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Insuline Glargin

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https://www.readbyqxmd.com/read/28817342/hypoglycemia-risk-related-to-double-dose-is-markedly-reduced-with-basal-insulin-peglispro-versus-insulin-glargine-in-patients-with-type-2-diabetes-mellitus-in-a-randomized-trial-imagine-8
#1
Cynthia Harris, Thomas Forst, Tim Heise, Leona Plum-Mörschel, Elaine Watkins, Qianyi Zhang, Ludi Fan, Parag Garhyan, Niels Porksen
BACKGROUND: Basal insulin peglispro (BIL) has a peripheral-to-hepatic distribution of action that resembles endogenous insulin and a prolonged duration of action with a flat pharmacokinetic/pharmacodynamic profile at steady state, characteristics that tend to reduce hypoglycemia risk compared to insulin glargine (GL). The primary objective was to demonstrate that clinically significant hypoglycemia (blood glucose ≤54 mg/dL [3.0 mmol/L] or symptoms of severe hypoglycemia) occurred less frequently within 84 h after a double dose (DD) of BIL than a DD of GL...
August 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28817248/attenuated-suppression-of-lipolysis-explains-increases-in-triglyceride-secretion-and-concentration-with-basal-insulin-peglispro-bil-relative-to-insulin-glargine-treatment-in-patients-with-type-1-diabetes
#2
Rakel Fuglsang Johansen, Esben Søndergaard, Helle Linnebjerg, Parag Garhyan, Eric Chen Quin Lam, Niels Porksen, Scott J Jacober, Søren Nielsen
AIMS: In patients with type 1 diabetes, basal insulin peglispro (BIL) lowers weight and increases plasma triglycerides (TG) and hepatic fat relative to insulin glargine (GL). To explain this, we hypothesised that BIL's attenuated peripheral effects may include increased free fatty acid flux to the liver, causing increased VLDL-TG secretion and lipid oxidation, and decreased TG adipose tissue deposition. MATERIALS AND METHODS: In this open-label, randomised, 2-period crossover study, 14 patients with type 1 diabetes received once-daily, individualised, stable BIL or GL doses for 3 weeks...
August 17, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28817223/single-dose-euglycemic-clamp-studies-demonstrating-pharmacokinetic-and-pharmacodynamic-similarity-between-mk-1293-insulin-glargine-and-originator-insulin-glargine-lantus-in-type-1-diabetes-and-healthy-subjects
#3
Michael Crutchlow, John S Palcza, Kate M Mostoller, Chantal D Mahon, April M Barbour, Michael C Marcos, Yang Xu, Elaine Watkins, Linda Morrow, Marcus Hompesch
AIMS: MK-1293 is an insulin glargine that has an identical amino acid sequence to that of Lantus, the originator insulin glargine. Two euglycemic clamp studies, one in subjects with Type 1 diabetes (T1D) and one in healthy subjects, were conducted to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between MK-1293 and Lantus commercially procured in both the European Union (EU-Lantus) and United States (US-Lantus). MATERIALS AND METHODS: Both studies were single-dose, randomized, double-blind, single-center, crossover studies with ≥7 days between dosing periods...
August 17, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28803820/titration-a-randomized-study-to-assess-2-treatment-algorithms-with-new-insulin-glargine-300-units-ml
#4
Jean-François Yale, Lori Berard, Mélanie Groleau, Pasha Javadi, John Stewart, Stewart B Harris
OBJECTIVE: It was uncertain whether an algorithm that involves increasing insulin dosages by 1 unit/day may cause more hypoglycemia with the longer-acting insulin glargine 300 units/mL (GLA-300). The objective of this study was to compare safety and efficacy of 2 titration algorithms, INSIGHT and EDITION, for GLA-300 in people with uncontrolled type 2 diabetes mellitus, mainly in a primary care setting. METHODS: This was a 12-week, open-label, randomized, multicentre pilot study...
August 10, 2017: Canadian Journal of Diabetes
https://www.readbyqxmd.com/read/28803366/does-hypoglycaemia-affect-the-improvement-in-qol-after-the-transition-to-insulin-in-people-with-type-2-diabetes
#5
T H Wieringa, M de Wit, J W R Twisk, F J Snoek
PURPOSE: Quality of Life (QoL) of insulin-naïve people with type 2 diabetes mellitus (T2DM) improves after transition to insulin. Little is known about the role of hypoglycaemia in this context. Secondary analyses of the Study of the Psychological Impact in Real care of Initiating insulin glargine Treatment (SPIRIT) aimed to investigate the relationship between hypoglycaemia and QoL when transitioning to insulin. METHODS: Insulin-naïve Dutch people with T2DM in suboptimal glycaemic control (HbA1c >53 mmol/mol; 7...
August 12, 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28792170/consensus-on-basal-insulin-in-the-management-of-type-2-diabetes-which-when-and-how
#6
Samit Ghosal, Binayak Sinha, Anirban Majumder, Ashok Kumar Das, Awadhesh Kumar Singh, Biswajit Ghoshdastidar, Debasish Maji, Ghanshyam Goyal, Jagat Jyoti Mukherjee, Kalyan Kumar Gangopadhyay, Mathew John, Sanjay Chatterjee, Shalini Jaggi, Subir Ray, Sujoy Majumdar, Surendra Kumar Sharma
INTRODUCTION: Type 2 diabetes mellitus (T2DM) has attained epidemic proportions and continues to increase despite the availability of a number of oral antidiabetic medications and major advances made in insulin delivery since its discovery nearly a hundred years ago. One, amongst many other reasons responsible for the inability to achieve adequate glycaemic control in a substantial proportion of T2DM patients is the delayed initiation and inappropriate intensification of insulin treatment...
July 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/28770464/long-term-follow-up-in-a-girl-with-cystic-fibrosis-and-diabetes-since-the-first-year-of-life
#7
Valentina Fattorusso, Alida Casale, Valeria Raia, Enza Mozzillo, Adriana Franzese
Diabetes mellitus is the most common comorbidity in cystic fibrosis (CF). Recently, more attention has been paid to early glucose metabolism derangements (GMDs). The subject of this report is a female patient, affected by CF since 3 months of age. She presented with intermittent diabetes during early childhood. At the age of 10 years, oral glucose tolerance test (OGTT) was performed and showed glucose intolerance (IGT) status; glargine insulin therapy was started. At the age of 13 years, CF-related diabetes with fasting hyperglycemia occurred, so rapid insulin at meals was added...
August 2, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28766502/transient-neonatal-diabetes-due-to-a-mutation-in-kcnj11-in-a-child-with-klinefelter-syndrome
#8
Amanda Dahl, Radhika Dhamija, Alaa Al Nofal, Siobhan Pittock, Frederick Schwenk, Seema Kumar
Klinefelter syndrome is the most frequent chromosomal aneuploidy in males occurring in about 1 in 660 males. Epidemiological studies have demonstrated increased risk of type 1 diabetes and type 2 diabetes in adults with Klinefelter syndrome. There is only one previous report of neonatal diabetes in a patient with Klinefelter syndrome. We report transient neonatal diabetes due to a pathogenic heterozygous variant in KCNJ11 in a male infant with Klinefelter syndrome. A 78 day old male infant was noted to have sustained hyperglycemia with serum glucose ranging between 148 mg/dL (8...
August 2, 2017: Journal of Clinical Research in Pediatric Endocrinology
https://www.readbyqxmd.com/read/28741967/iglarlixi-a-titratable-once-daily-fixed-ratio-combination-of-basal-insulin-and-lixisenatide-for-intensifying-type-2-diabetes-management-for-patients-inadequately-controlled-on-basal-insulin-with-or-without-oral-agents
#9
Neil Skolnik, Renell S Dupree, Eric L Johnson
BACKGROUND: Achieving and maintaining glycemic control is important for people with type 2 diabetes (T2D) in order to reduce disease-related complications and mortality; however, about half of US patients fail to meet glycemic targets. iGlarLixi, a titratable fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide for once-daily administration, was recently approved by the US Food and Drug Administration for use in adults with T2D inadequately controlled on basal insulin (<60 U daily) or lixisenatide...
July 25, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28736942/glycaemic-control-and-hypoglycaemia-in-people-with-type-2-diabetes-switching-from-twice-daily-basal-insulin-to-once-daily-insulin-glargine-300-u-ml-or-insulin-glargine-100-u-ml-edition-1-and-edition-2-subgroup-analysis
#10
Ronan Roussel, Michael C d'Emden, Miles Fisher, Francisco Javier Ampudia-Blasco, Peter Stella, Florence Bizet, Anna M G Cali, Carol H Wysham
This post hoc analysis compared glycaemic control and hypoglycaemia between insulin glargine 300 U/mL (Gla-300) and glargine 100 U/mL (Gla-100) administered once daily (QD) in people with T2DM from the EDITION 1 (basal plus mealtime insulin) and EDITION 2 (basal insulin plus oral antihyperglycaemic drugs) trials previously receiving twice-daily (BID) insulin. At randomisation, 16.9% and 20.0% of people in EDITION 1 and 2, respectively, were receiving BID basal insulin. HbA1c change from baseline to month 6 was comparable over 6 months with Gla-300 or Gla-100 (LS mean difference -0...
July 24, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28724420/legal-access-to-medications-a-threat-to-brazil-s-public-health-system
#11
Ana Luiza Chieffi, Rita De Cassia Barata Barradas, Moisés Golbaum
BACKGROUND: In Brazil, health is fundamental human right guaranteed by the Constitution of 1988, which created the Brazilian Universal Health System (Sistema Único de Saúde - SUS). The SUS provides medications for outpatient care via policy of pharmaceutical assistance (PA) programmes. Despite the advances in PA policies which include the improvement in access to medications, there has been a significant increase in lawsuits related to health products and services. This study aimed to characterize the medication processes filed between 2010 and 2014 against the Secretary of State for Health of São Paulo (State Health Department of São Paulo - SES/SP), in Brazil, following PA policies...
July 19, 2017: BMC Health Services Research
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 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/28721686/rationale-for-initiation-and-titration-of-the-basal-insulin-glp-1ra-fixed-ratio-combination-products-ideglira-and-iglarlixi-for-the-management-of-type-2-diabetes
#13
REVIEW
Virginia Valentine, Jennifer Goldman, Jay H Shubrook
Type 2 diabetes (T2D) is a progressive disease affecting glucose regulation and a major cause of morbidity and mortality globally. Many patients are not escalated up the treatment ladder appropriately despite failing to achieve glycemic control, with barriers such as fear of hypoglycemia, weight gain, and treatment burden recognized as factors. Exogenous basal insulin is titrated to address control of fasting plasma glucose and may preserve residual β-cell function, thus promoting a greater endogenous prandial insulin response...
August 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28721081/insulin-glargine-300-u-ml-for-basal-insulin-therapy-in-type-1-and-type-2-diabetes-mellitus
#14
REVIEW
Ip Tim Lau, Ka Fai Lee, Wing Yee So, Kathryn Tan, Vincent Tok Fai Yeung
OBJECTIVE: To review published clinical studies on the efficacy and safety of new insulin glargine 300 units/mL (Gla-300), a new long-acting insulin analog, for the treatment of type 1 and type 2 diabetes mellitus (T1DM, T2DM). MATERIALS AND METHODS: Data sources comprised primary research articles on Gla-300, including pharmacodynamic, pharmacokinetic, and clinical studies. RESULTS: In pharmacodynamic and pharmacokinetic studies, Gla-300 showed a flatter time-action profile and longer duration of action than Gla-100...
2017: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
https://www.readbyqxmd.com/read/28692306/development-and-validation-of-an-electrochemiluminescent-elisa-for-quantitation-of-oral-insulin-tregopil-in-diabetes-mellitus-serum
#15
Shilpa G Ramaswamy, Vivek G Nayak, Sumit Kumar Jha, Vishika Hegde, Vinit S Waichale, Ramakrishnan Melarkode, Narendra Chirmule, Anita U Rao, Nilanjan Sengupta
AIM: Tregopil, a novel PEGylated human insulin is in clinical development for oral delivery in diabetes treatment. The aim of the study was to develop and validate a sensitive and specific ELISA method for quantitating Tregopil in diabetes subjects on basal Glargine, since most commercially available insulin kits either do not detect Tregopil or show significant reactivity to Glargine. METHODS: An electrochemiluminescent ELISA was developed and validated for Tregopil quantitation in diabetes serum...
July 10, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28685515/predetermined-anti-diabetic-drug-regimen-adjustments-during-ramadan-fasting-an-observational-study-of-safety
#16
Abdallah M Beano, Mohammad A Zmaili, Zaid H Gheith, Ahmad M Naser, Munther S Momani, Al Motassem F Yousef, Ayman A Zayed
BACKGROUND: Many Muslim type 2 diabetes mellitus (T2DM) patients choose to fast the month of Ramadan despite the possible adverse health effects brought about by the change in dietary habits, among other things. Clinical data regarding the safety of multi-drug regimens during fasting are particularly scarce. The aim of the study was to evaluate the safety of a drug protocol devised by the authors to accommodate Ramadan's dietary changes, involving dose adjustments of four anti-diabetic drug regimens in T2DM patients fasting Ramadan...
June 2017: Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28683300/three-year-data-from-5-harmony-phase-3-clinical-trials-of-albiglutide-in-type-2-diabetes-mellitus-long-term-efficacy-with-or-without-rescue-therapy
#17
Philip D Home, Bo Ahrén, Jane E B Reusch, Marc Rendell, Peter N Weissman, Deborah T Cirkel, Diane Miller, Philip Ambery, Molly C Carr, Michael A Nauck
AIMS: Diabetes therapies that provide durable glycaemic control for people with type 2 diabetes mellitus (T2DM) are needed. We present efficacy results of albiglutide, a glucagon-like peptide-1 receptor agonist, in people with T2DM over a 3-year period. METHODS: Five of the 8 HARMONY phase 3 trials, comparing albiglutide with other therapies or placebo across a spectrum of clinical care, lasted for a preplanned 3years. Participants with uncontrolled hyperglycaemia who met predetermined criteria could receive rescue medication...
June 15, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/28683239/comparison-of-efficacy-and-safety-of-glargine-and-detemir-insulin-in-the-management-of-inpatient-hyperglycemia-and-diabetes
#18
Rodolfo J Galindo, Georgia M Davis, Maya Fayfman, David Reyes-Umpierrez, David Alfa, Limin Peng, Ronald Tamler, Francisco J Pasquel, Guillermo E Umpierrez
OBJECTIVE: Glargine and detemir insulin are the two most commonly prescribed basal insulin analogs for the ambulatory and inpatient management of diabetes. The efficacy and safety of basal insulin analogs in the hospital setting has not been established. METHODS: This observational study compared differences in glycemic control and outcomes in non-ICU patients with blood glucose (BG) >140 mg/dl who were treated with glargine or detemir, between 01/01/2012 and 09/30/2015 in two academic centers...
July 6, 2017: Endocrine Practice
https://www.readbyqxmd.com/read/28674957/a-review-of-the-long-term-efficacy-tolerability-and-safety-of-exenatide-once-weekly-for-type-2-diabetes
#19
REVIEW
Stefano Genovese, Edoardo Mannucci, Antonio Ceriello
INTRODUCTION: Exenatide once weekly (ExeOW, Bydureon(®), Astra Zeneca), a drug belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists, is the first agent approved for treatment of type 2 diabetes (T2D) that can be administered on a weekly basis. METHODS: Data concerning treatment of T2D with ExeOW are reviewed with special reference to its long-term efficacy, tolerability, and safety. Relevant literature was identified through the PubMed database from inception to January 2015...
July 3, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28672317/effect-of-insulin-degludec-vs-insulin-glargine-u100-on-hypoglycemia-in-patients-with-type-2-diabetes-the-switch-2-randomized-clinical-trial
#20
RANDOMIZED CONTROLLED TRIAL
Carol Wysham, Anuj Bhargava, Louis Chaykin, Raymond de la Rosa, Yehuda Handelsman, Lone N Troelsen, Kajsa Kvist, Paul Norwood
Importance: Hypoglycemia, a serious risk for insulin-treated patients with type 2 diabetes, negatively affects glycemic control. Objective: To test whether treatment with basal insulin degludec is associated with a lower rate of hypoglycemia compared with insulin glargine U100 in patients with type 2 diabetes. Design, Setting, and Participants: Randomized, double-blind, treat-to-target crossover trial including two 32-week treatment periods, each with a 16-week titration period and a 16-week maintenance period...
July 4, 2017: JAMA: the Journal of the American Medical Association
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