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https://www.readbyqxmd.com/read/28433560/glycaemic-control-and-hypoglycaemia-with-insulin-glargine-300-u-ml-compared-with-glargine-100-u-ml-in-japanese-adults-with-type-2-diabetes-using-basal-insulin-plus-oral-anti-hyperglycaemic-drugs-edition-jp-2-randomised-12-month-trial-including-6-month-extension
#1
Y Terauchi, M Koyama, X Cheng, M Sumi, M C Riddle, G B Bolli, T Hirose
AIMS: To compare insulin glargine 300 U/mL (Gla-300) with glargine 100 U/mL (Gla-100) in Japanese adults with uncontrolled type 2 diabetes on basal insulin and oral anti-hyperglycaemic drugs over 12 months. METHODS: EDITION JP 2 was a randomised, open-label, phase 3 study. Following a 6-month treatment period, participants continued receiving previously assigned once daily Gla-300 or Gla-100, plus oral anti-hyperglycaemic drugs, in a 6-month extension period. Glycaemic control, hypoglycaemia and adverse events were assessed...
April 19, 2017: Diabetes & Metabolism
https://www.readbyqxmd.com/read/28432746/impact-of-baseline-hba1c-diabetes-duration-and-bmi-on-clinical-outcomes-in-the-lixilan-o-trial-testing-iglarlixi-insulin-glargine-lixisenatide-titratable-fixed-ratio-combination-versus-insulin-glargine-and-lixisenatide-monocomponents
#2
M J Davies, L A Leiter, B Guerci, G Grunberger, F J Ampudia-Blasco, C Yu, W Stager, E Niemoeller, E Souhami, J Rosenstock
To determine whether baseline characteristics impact clinical outcomes in the LixiLan-O trial (N = 1170), the efficacy and safety of iGlarLixi, a titratable fixed-ratio combination of insulin glargine 100 U (iGlar) and lixisenatide (Lixi) was compared with iGlar or Lixi alone in patients with uncontrolled type 2 diabetes mellitus (T2DM) on oral therapy. Subgroups according to baseline glycated haemoglobin (HbA1c; <8%, ≥8% [<64, ≥64 mmol/mol]); T2DM disease duration (<7, ≥7 years) and body mass index (BMI; <30, ≥30 kg/m(2) ) were investigated...
April 22, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28428368/erratum-efficacy-and-safety-of-lixilan-a-titratable-fixed-ratio-combination-of-insulin-glargine-plus-lixisenatide-in-type-2-diabetes-inadequately-controlled-on-basal-insulin-and-metformin-the-lixilan-l-randomized-trial-diabetes-care-2016-39-1972-1980
#3
Vanita R Aroda, Julio Rosenstock, Carol Wysham, Jeffrey Unger, Diego Bellido, Guillermo González-Gálvez, Akane Takami, Hailing Guo, Elisabeth Niemoeller, Elisabeth Souhami, Richard M Bergenstal
No abstract text is available yet for this article.
April 20, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28420696/erratum-benefits-of-lixilan-a-titratable-fixed-ratio-combination-of-insulin-glargine-plus-lixisenatide-versus-insulin-glargine-and-lixisenatide-monocomponents-in-type-2-diabetes-inadequately-controlled-on-oral-agents-the-lixilan-o-randomized-trial-diabetes
#4
Julio Rosenstock, Ronnie Aronson, George Grunberger, Markolf Hanefeld, PierMarco Piatti, Pierre Serusclat, Xi Cheng, Tianyue Zhou, Elisabeth Niemoeller, Elisabeth Souhami, Melanie Davies
No abstract text is available yet for this article.
April 18, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28420259/seasonality-of-insulin-use-in-german-outpatients-with-diabetes-a-retrospective-analysis
#5
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/28417535/rates-of-hypoglycaemia-are-lower-in-patients-treated-with-insulin-degludec-liraglutide-ideglira-than-with-ideg-or-insulin-glargine-regardless-of-the-hypoglycaemia-definition-used
#6
P Norwood, R Chen, E Jaeckel, I Lingvay, H Jarlov, L Lehmann, S Heller
AIMS: The rates of hypoglycaemia reported in clinical trials are affected by the definitions of hypoglycaemia used. This post-hoc analysis took data from two trials comparing the once-daily, fixed ratio combination of insulin degludec/liraglutide (IDegLira) with basal insulin regimens, and re-analysed these data using alternative hypoglycaemia definitions and stratified outcomes by dosing time and baseline characteristics. MATERIALS AND METHODS: Post hoc analyses of the DUAL I (patients uncontrolled on oral antidiabetic drugs) and DUAL V (patients uncontrolled on insulin glargine (IGlar) U100) trials were carried out using different definitions of hypoglycaemia and by whether treatments were administered in the AM or PM...
April 17, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28407415/impact-of-insulin-glargine-and-lixisenatide-on-beta-cell-function-in-patients-with-type-2-diabetes-mellitus-a-randomized-open-label-study
#7
Juris J Meier, Nina Schenker, Melanie Kahle, Freimut Schliess, Christoph Kapitza, Bjoern A Menge
Beta-cell function can be enhanced by direct stimulation of insulin secretion or by induction of beta-cell rest. Whether both strategies can complement each other has not yet been examined. 28 subjects with type 2 diabetes (HbA1c 7.8 ± 0.5 %) were treated with either lixisenatide or titrated insulin glargine, followed by their combined administration each over four weeks. First and second phase insulin secretion during an i.v. glucose challenge were calculated. First- and second-phase insulin secretion were not increased with glargine alone, but increased after addition of lixisenatide (p < 0...
April 13, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28403644/the-effect-of-basal-insulin-glargine-on-the-fibrinolytic-system-and-von-willebrand-factor-in-people-with-dysglycaemia-and-high-risk-for-cardiovascular-events-swedish-substudy-of-the-outcome-reduction-with-an-initial-glargine-intervention-trial
#8
Aslak Rautio, Kurt Boman, Hertzel C Gerstein, Jenny Hernestål-Boman, Shun Fu Lee, Mona Olofsson, Linda Garcia Mellbin
INTRODUCTION: Fibrinolytic factors, plasminogen activator inhibitor-1, tissue plasminogen activator, tissue plasminogen activator/plasminogen activator-complex and the haemostatic factor von Willebrand factor are known markers of cardiovascular disease. Their plasma levels are adversely affected in patients with dysglycaemia, and glucose normalization with insulin glargine might improve the levels of these factors. METHODS: Prespecified Swedish substudy of the Outcome Reduction with an Initial Glargine Intervention trial (ClinicalTrials...
April 1, 2017: Diabetes & Vascular Disease Research
https://www.readbyqxmd.com/read/28394405/modeling-pharmacokinetic-profiles-of-insulin-regimens-to-enhance-understanding-of-subcutaneous-insulin-regimens
#9
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/28394183/assessing-the-impact-of-insulin-glargine-and-detemir-treatment-to-serum-total-igf1-levels-in-the-insulin-naive-type-2-diabetic-patients
#10
Soner Cander, Ozen Oz Gul, Oguzhan Sitki Dizdar, Nizameddin Koca, Taner Aydın, Emre Sarandol, Canan Ersoy
AIM: The mitogenic potential of analog insulins due to their different insulin-like growth factor-1 (IGF1) receptor affinity is a situation that causes concern related to cancer risk. We aimed to examine the changes in the serum IGF1 levels formed by insulin glargine and detemir in the insulin-naive type 2 diabetic patients. METHODS: The serum total IGF1 levels of the 62 insulin-naive type 2 diabetic patients were studied before and after 12 weeks of the started treatment with basal insulin analogs...
April 10, 2017: Metabolic Syndrome and related Disorders
https://www.readbyqxmd.com/read/28389158/association-between-mild-and-severe-hypoglycemia-in-people-with-type-2-diabetes-initiating-insulin
#11
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/28386990/consistent-findings-in-glycaemic-control-body-weight-and-hypoglycaemia-with-iglarlixi-insulin-glargine-lixisenatide-titratable-fixed-ratio-combination-versus-insulin-glargine-across-baseline-hba1c-bmi-and-diabetes-duration-categories-in-the-lixilan-l-trial
#12
C Wysham, R C Bonadonna, V R Aroda, M Puig-Domingo, C Kapitza, W Stager, C Yu, E Niemoeller, E Souhami, R M Bergenstal
AIM: To assess the impact of baseline characteristics on clinical outcomes in the LixiLan-L trial, a randomized open-label trial designed to evaluate the efficacy and safety of iGlarLixi, a novel fixed-ratio combination of insulin glargine 100 U (iGlar) plus lixisenatide, in comparison with iGlar over 30 weeks in a population of patients with type 2 diabetes mellitus (T2DM) inadequately controlled on a previous regimen of basal insulin alone or in combination with one or two oral glucose-lowering drugs...
April 6, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28371567/an-open-label-randomized-study-comparing-basal-insulin-peglispro-and-insulin-glargine-in-combination-with-oral-antihyperglycemic-medications-in-insulin-na%C3%A3-ve-asian-patients-with-type-2-diabetes
#13
Takahisa Hirose, Zhihong Cai, Kwee Poo Yeo, Makoto Imori, Kenji Ohwaki, Takeshi Imaoka
INTRODUCTION: This phase 3, randomized, open-label study compared efficacy and safety of basal insulin peglispro with insulin glargine after 26 weeks of treatment when added to oral antihyperglycemic medications in insulin-naïve Asian patients with type 2 diabetes (T2D). MATERIALS AND METHODS: The primary objective was to show noninferiority in change from baseline to 26 weeks in glycated hemoglobin. RESULTS: At 26 weeks, insulin peglispro was noninferior to glargine, meeting the primary objective...
March 31, 2017: Journal of Diabetes Investigation
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
#14
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/28368516/validation-of-the-origin-cardiovascular-biomarker-panel-and-the-value-of-adding-troponin-i-in-dysglycemic-people
#15
Hertzel C Gerstein, Guillaume Paré, Matthew J McQueen, Shun Fu Lee, Sibylle Hess
Background: Analyses of stored blood from the ORIGIN trial (Outcomes Reduction with an Initial Glargine Intervention) identified biomarkers that supplemented clinical risk factors for cardiovascular (CV) events or death. Their performance in participants with diabetes in the Heart Outcomes Prevention Evaluation (HOPE) study, and the incremental value of adding high sensitivity troponin I (hsTnI) in the ORIGIN study was assessed. Methods: Levels of the 10 ORIGIN biomarkers for the composite cardiovascular outcome of myocardial infarction, stroke or CV death were measured in 350 HOPE study participants with diabetes and stored serum that included all 77 who experienced this outcome...
March 24, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28368217/long-acting-insulin-allergy-in-a-diabetic-child
#16
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/28367916/analysis-of-efficacy-and-safety-of-dulaglutide-0-75-mg-stratified-by-sex-in-patients-with-type-2-diabetes-in-2-randomized-controlled-phase-3-studies-in-japan
#17
Yukiko Onishi, Tomonori Oura, Akiko Matsui, Jun Matsuura, Noriyuki Iwamoto
We analyzed the efficacy and safety of once weekly dulaglutide 0.75 mg by sex in 2 randomized, controlled phase 3 studies in Japanese patients with type 2 diabetes (a 52-week monotherapy study [comparator liraglutide 0.9 mg] and a 26-week combination therapy study [comparator insulin glargine]). Females comprised 18% of patients in the monotherapy study and 29% of patients in the combination therapy study. Mean reductions from baseline in glycated hemoglobin (HbA1c) were similar between the sexes for dulaglutide- and liraglutide-treated patients (range -1...
March 29, 2017: Endocrine Journal
https://www.readbyqxmd.com/read/28366602/clinical-outcomes-of-switching-from-insulin-glargine-to-nph-insulin-in-indigent-patients-at-a-charitable-pharmacy-the-charitable-insulin-nph-care-for-the-indigent-cinci-study
#18
Russell Curington, Mike Espel, Pamela C Heaton, Heidi Luder, Bethanne Brown
OBJECTIVES: To assess the clinical outcomes of indigent patients with type 2 diabetes served by a charitable pharmacy after therapy change from insulin glargine to NPH insulin. DESIGN: This was a 24-week prospective pilot study. SETTING: Community charitable pharmacy. PARTICIPANTS: Underserved, financially disadvantaged adults with type 2 diabetes. INTERVENTION: Conversion from insulin glargine to NPH insulin...
March 30, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28361463/clinical-outcomes-of-patients-with-diabetes-who-exhibit-upper-quartile-insulin-antibody-responses-after-treatment-with-ly2963016-or-lantus-%C3%A2-insulin-glargine
#19
Liza L Ilag, Timothy M Costigan, Mark A Deeg, Robyn K Pollom, Curtis L Chang, Robert J Konrad, Melvin J Prince
INTRODUCTION: We compared insulin antibody response (IAR) profiles in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who received LY2963016 insulin glargine (LY IGlar) or Lantus(®) insulin glargine (IGlar) and evaluated the potential relationship between higher IARs and clinical and safety outcomes with a focus on patients who exhibited antibody responses in the upper quartile. METHODS: Data from ELEMENT-1 (52-week open-label in T1D) and ELEMENT-2 (24-week, double-blind study in T2D) were analyzed...
March 30, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28357772/switch-to-combined-glp1-receptor-agonist-lixisenatide-with-basal-insulin-glargine-in-poorly-controlled-t2dm-patients-with-premixed-insulin-therapy-a-clinical-observation-and-pilot-study-in-nine-patients
#20
Jürgen Harreiter, Lana Kosi-Trebotic, Albert Lukas, Peter Wolf, Yvonne Winhofer, Anton Luger, Alexandra Kautzky-Willer, Michael R Krebs
INTRODUCTION: To prove the feasibility and safety of a conversion to once-daily injected GLP1 agonist (lixisenatide) and long-acting basal insulin analogue (glargine) in patients with T2DM and poorly controlled glycemia previously treated with multiple injections of premixed insulins (iPremix) in an outpatient setting. METHODS: Nine patients with T2DM currently receiving iPremix formulations and poor glycemic control were switched to once-daily injected lixisenatide (Lixi) and basal insulin analogue glargine (iGlar) for a 12-week period...
March 29, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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