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Gla-300

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https://www.readbyqxmd.com/read/29153485/morning-administration-of-0-4u-kg-day-insulin-glargine-300u-ml-provides-less-fluctuating-24-hour-pharmacodynamics-and-more-even-pharmacokinetic-profiles-compared-with-insulin-degludec-100u-ml-in-type-1-diabetes
#1
T S Bailey, J Pettus, R Roussel, W Schmider, M Maroccia, N Nassr, O Klein, G B Bolli, R Dahmen
AIM: To compare steady state pharmacodynamic and pharmacokinetic profiles of insulin glargine 300U/mL (Gla-300) with insulin degludec 100U/mL (Deg-100) in people with type 1 diabetes. METHODS: This single-centre, randomized, double-blind crossover euglycaemic clamp study included two parallel cohorts with fixed once-daily morning dose regimens. For both insulins participants received 0.4 (n=24) or 0.6U/kg/day (n=24), before breakfast, for 8 days prior to the clamp...
November 16, 2017: Diabetes & Metabolism
https://www.readbyqxmd.com/read/29106816/insulin-glargine-300-u-ml-is-associated-with-less-weight-gain-while-maintaining-glycemic-control-and-low-risk-of-hypoglycemia-compared-with-insulin-glargine-100-u-ml-in-an-aging-population-with-type-2-diabetes
#2
Medha N Munshi, Jasvinder Gill, Jason Chao, Elena V Nikonova, Meenakshi Patel
OBJECTIVE: Assess efficacy, hypoglycemia and weight gain in patients with type 2 diabetes (T2D) treated with insulin glargine 300 U/mL (Gla-300) or 100 U/mL (Gla-100) across different age groups. METHODS: Pooled data were generated for patients randomized to Gla-300 or Gla-100 in the EDITION 2 (NCT01499095) and 3 (NCT01676220) studies. In four age groups (<55, ≥55 to <60, ≥60 to <65, ≥65 years), glycated hemoglobin A1C (A1C), percentage of patients reaching A1C <7...
November 6, 2017: Endocrine Practice
https://www.readbyqxmd.com/read/28862801/better-glycaemic-control-and-less-hypoglycaemia-with-insulin-glargine-300-u-ml-versus-glargine-100-u-ml-one-year-patient-level-meta-analysis-of-the-edition-clinical-studies-in-people-with-type-2-diabetes
#3
Robert Ritzel, Ronan Roussel, Andrea Giaccari, Jiten Vora, Claire Brulle-Wohlhueter, Hannele Yki-Järvinen
AIMS: To investigate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) over 12 months in a patient-level meta-analysis using data from EDITION studies in people with type 2 diabetes (T2DM). METHODS: EDITION 1, 2 and 3 were multicentre, randomised, open-label, two-arm, parallel-group, treat-to-target phase 3a studies. Similar study designs and endpoints enabled a meta-analysis to be conducted. RESULTS: Reductions in HbA1c were better sustained over 12 months with Gla-300 than Gla-100 (least squares [LS] mean difference in change from baseline: -0...
September 1, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28828553/-which-patients-from-routine-care-use-the-new-insulin-analogue-glargine-u300-compared-to-patients-with-glargine-u100-a-multicenter-analysis-of-14-123-patients-with-insulin-glargine-from-die-diabetes-registries-dpv-and-dive
#4
Barbara Bohn, Peter Bramlage, Christian Wagner, Matthias Kaltheuner, Reinhard Welp, Stefan Sziegoleit, Artur Zimmermann, Hans Martin Reuter, Michael Hummel, Jörg Gloyer, Reinhard W Holl, Thomas Danne
BACKGROUND: Glargine U300 (Gla-300) is a further development of glargine U100 (Gla-100). Since 2015, Gla-300 has been available in Germany and Austria. We compared patients initiating therapy with Gla-300 with patients starting with Gla-100. Moreover, it was investigated whether patients from real-life diabetes care differ from patients participating in the EDITION clinical study program. METHODS: Data are based on the diabetes registries DPV and DIVE. Patients started/switched to Gla-100 or Gla-300 in 2015 were included...
August 21, 2017: Wiener Medizinische Wochenschrift
https://www.readbyqxmd.com/read/28803820/titration-a-randomized-study-to-assess-2-treatment-algorithms-with-new-insulin-glargine-300-units-ml
#5
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...
October 2017: Canadian Journal of Diabetes
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
#6
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/28721081/insulin-glargine-300-u-ml-for-basal-insulin-therapy-in-type-1-and-type-2-diabetes-mellitus
#7
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/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
#8
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/28622950/glycaemic-control-and-hypoglycaemia-with-insulin-glargine-300u-ml-versus-insulin-glargine-100u-ml-in-insulin-na%C3%A3-ve-people-with-type-2%C3%A2-diabetes-12-month-results-from-the-edition-3-trial
#9
G B Bolli, M C Riddle, R M Bergenstal, M Wardecki, H Goyeau, P D Home
AIM: To explore if efficacy and safety findings for insulin glargine 300U/mL (Gla-300) versus insulin glargine 100U/mL (Gla-100), observed over 6 months in insulin-naïve people with type 2 diabetes, are maintained after 12 months. METHODS: EDITION 3 was a phase 3a, randomized, multicentre, open-label, parallel-group, treat-to-target study of once-daily Gla-300 versus Gla-100 (target fasting self-monitored plasma glucose, 4.4-5.6mmol/L [80-100mg/dL]). Participants completing the initial 6-month treatment phase continued their previously allocated basal insulin...
September 2017: Diabetes & Metabolism
https://www.readbyqxmd.com/read/28467113/efficacy-and-safety-of-insulin-glargine-300-u-ml-versus-insulin-glargine-100-u-ml-in-high-risk-and-low-risk-patients-with-type-2-diabetes-stratified-using-common-clinical-performance-measures
#10
Ildiko Lingvay, Jason Chao, Mehul R Dalal, Luigi F Meneghini
BACKGROUND: To determine whether previously reported reductions in hypoglycemia associated with insulin glargine 300 U/mL (Gla-300) compared with insulin glargine 100 U/mL (Gla-100) are impacted by patient risk category in type 2 diabetes (T2D), clinical performance measures based on the Healthcare Effectiveness Data and Information Set (HEDIS) were applied to patient-level data from the EDITION 2 and EDITION 3 clinical trials that compared Gla-300 and Gla-100. METHODS: In this post hoc analysis, patients were stratified as low risk (LR) if patients were <65 years old with no comorbidities derived from HEDIS (HbA1c target <7...
May 2017: Diabetes Technology & Therapeutics
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
#11
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/28187863/a-review-of-the-clinical-efficacy-and-safety-of-insulin-degludec-and-glargine-300-u-ml-in-the-treatment-of-diabetes-mellitus
#12
REVIEW
Vincent C Woo
PURPOSE: The treatment of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) using insulin is not ideal at this time. Despite advances made with basal insulin analogues, many individuals achieve less than optimal glycemic control or are at risk for hypoglycemia. Currently available basal insulin analogues do not deliver steady, peakless, continuous insulin for >24 hours and are associated with adverse events, including hypoglycemia. The objective of this paper was to review the clinical efficacy and safety of upcoming long-acting insulin analogues such as insulin degludec and insulin glargine 300 U/mL (Gla-300)...
February 7, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28132529/insulin-glargine-300-units-ml-a-guide-for-healthcare-professionals-involved-in-the-management-of-diabetes
#13
REVIEW
Jodi Strong, Davida Kruger, Lucia Novak
Insulin glargine 300 units/mL: Insulin glargine 300 units/mL (Gla-300) is a formulation of insulin glargine that delivers the same number of insulin units in one-third of the injectable volume of insulin glargine 100 units/mL (Gla-100). Glucose control: Recently approved in the United States and in Europe for use in type 1 and type 2 diabetes, Gla-300 has a more constant and evenly distributed glucose-lowering effect compared with Gla-100, with a duration of action beyond 24 hours and lower within-day and between-day intra-individual variability in blood glucose levels...
April 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28115474/comparison-of-insulin-glargine-300-units-ml-and-100-units-ml-in-adults-with-type-1-diabetes-continuous-glucose-monitoring-profiles-and-variability-using-morning-or-evening-injections
#14
RANDOMIZED CONTROLLED TRIAL
Richard M Bergenstal, Timothy S Bailey, David Rodbard, Monika Ziemen, Hailing Guo, Isabel Muehlen-Bartmer, Andrew J Ahmann
OBJECTIVE: The objective of this study was to compare glucose control in participants with type 1 diabetes receiving insulin glargine 300 units/mL (Gla-300) or glargine 100 units/mL (Gla-100) in the morning or evening, in combination with mealtime insulin. RESEARCH DESIGN AND METHODS: In this 16-week, exploratory, open-label, parallel-group, two-period crossover study (clinicaltrials.gov identifier NCT01658579), 59 adults with type 1 diabetes were randomized (1:1:1:1) to once-daily Gla-300 or Gla-100 given in the morning or evening (with crossover in the injection schedule)...
April 2017: Diabetes Care
https://www.readbyqxmd.com/read/27972203/cost-utility-evaluation-of-insulin-glargine-300-gla-300-versus-insulin-glargine-100-gla-100-in-patients-with-type-2-diabetes-mellitus-t2dm
#15
M Delgado, M Rubio, D Gasche, M Fournier, S Monereo
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27835765/sustained-glycaemic-control-and-less-nocturnal-hypoglycaemia-with-insulin-glargine-300u-ml-compared-with-glargine-100u-ml-in-japanese-adults-with-type-1-diabetes-edition-jp-1-randomised-12-month-trial-including-6-month-extension
#16
RANDOMIZED CONTROLLED TRIAL
Munehide Matsuhisa, Masayoshi Koyama, Xi Cheng, Mariko Sumi, Matthew C Riddle, Geremia B Bolli, Takahisa Hirose
AIMS: To evaluate the efficacy and safety of insulin glargine 300U/mL (Gla-300) versus glargine 100U/mL (Gla-100) in adults with type 1 diabetes in Japan over 12months. METHODS: EDITION JP 1 was a multicentre, randomised, open-label phase 3 study. Following a 6-month on-treatment period, participants continued to receive Gla-300 or Gla-100 once daily, plus mealtime insulin, over a 6-month open-label extension phase. HbA1c, hypoglycaemia, body weight and adverse events were assessed...
December 2016: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/27710135/pharmacodynamic-and-pharmacokinetic-evaluation-of-insulin-glargine-u300-for-the-treatment-of-type-1-diabetes
#17
REVIEW
Kathryn M Hurren, Jessica L O'Neill
Glargine 300 units/ml (Gla-300) is a novel basal insulin formulation approved in 2015 for the treatment of diabetes. This more concentrated form of glargine causes delayed redissolution from the subcutaneous depot after injection and thus altered action profile. Areas covered: The pharmacokinetics, pharmacodynamics, efficacy, and safety of Gla-300 in patients with type 1 diabetes mellitus (T1DM) will be reviewed. Expert opinion: Gla-300 has a flatter and more prolonged pharmacokinetic profile compared to glargine 100 units/ml (Gla-100), but is less potent on a unit per unit basis...
December 2016: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/27690710/achieve-control-a-pragmatic-clinical-trial-of-insulin-glargine-300-u-ml-versus-other-basal-insulins-in-insulin-na%C3%A3-ve-patients-with-type-2-diabetes
#18
RANDOMIZED CONTROLLED TRIAL
Gerry Oster, Sean D Sullivan, Mehul R Dalal, Mahmood R Kazemi, Maria Rojeski, Carol H Wysham, Jennifer Sung, Bryan Johnstone, Anna M G Cali, L J Wei, Louise Traylor, Henry Anhalt, Michelle Hull, John Van Vleet, Luigi F Meneghini
OBJECTIVE: This study aims to compare the effectiveness of insulin glargine 300 U/mL (Gla-300) with its accompanying patient support program with that of other basal insulin and available patient support programs in patients with type 2 diabetes (T2D) in a real-world setting in terms of achieving HEDIS (Healthcare Effectiveness Data and Information Set) individualized glycemic targets without documented symptomatic hypoglycemia. METHODS: Achieve Control is a US-based, multicenter, randomized, open-label, active-controlled, parallel group pragmatic Phase IV trial in insulin-naïve patients with T2D uncontrolled on ≥2 oral antidiabetes drugs (OAD) and/or glucagon-like peptide-1 receptor antagonists (GLP-1 RA)...
November 2016: Postgraduate Medicine
https://www.readbyqxmd.com/read/27664062/ease-of-use-of-the-insulin-glargine-300-u-ml-pen-injector-in-insulin-na%C3%A3-ve-people-with-type-2-diabetes
#19
Harald Pohlmeier, Lori Berard, Claire Brulle-Wohlhueter, Junlong Wu, Raphael Dahmen, Irene Nowotny, David Klonoff
BACKGROUND: Insulin glargine 300 U/mL (Gla-300) contains the same active ingredient as glargine 100 U/mL (Gla-100), and provides the same number of units in one-third of the volume. The SoloSTAR(®) injector pen has been modified to ensure accurate administration of this reduced volume and to improve user experience. METHODS: Insulin- and pen-naïve adults with type 2 diabetes (T2DM) inadequately controlled with oral antihyperglycemic drugs, who had glycated hemoglobin (HbA1c) levels of 7...
March 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/27453980/pharmacokinetics-and-pharmacodynamics-of-insulin-glargine-300-u-ml-in-the-treatment-of-diabetes-and-their-clinical-relevance
#20
REVIEW
David R Owens
INTRODUCTION: A more concentrated insulin glargine formulation, containing 300 U/mL (Gla-300) was approved in 2015 in the US and Europe for the treatment of diabetes mellitus in adults. AREAS COVERED: This drug evaluation focuses on the pharmacokinetics (PK) and pharmacodynamics (PD) of Gla-300 from studies published up to May 2016. The clinical relevance of this new formulation will be addressed. EXPERT OPINION: Gla-300 was developed to produce a flatter and more prolonged PK/PD profile compared with insulin glargine 100 U/mL (Gla-100) in order to maintain effective glycemic control and reduce the risk of hypoglycemia...
August 2016: Expert Opinion on Drug Metabolism & Toxicology
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