulin glulisine + insulin glargine 300 U/ml (G+G300) to that of insulin lispro + insulin glargine biosimilar (L+GB). MATERIALS AND METHODS: 30 patients with type 2 diabetes who wear continuous glucose monitoring device in 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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/27987252/similar-pharmacokinetics-and-pharmacodynamics-of-rapid-acting-insulin-lispro-products-sar342434-and-us-and-eu-approved-humalog-in-subjects-with-type-1-diabetes
#12
Christoph Kapitza, Irene Nowotny, Anne Lehmann, Karin Bergmann, Baerbel Rotthaeuser, Leszek Nosek, Reinhard H A Becker
AIM: To compare the pharmacokinetics (PK) and pharmacodynamics (PD) of 3 rapid-acting insulin lispro products: SAR342434 solution, United States (US)-approved Humalog and European Union (EU)-approved Humalog. METHODS: In a single-centre, randomized, double-blind, 3-treatment, 3-period, 6-sequence, crossover, euglycaemic clamp study (NCT02273258), adult male subjects with type 1 diabetes were randomized to receive 0.3 U/kg of SAR342434 solution, US-approved and EU-approved Humalog under fasted conditions...
December 17, 2016: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27964837/efficacy-of-sitagliptin-for-the-hospital-management-of-general-medicine-and-surgery-patients-with-type-2-diabetes-sita-hospital-a-multicentre-prospective-open-label-non-inferiority-randomised-trial
#13
Francisco J Pasquel, Roma Gianchandani, Daniel J Rubin, Kathleen M Dungan, Isabel Anzola, Patricia C Gomez, Limin Peng, Israel Hodish, Tim Bodnar, David Wesorick, Vijay Balakrishnan, Kwame Osei, Guillermo E Umpierrez
BACKGROUND: The role of incretin-based drugs in the treatment of patients with type 2 diabetes admitted to hospital has not been extensively assessed. In this study, we compared the safety and efficacy of a dipeptidyl peptidase-4 inhibitor (sitagliptin) plus basal insulin with a basal-bolus insulin regimen for the management of patients with type 2 diabetes in general medicine and surgery in hospitals. METHODS: We did a multicentre, prospective, open-label, non-inferiority randomised clinical trial (Sita-Hospital) in five hospitals in the USA, enrolling patients aged 18-80 years with type 2 diabetes and a random blood glucose concentration of 7·8-22·2 mmol/L who were being treated with diet or oral antidiabetic drugs or had a total daily insulin dose of 0·6 units per kg or less, admitted to general medicine and surgery services...
February 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/27905149/scope-and-limitations-of-fmoc-chemistry-spps-based-approaches-to-the-total-synthesis-of-insulin-lispro-via-ester-insulin
#14
Balamurugan Dhayalan, Kalyaneswar Mandal, Nischay Rege, Michael A Weiss, Simon H Eitel, Thomas Meier, Ralph O Schoenleber, Stephen B H Kent
We have systematically explored three approaches based on 9-fluorenylmethoxycarbonyl (Fmoc) chemistry solid phase peptide synthesis (SPPS) for the total chemical synthesis of the key depsipeptide intermediate for the efficient total chemical synthesis of insulin. The approaches used were: stepwise Fmoc chemistry SPPS; the "hybrid method", in which maximally protected peptide segments made by Fmoc chemistry SPPS are condensed in solution; and, native chemical ligation using peptide-thioester segments generated by Fmoc chemistry SPPS...
January 31, 2017: Chemistry: a European Journal
https://www.readbyqxmd.com/read/27860499/premixed-insulin-analogue-compared-with-basal-plus-regimen-for-inpatient-glycemic-control
#15
Abraham Edgar Gracia-Ramos, María Del Pilar Cruz-Domínguez, Eduardo Osiris Madrigal-Santillán, José Antonio Morales-González, Eduardo Madrigal-Bujaidar, José Leopoldo Aguilar-Faisal
BACKGROUND: No previous studies have investigated the use of a premixed insulin analogue in a hospital setting. OBJECTIVE: To compare the efficacy and safety of treatment with premixed insulin analogue (insulin lispro mix 75/25, LM75/25) with the basal-plus regimen with insulin glargine in hospitalized patients with type 2 diabetes (T2D). MATERIALS AND METHODS: A randomized clinical trial in hospitalized patients with T2D and glucose >140 mg/dL on admission was performed...
November 2016: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/27776251/the-effects-of-exenatide-twice-daily-compared-to-insulin-lispro-added-to-basal-insulin-in-latin-american-patients-with-type-2-diabetes-a-retrospective-analysis-of-the-4b-trial
#16
RANDOMIZED CONTROLLED TRIAL
Silvia Beatriz Gorban de Lapertosa, Gustavo Frechtel, Elise Hardy, Leobardo Sauque-Reyna
AIMS: Socioeconomic changes in Latin American countries have led to an increased prevalence of type 2 diabetes (T2D). We examined the effects of exenatide twice daily (BID) or insulin lispro, each added to insulin glargine, in Latin American patients with T2D. METHODS: This was a subgroup analysis of patients from Argentina and Mexico in the 4B study (N=114). Patients with glycated hemoglobin (HbA1c) of 7.0-10.0% (53-86mmol/mol) after 12weeks of intensive basal insulin optimization were randomized to exenatide BID or thrice-daily insulin lispro added to insulin glargine and metformin...
December 2016: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/27660663/insulin-lispro-low-mixture-twice-daily-vs-basal-insulin-glargine-once-daily-and-prandial-insulin-lispro-once-daily-as-insulin-intensification-strategies-in-patients-with-type-2-diabetes-latin-american-subpopulation-analysis-of-a-randomized-trial
#17
Arturo Rojas, Georgina Sposetti, Jorge L Gross, Douglas Eugenio Barbieri, Ran Duan, Bruno Linetzky, Janaina Martins De Lana, Oded Stempa, Angel Rodriguez
BACKGROUND: This post hoc analysis examined the efficacy and safety of twice-daily insulin lispro low mixture (LM25) and once-daily basal insulin glargine plus once-daily prandial insulin lispro (IGL) in a Latin American subpopulation with type 2 diabetes mellitus (T2DM). METHODS: A phase 4, randomized, open-label, parallel-arm trial included participants aged 18-75 years with T2DM taking once-daily insulin glargine and stable doses of metformin and/or pioglitazone with glycated hemoglobin (HbA1c) 7...
2016: Diabetology & Metabolic Syndrome
https://www.readbyqxmd.com/read/27563254/comparison-of-efficacy-and-safety-of-two-starting-insulin-regimens-in-non-asian-asian-indian-and-east-asian-patients-with-type-2-diabetes-a-post-hoc-analysis-of-the-paradigm-study
#18
Linong Ji, Kyung Wan Min, Juliana Oliveira, Thomas Lew, Ran Duan
OBJECTIVE: The objective of this study was to explore the efficacy and safety of insulin lispro mix 25 (25% insulin lispro and 75% insulin lispro protamine suspension [LM25]) or insulin glargine plus insulin lispro (G+L) in insulin-naïve patients with type 2 diabetes from different racial/ethnic groups. METHODS: Three subgroups from the PARADIGM study were analyzed post hoc: non-Asian (n=130), Asian Indian (n=106), and East Asian (n=89). RESULTS: All subgroups recorded glycated hemoglobin (HbA1c) reductions: non-Asian (LM25, -2...
2016: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
https://www.readbyqxmd.com/read/27553192/an-assessment-of-the-central-disposition-of-intranasally-administered-insulin-lispro-in-the-cerebrospinal-fluid-of-healthy-volunteers-and-beagle-dogs
#19
Stephen Lowe, Emanuele Sher, Graham Wishart, Kimberley Jackson, Eunice Yuen, Claire Brittain, Siew Chinn Fong, David O Clarke, William H Landschulz
Intranasally administered regular insulin and insulin aspart have shown cognitive benefit for patients with Alzheimer's disease (AD). To support development of intranasally administered insulin analogs for AD, the central disposition of intranasal insulin lispro in the cerebrospinal fluid (CSF) of healthy volunteers was investigated. Healthy volunteers (N = 8) received two sequential doses of intranasal insulin lispro (48 or 80 IU followed by 160 IU) by Aero Pump in an open-label, single-period study with serial CSF and serum sampling over 5 hours after each dose...
August 23, 2016: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/27540462/treatment-with-insulin-analogs-especially-glargine-and-lispro-associates-with-better-renal-function-and-higher-hemoglobin-levels-in-type-1-diabetic-patients-with-impaired-kidney-function
#20
Christoph Hasslacher, Felix Kulozik, Justo Lorenzo Bermejo
OBJECTIVES: The influence of type of insulin treatment - insulin analogs versus human insulin - on the development of diabetes related vascular complications has been sparsely investigated. We examine here possible differences regarding kidney function and hemoglobin levels. METHODS: Multiple linear regression was used to investigate the relationship between the following characteristics measured in 509 type 1 diabetic patients who were recruited in an outpatient practice: current clinical status and treatment modalities, type of injected insulin and the routine laboratory parameters hemoglobin, HbA1c, serum creatinine, eGFR, hs CRP and urinary albumin/creatinine ratio...
August 2016: Therapeutic Advances in Endocrinology and Metabolism
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