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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
#1
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
#2
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
#3
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
#4
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...
July 18, 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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/28672316/effect-of-insulin-degludec-vs-insulin-glargine-u100-on-hypoglycemia-in-patients-with-type-1-diabetes-the-switch-1-randomized-clinical-trial
#12
RANDOMIZED CONTROLLED TRIAL
Wendy Lane, Timothy S Bailey, Gregg Gerety, Janusz Gumprecht, Athena Philis-Tsimikas, Charlotte Thim Hansen, Thor S S Nielsen, Mark Warren
Importance: Hypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death. Objective: To determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes. Design, Setting, and Participants: Double-blind, randomized, crossover noninferiority trial involving 501 adults with at least 1 hypoglycemia risk factor treated at 84 US and 6 Polish centers (January 2014-January 12, 2016) for two 32-week treatment periods, each with a 16-week titration and a 16-week maintenance period...
July 4, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28671753/glycaemic-outcomes-of-an-individualised-treatment-approach-for-older-vulnerable-patients-a-randomised-controlled-study-in-type-2-diabetes-mellitus-imperium
#13
Simon R Heller, Richard E Pratley, Alan Sinclair, Andreas Festa, Jacek Kiljanski, Cynthia S Brusko, Ran Duan, Robert J Heine
AIM: To compare the glycaemic outcomes of 2 glucose-lowering treatment strategies in vulnerable (moderately ill and/or frail) patients aged ≥65 years with type 2 diabetes whose individual HbA1c targets were not met with diet/exercise and/or oral antihyperglycaemic medications (OAMs). METHODS: The primary endpoint of this study was a composite of achieving/maintaining individualised HbA1c targets without 'clinically significant' hypoglycaemia (severe hypoglycaemia or repeated hypoglycaemia causing interruption of patients' activities or blood glucose <54 mg/dL)...
July 3, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28669463/three-year-efficacy-and-safety-of-exenatide-once-weekly-a-pooled-analysis-of-three-trials
#14
Michael E Trautmann, Luc Van Gaal, Jenny Han, Elise Hardy
AIMS: To evaluate the 3-year efficacy and safety of exenatide once weekly (QW) for type 2 diabetes (T2D) in a large clinical population. METHODS: This post hoc analysis of three DURATION studies examined pooled efficacy and adverse events with exenatide QW from the 2.5- to 3-year completer populations; insulin glargine (glargine) was a reference (DURATION-3). Patients randomized to exenatide QW during the controlled study periods continued controlled treatment (DURATION-3) or single-arm treatment (DURATION-1; DURATION-2) with exenatide QW for the study duration...
June 20, 2017: Journal of Diabetes and its Complications
https://www.readbyqxmd.com/read/28667587/insulin-glargine-lixisenatide-a-review-in-type-2-diabetes
#15
Lesley J Scott
Subcutaneous insulin glargine/lixisenatide (Suliqua™) is a titratable, fixed-ratio combination of a long-acting basal insulin analogue and a glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of adult patients with inadequately controlled type 2 diabetes. Once-daily insulin glargine/lixisenatide, in combination with metformin, provided effective glycaemic control and was generally well tolerated in the 30-week, multinational, phase 3 LixiLan-O and LixiLan-L trials in insulin-naive and -experienced adult patients with inadequately controlled type 2 diabetes...
June 30, 2017: Drugs
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
#16
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/28661585/glycaemic-control-and-hypoglycaemia-during-12-months-of-randomized-treatment-with-insulin-glargine-300-u-ml-versus-glargine-100-u-ml-in-people-with-type-1-diabetes-edition-4
#17
Philip D Home, Richard M Bergenstal, Geremia B Bolli, Monika Ziemen, Maria Rojeski, Melanie Espinasse, Matthew C Riddle
AIMS: Insulin glargine 300 U/mL (Gla-300) offers a flatter pharmacodynamic profile than insulin glargine 100 U/mL (Gla-100). We have compared these insulins over 1 year in people with type 1 diabetes (T1DM). METHODS: EDITION 4 was a 6-month, multicentre, randomized, open-label phase 3 study. People with T1DM completing the 6 months continued their randomized Gla-300 or Gla-100 once daily, morning or evening, for a further 6 months. RESULTS: Of 549 participants randomized, 444 completed the 12-month study period (Gla-300, 80%; Gla-100, 82%)...
June 29, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28652565/ketoacidosis-in-neonatal-diabetes-mellitus-part-of-wolcott-rallison-syndrome
#18
Poorna Gopal Azad Sreeramaneni, Subba Rao V Ambula
BACKGROUND Neonatal diabetes mellitus is a rare condition and it is important to differentiate it from other causes, such as hyperglycemia in infancy, for better outcomes. We report a case of an infant who presented to our neonatal intensive care unit in ketoacidosis and a comatose state. CASE REPORT Our case was an infant who presented to the neonatal intensive care unit at 38 days of age in ketoacidosis. The female infant, born to consanguineous parents (first cousins), weighing 2,300 grams at birth, presented with extreme dehydration and pale skin...
June 27, 2017: American Journal of Case Reports
https://www.readbyqxmd.com/read/28651211/effect-of-insulin-degludec-versus-insulin-glargine-on-glycemic-control-and-daily-fasting-blood-glucose-variability-in-insulin-na%C3%A3-ve-japanese-patients-with-type-2-diabetes-i-d-got-trial
#19
Yoshimasa Aso, Kunihiro Suzuki, Yasuko Chiba, Minoru Sato, Nobuya Fujita, Yoshihisa Takada, Shunichi Murano, Hisamoto Kuroda
AIMS: Insulin degludec (IDeg) is an ultra-long-acting insulin that has a smooth time/action profile over more than 42h. The present study compared the effects of IDeg and insulin glargine (IGlar) on HbA1c reduction and on within-subject day-to-day variability of fasting blood glucose (FBG) in insulin-naïve patients with type 2 diabetes. SUBJECTS AND METHODS: Eligible patients were randomly allocated at a 3:1 ratio to receive once-daily IDeg (n=31) or IGlar (n=12)...
June 15, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/28649943/cost-effectiveness-of-insulin-detemir-versus-insulin-glargine-for-thai-type-2-diabetes-from-a-payer-s-perspective
#20
Unchalee Permsuwan, Kednapa Thavorn, Piyameth Dilokthornsakul, Surasak Saokaew, Nathorn Chaiyakunapruk
AIMS: An economic evidence is a vital tool that can inform the decision to use costly insulin analogs. This study aimed to evaluate long-term cost-effectiveness of insulin detemir (IDet) compared with insulin glargine (IGlar) in type 2 diabetes (T2DM) from the Thai payer's perspective. METHODS: Long-term costs and outcomes were projected using a validated IMS CORE Diabetes Model, version 8.5. Cohort characteristics, baseline risk factors, and costs of diabetes complications were derived from Thai data sources...
July 11, 2017: Journal of Medical Economics
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