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https://www.readbyqxmd.com/read/29770892/identification-of-n-terminally-truncated-derivatives-of-insulin-analogs-formed-in-pharmaceutical-formulations
#1
Joanna Zielińska, Jacek Stadnik, Anna Bierczyńska-Krzysik, Dorota Stadnik
PURPOSE: Isolation and identification of unknown impurities of recombinant insulin lispro (produced at IBA) formed during accelerated stability testing of pharmaceutical solutions. For comparative purposes also commercially available formulations of recombinant human insulin (Humulin S®; Lilly), recombinant insulin lispro (Humalog®; Lilly), recombinant insulin aspart (NovoRapid® Penfill®; Novo Nordisk), recombinant insulin detemir (Levemir®; Novo Nordisk) and recombinant insulin glargine (Lantus®; Sanofi-Aventis) were analyzed...
May 16, 2018: Pharmaceutical Research
https://www.readbyqxmd.com/read/29730391/pharmacotherapy-for-hyperglycemia-in-pregnancy-the-new-insulins
#2
REVIEW
Yoel Toledano, Eran Hadar, Moshe Hod
Hyperglycemia in pregnancy may lead to adverse maternal, fetal and neonatal outcomes. Tight glycemic control is prudent in order to reduce pregnancy complications. For many years, the gold standard pharmacological therapy during pregnancy was human insulin. Recently, insulin analogues were also introduced to clinical use in pregnancy. This brief review aims to summarize the information on the efficacy and safety of insulin analogue therapy during gestation. The strengths and pitfalls of insulin analogue administration during gestation, compared with human insulin, are presented...
May 3, 2018: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/29656504/efficacy-and-safety-of-myl-1501d-vs-insulin-glargine-in-patients-with-type-1-diabetes-after-52-weeks-results-of-the-instride-1-phase-iii-study
#3
Thomas C Blevins, Abhijit Barve, Bin Sun, Michael Ankersen
AIM: To test the safety and efficacy of MYL-1501D, a proposed insulin glargine biosimilar, in patients with type 1 diabetes mellitus (T1DM). METHODS: The safety and efficacy of MYL-1501D and reference insulin glargine were evaluated in INSTRIDE 1, a 52-week, open-label, randomized, phase III study in patients with T1DM. The primary objective was to determine whether once-daily MYL-1501D was non-inferior to once-daily insulin glargine when administered in combination with mealtime insulin lispro based on change in glycated haemoglobin (HbA1c) from baseline to week 24...
April 15, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29623593/efficacy-and-safety-of-rapid-acting-insulin-analogs-in-special-populations-with-type-1-diabetes-or-gestational-diabetes-systematic-review-and-meta-analysis
#4
REVIEW
Kirsten Nørgaard, Nithya Sukumar, Snorri B Rafnsson, Ponnusamy Saravanan
INTRODUCTION: To assess the efficacy and safety of three available rapid-acting insulin analogs (insulins lispro, aspart and glulisine, respectively) in pregnant women, children/adolescents and people using continuous subcutaneous insulin infusion (CSII) with type 1 diabetes. METHODS: PubMed, EMBASE and Cochrane Reviews were searched electronically, and their bibliographies examined to identify suitable studies for review and inclusion in a meta-analysis. Eligible studies were randomized controlled trials that reported data on relevant clinical outcomes...
April 5, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29596514/characterisation-of-insulin-analogues-therapeutically-available-to-patients
#5
Gary G Adams, Andrew Meal, Paul S Morgan, Qushmua E Alzahrani, Hanne Zobel, Ryan Lithgo, M Samil Kok, David T M Besong, Shahwar I Jiwani, Simon Ballance, Stephen E Harding, Naomi Chayen, Richard B Gillis
The structure and function of clinical dosage insulin and its analogues were assessed. This included 'native insulins' (human recombinant, bovine, porcine), 'fast-acting analogues' (aspart, glulisine, lispro) and 'slow-acting analogues' (glargine, detemir, degludec). Analytical ultracentrifugation, both sedimentation velocity and equilibrium experiments, were employed to yield distributions of both molar mass and sedimentation coefficient of all nine insulins. Size exclusion chromatography, coupled to multi-angle light scattering, was also used to explore the function of these analogues...
2018: PloS One
https://www.readbyqxmd.com/read/29574635/relative-contribution-of-fasting-and-postprandial-blood-glucose-in-overall-glycemic-control-post-hoc-analysis-of-a-phase-iv-randomized-trial
#6
Qing Su, Jun Liu, Pengfei Li, Lei Qian, Wenying Yang
INTRODUCTION: Few prospective clinical trials have investigated the role of fasting blood glucose (FBG) and/or postprandial glucose (PPG) in assessing overall glycemic control by using different insulin regimens. In the present post hoc analysis, we assessed the contribution of FBG and/or PPG in overall glycemic control in Chinese patients under insulin treatment. METHODS: CLASSIFY is a phase IV, randomized, open-label, 26-week, parallel-arm, treat-to-target, multinational, controlled study in patients with type 2 diabetes mellitus to compare the efficacy and safety of insulin lispro mix 25 (LM25) and insulin lispro mix 50 (LM50) as starter insulins...
March 24, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29564932/a-randomized-open-label-comparative-two-period-crossover-trial-on-preference-efficacy-and-safety-profiles-of-a-prefilled-disposable-pen-with-lispro-insulin-u-100-versus-concentrated-lispro-insulin-u-200-in-patients-with-type-2-diabetes-mellitus-a-possible-contribution
#7
Sandro Gentile, Alessandra Fusco, Sara Colarusso, Marco Piscopo, Maria Rosaria Improta, Marco Corigliano, Emilia Martedi, Domenica Oliva, Antonietta Santorelli, Rosa Simonetti, Armando Giammarco, Caterina Colella, Luigia Miretto, Alessandra D'Alessandro, Viviana Russo, Giuseppina Guarino, Giampiero Marino, Gerardo Corigliano, Felice Strollo
BACKGROUND: Incorrect insulin administration techniques may greatly affect metabolic control in T2DM people. The aim of our study was to compare glycemic control associated with a concentrated insulin analog preparation (U-200 lispro) in people with T2DM to the one observed with standard U-100 lispro. METHODS: 126 patients with T2DM were enrolled. Half of them were randomized to U-100 lispro, half to U-200 and after 12 weeks they were switched to the other preparation for 12 weeks...
March 22, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29536605/effects-of-intranasal-insulin-on-endogenous-glucose-production-in-insulin-resistant-men
#8
Changting Xiao, Satya Dash, Priska Stahel, Gary F Lewis
The effects of intranasal insulin on the regulation of endogenous glucose production (EGP) in individuals with insulin resistance were assessed in a single-blind, crossover study. Overweight or obese insulin-resistant men (n = 7; body mass index 35.4 ± 4.4 kg/m2 , homeostatic model assessment of insulin resistance 5.6 ± 1.6) received intranasal spray of either 40 IU insulin lispro or placebo in 2 randomized visits. Acute systemic spillover of intranasal insulin into the circulation was matched with a 30-minute intravenous infusion of insulin lispro in the nasal placebo arm...
March 14, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29527407/transient-neonatal-diabetes-mellitus-in-a-very-preterm-infant-due-to-abcc8-mutation
#9
Barbara Piccini, Caterina Coviello, Livia Drovandi, Artuso Rosangela, Francesca Monzali, Emilio Casalini, Sabrina Giglio, Sonia Toni, Carlo Dani
Neonatal diabetes mellitus (NDM) is a monogenic form of diabetes occurring within 6 months from birth. NDM can be permanent or transient (TNDM). We report the case of a preterm infant with TNDM due to an ABCC8 mutation identified by next-generation sequencing. The pancreatic adenosine triphosphate (ATP)-sensitive K+ (K-ATP) channel is a key regulator of insulin secretion. Gain-of-function mutations in the genes encoding the Kir6.2 (KCNJ11) and SUR1 (ABCC8) subunits of the channel cause neonatal diabetes. The patient was successfully managed with insulin lispro at a 1:100 dilution, drawn up in an insulin pen injector with a 4-mm needle...
January 2018: American Journal of Perinatology Reports
https://www.readbyqxmd.com/read/29520742/effects-of-insulin-lispro-mix-25-and-insulin-lispro-mix-50-on-postprandial-glucose-excursion-in-patients-with-type-2-diabetes-a-prospective-open-label-randomized-clinical-trial
#10
Wei Li, Fan Ping, Lingling Xu, Meicen Zhou, Hongmei Li, Yaxiu Dong, Yuxiu Li
INTRODUCTION: We compared the effects of insulin lispro mix 25 (LM25) and insulin lispro mix 50 (LM50) on postprandial glucose excursion in patients with type 2 diabetes mellitus (T2DM). METHODS: In this randomized, open-label, investigator-initiated trial, 81 T2DM patients treated with premixed human insulin 70/30 (PHI70/30) for more than 90 days were randomly divided into two groups and received a crossover protocol of either LM25 or LM50 twice daily for 16 weeks...
April 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29518094/a-randomized-controlled-trial-based-algorithm-for-insulin-pump-therapy-in-hyperglycemic-patients-early-after-kidney-transplantation
#11
Johannes M Werzowa, Marcus D Säemann, Alexander Mohl, Michael Bergmann, Christopher C Kaltenecker, Wolfgang Brozek, Andreas Thomas, Michael Haidinger, Marlies Antlanger, Johannes J Kovarik, Chantal Kopecky, Peter X K Song, Klemens Budde, Julio Pascual, Manfred Hecking
Treating hyperglycemia in previously non-diabetic individuals with exogenous insulin immediately after kidney transplantation reduced the odds of developing Posttransplantation Diabetes Mellitus (PTDM) in our previous proof-of-concept clinical trial. We hypothesized that insulin-pump therapy with maximal insulin dosage during the afternoon would improve glycemic control compared to basal insulin and standard-of-care. In a multi-center, randomized, controlled trial testing insulin isophane for PTDM prevention, we added a third study arm applying continuous subcutaneous insulin lispro infusion (CSII) treatment...
2018: PloS One
https://www.readbyqxmd.com/read/29513157/use-of-lispro-insulin-for-treatment-of-diabetic-ketoacidosis-in-cats
#12
Eleonora Malerba, Michela Mazzarino, Francesca Del Baldo, Sara Corradini, Gaia Carotenuto, Massimo Giunti, Federico Fracassi
Objectives The aim of this study was to evaluate the efficacy and safety of lispro insulin for the treatment of feline diabetic ketoacidosis (DKA). Times to resolution of hyperglycaemia, ketosis and acidosis were compared between cats treated with continuous rate infusion (CRI) of lispro insulin and cats treated with CRI of regular insulin. Methods Client-owned cats with naturally occurring DKA, newly diagnosed with diabetes mellitus (DM) or already receiving treatment for DM, were included. Diagnosis of DKA involved the presence of at least two clinical signs consistent with DKA (eg, polyuria/polydipsia, anorexia, severe lethargy, vomiting and dehydration), blood glucose (BG) concentration >13...
March 1, 2018: Journal of Feline Medicine and Surgery
https://www.readbyqxmd.com/read/29488399/laboratory-and-benchtop-performance-of-a-mealtime-insulin-delivery-system
#13
Darlene M Dreon, Trevor M Hannon, Brett Cross, Brett J Carter, Nicholas S Mercer, Jason H Nguyen, Andy Tran, Peter A Melendez, Nancy Morales, Jonathan E Nelson, Meng H Tan
BACKGROUND: A basal bolus insulin regimen requires multiple daily insulin injections, which might discourage patient adherence. As a potential solution, a mealtime insulin-delivery system-a 3-day wearable bolus-only patch-was designed to manually administer mealtime insulin discreetly by actuating buttons through clothing, without the need for multiple needle sticks. METHOD: Extensive functional testing of the patch included dose accuracy (from initial fill of the device to empty), pressure-vacuum leak testing, last-dose lockout and occlusion detection (safety alert features that lock the dosing buttons when no insulin is delivered), assessments of insulin drug stability, toxicological risk (including chemical testing), and system biocompatibility...
February 1, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/29462782/utilizing-elisa-plate-based-immunopurification-and-liquid-chromatography-tandem-mass-spectrometry-for-the-urinary-detection-of-short-and-long-acting-human-insulin-analogues
#14
Péter Judák, Peter Van Eenoo, Koen Deventer
The measurement of human insulin and its synthetic analogues in biological matrices has become increasingly important not only in clinical fields but also in doping control. The use of insulin and its analogues have been included in the list of prohibited substances published by the World Anti-Doping Agency (WADA). This study describes a qualitative method for detection of insulin analogues (lispro, aspart, glulisine, glargine, degludec, detemir) in human urine. The sample preparation consists of a preconcentration step using ultrafiltration followed by an immunoaffinity extraction with an antibody precoated ELISA plate...
May 10, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29430801/dulaglutide-1-5-mg-as-an-add-on-option-for-patients-uncontrolled-on-insulin-subgroup-analysis-by-age-duration-of-diabetes-and-baseline-glycated-haemoglobin-concentration
#15
Kevin M Pantalone, Hiren Patel, Maria Yu, Laura Fernández Landó
AIMS: To assess efficacy and safety of dulaglutide 1.5 mg combined with insulin, categorized by subgroups of baseline glycated haemoglobin (HbA1c; ≤9% and >9% [≤74.9 and >74.9 mmol/mol]), age (<65 and ≥65 years), and duration of diabetes (<10 and ≥10 years) at 6 months in patients with type 2 diabetes (T2D). MATERIALS AND METHODS: This pooled analysis was conducted in a population of patients with T2D with similar baseline characteristics who were included in the AWARD-4 and AWARD-9 clinical trials and randomized to dulaglutide 1...
February 12, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29377408/two-year-trial-of-intermittent-insulin-therapy-vs-metformin-for-the-preservation-of-%C3%AE-cell-function-after-initial-short-term-intensive-insulin-induction-in-early-type-2-diabetes
#16
Ravi Retnakaran, Haysook Choi, Chang Ye, Caroline K Kramer, Bernard Zinman
AIMS: To test the hypothesis that "induction" intensive insulin therapy (IIT) needs to be followed by "maintenance therapy" to preserve β-cell function, and to evaluate the impact on β-cell function over 2 years of two approaches to maintenance therapy: intermittent short-term IIT every 3 months vs daily metformin. MATERIALS AND METHODS: In this trial, 24 adults with a mean type 2 diabetes mellitus (T2DM) duration of 2.0 ± 1.7 years and glycated haemoglobin (HbA1c) levels 6...
January 27, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29359575/safety-of-insulin-lispro-and-a-biosimilar-insulin-lispro-when-administered-through-an-insulin-pump
#17
James Thrasher, Howard Surks, Irene Nowotny, Suzanne Pierre, Baerbel Rotthaeuser, Karin Wernicke-Panten, Satish Garg
BACKGROUND: SAR342434 (U100; SAR-Lis; insulin lispro) is a biosimilar/follow-on to insulin lispro (U100; Ly-Lis). Similar pharmacokinetics/pharmacodynamics between the two products has been demonstrated in a hyperinsulinemic euglycemic clamp study. The current study evaluated the safety of SAR-Lis and Ly-Lis when administered by continuous subcutaneous insulin infusion (CSII; insulin pumps). METHODS: This was a randomized, open-label, 2 × 4-week, two-arm crossover study in 27 patients with type 1 diabetes mellitus (NCT02603510)...
January 1, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/29355435/anti-insulin-antibodies-and-adverse-events-with-biosimilar-insulin-lispro-compared-with-humalog-insulin-lispro-in-people-with-diabetes
#18
Philip Home, Karl-Michael Derwahl, Monika Ziemen, Karin Wernicke-Panten, Suzanne Pierre, Yvonne Kirchhein, Satish K Garg
BACKGROUND: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (Humalog® ; Ly-Lis). Two randomized, controlled, open-label, parallel-group, phase 3 studies were conducted to compare the efficacy and safety of SAR-Lis and Ly-Lis, both in combination with insulin glargine (Lantus® ). SORELLA 1 was a 12-month study in 507 people with type 1 diabetes mellitus (T1DM); SORELLA 2 was a 6-month study in 505 people with type 2 diabetes mellitus (T2DM). In this study, the impact of anti-insulin antibodies (AIA) to SAR-Lis and Ly-Lis on safety and glycemic control is reported...
February 2018: Diabetes Technology & Therapeutics
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
#19
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...
January 2018: 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
#20
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
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