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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
#1
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...
October 13, 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
#2
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
#3
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. STUDY DESIGN AND 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)...
October 3, 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
#4
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...
September 23, 2016: 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
#5
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
https://www.readbyqxmd.com/read/27141654/-insulin-glargine-300-u-ml-toujeo%C3%A2
#6
A J Scheen
This article presents a new formulation of insulin glargine concentrated at 300 U/mL (Gla-300). It is commercialized under the trade name of Toujeo® in an optimized pre-filled SoloStar™ pen for the treatment of type 1 and type 2 diabetes in adults. Besides a threefold higher concentration compared to the classical insulin Lantus® (100 U/mL or Gla-100), both pharmacokinetic and pharmacodynamic profiles of Gla-300 are flatter and longer (more than 24 hours) and have a lesser intra-/inter-variability, which makes them more reproducible...
February 2016: Revue Médicale de Liège
https://www.readbyqxmd.com/read/27092018/advances-in-insulin-therapy-a-review-of-new-insulin-glargine-300-units-ml-in-the-management-of-diabetes
#7
John R White
In Brief New insulin glargine 300 units/mL (Gla-300) is a formulation of insulin glargine that has a more constant pharmacokinetic profile with a prolonged duration of action. The EDITION clinical trial program showed that the use of Gla-300 leads to glycemic control comparable to that of insulin glargine 100 units/mL in a wide range of populations of people with diabetes. It is associated with comparable to less nocturnal confirmed or severe hypoglycemia and less weight gain, despite requiring a somewhat higher insulin dose than U-100...
April 2016: Clinical Diabetes: a Publication of the American Diabetes Association
https://www.readbyqxmd.com/read/26990724/the-role-of-toujeo%C3%A2-insulin-glargine-u-300-in-the-treatment-of-diabetes-mellitus
#8
REVIEW
Meagan A Brown, Courtney S Davis, Laurie W Fleming, Joshua W Fleming
PURPOSE: The purpose of this article is to educate nurse practitioners about the role of Toujeo®, insulin glargine U-300 (Gla-300), which is a new option for the treatment of diabetes mellitus. DATA SOURCES: A comprehensive literature search was conducted using MEDLINE with the key terms: insulin glargine 300, Toujeo, Gla-300, and EDITION for clinical trial data. Other resources included package inserts, drug information websites, and the World Health Organization (WHO)...
September 2016: Journal of the American Association of Nurse Practitioners
https://www.readbyqxmd.com/read/26880669/safety-and-efficacy-of-insulin-glargine-300-u-ml-compared-with-other-basal-insulin-therapies-in-patients-with-type-2-diabetes-mellitus-a-network-meta-analysis
#9
Nick Freemantle, Engels Chou, Christian Frois, Daisy Zhuo, Walter Lehmacher, Aleksandra Vlajnic, Hongwei Wang, Hsing-Wen Chung, Quanwu Zhang, Eric Wu, Charles Gerrits
OBJECTIVE: To compare the efficacy and safety of a concentrated formulation of insulin glargine (Gla-300) with other basal insulin therapies in patients with type 2 diabetes mellitus (T2DM). DESIGN: This was a network meta-analysis (NMA) of randomised clinical trials of basal insulin therapy in T2DM identified via a systematic literature review of Cochrane library databases, MEDLINE and MEDLINE In-Process, EMBASE and PsycINFO. OUTCOME MEASURES: Changes in HbA1c (%) and body weight, and rates of nocturnal and documented symptomatic hypoglycaemia were assessed...
2016: BMJ Open
https://www.readbyqxmd.com/read/26840338/efficacy-and-safety-of-flexible-versus-fixed-dosing-intervals-of-insulin-glargine-300%C3%A2-u-ml-in-people-with-type-2-diabetes
#10
Matthew C Riddle, Geremia B Bolli, Philip D Home, Richard M Bergenstal, Monika Ziemen, Isabel Muehlen-Bartmer, Marek Wardecki, Laetitia Vinet, Nathalie Jeandidier, Hannele Yki-Järvinen
BACKGROUND: Insulin glargine 300 U/mL (Gla-300) has a more constant and prolonged action profile than insulin glargine 100 U/mL and in clinical studies is associated with similar glycemic control but less hypoglycemia. Whether its effects are altered by variability of injection time was examined in two 3-month substudies. MATERIALS AND METHODS: Eligible participants completing 6 months of optimized treatment with Gla-300 in EDITION 1 (n = 109) and EDITION 2 (n = 89), having a mean hemoglobin A1c (HbA1c) level of 7...
April 2016: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/26662964/new-insulin-glargine-300-u-ml-versus-glargine-100-u-ml-in-japanese-adults-with-type-1-diabetes-using-basal-and-mealtime-insulin-glucose-control-and-hypoglycaemia-in-a-randomized-controlled-trial-edition-jp-1
#11
M Matsuhisa, M Koyama, X Cheng, Y Takahashi, M C Riddle, G B Bolli, T Hirose
AIM: To compare efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of insulin glargine 100 U/ml (Gla-100) in Japanese adults with type 1 diabetes. METHODS: The EDITION JP 1 study (NCT01689129) was a 6-month, multicentre, open-label, phase III study. Participants (n = 243) were randomized to Gla-300 or Gla-100 while continuing mealtime insulin. Basal insulin was titrated with the aim of achieving a fasting self-monitored plasma glucose target of 4...
April 2016: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/26662838/new-insulin-glargine-300-u-ml-versus-glargine-100-u-ml-in-japanese-people-with-type-2-diabetes-using-basal-insulin-and-oral-antihyperglycaemic-drugs-glucose-control-and-hypoglycaemia-in-a-randomized-controlled-trial-edition-jp-2
#12
Y Terauchi, M Koyama, X Cheng, Y Takahashi, M C Riddle, G B Bolli, T Hirose
AIMS: To compare the efficacy and safety of insulin glargine 300 U/ml (Gla-300) with glargine 100 U/ml (Gla-100) in Japanese people with type 2 diabetes using basal insulin plus oral antihyperglycaemic drug(s) [OAD(s)]. METHODS: The EDITION JP 2 study (NCT01689142) was a 6-month, multicentre, open-label, phase III study. Participants (n = 241, male 61%, mean diabetes duration 14 years, mean weight 67 kg, mean body mass index 25 kg/m(2), mean glycated haemoglobin (HbA1c) 8...
April 2016: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/26311720/accuracy-and-injection-force-of-the-gla-300-injection-device-compared-with-other-commercialized-disposable-insulin-pens
#13
COMPARATIVE STUDY
David Klonoff, Irina Nayberg, Marissa Thonius, Florian See, Mona Abdel-Tawab, Frank Erbstein, Thomas Haak
BACKGROUND: To deliver insulin glargine 300 U/mL (Gla-300), the widely used SoloSTAR(®) pen has been modified to allow for accurate and precise delivery of required insulin units in one-third of the volume compared with insulin glargine 100 U/mL, while improving usability. Here we compare the accuracy and injection force of 3 disposable insulin pens: Gla-300 SoloSTAR(®), FlexPen(®), and KwikPen™. METHODS: For the accuracy assessment, 60 of each of the 3 tested devices were used for the delivery of 3 different doses (1 U, half-maximal dose, and maximal dose), which were measured gravimetrically...
August 26, 2015: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/26238470/new-insulin-glargine-300-u-ml-for-the-treatment-of-type-1-and-type-2-diabetes-mellitus
#14
REVIEW
Jennifer Goldman, John R White
OBJECTIVE: To describe the studies evaluating the efficacy and safety of new insulin glargine 300 U/mL (Gla-300) as a basal insulin in the treatment of type 1 (T1DM) and type 2 (T2DM) diabetes mellitus. DATA SOURCES: A literature search of MEDLINE was conducted (January 2008-June 2015) using the terms U300, Gla-300, and insulin glargine 300 units/mL and supplemented with congress abstracts published in 2014 and 2015. STUDY SELECTION AND DATA EXTRACTION: All English language studies assessing the efficacy and/or safety of Gla-300 were evaluated...
October 2015: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/26172084/glycaemic-control-and-hypoglycaemia-with-new-insulin-glargine-300-u-ml-versus-insulin-glargine-100-u-ml-in-people-with-type-2-diabetes-using-basal-insulin-and-oral-antihyperglycaemic-drugs-the-edition-2-randomized-12-month-trial-including-6-month-extension
#15
RANDOMIZED CONTROLLED TRIAL
H Yki-Järvinen, R M Bergenstal, G B Bolli, M Ziemen, M Wardecki, I Muehlen-Bartmer, M Maroccia, M C Riddle
AIMS: To compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) over 12 months of treatment in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs (OADs). METHODS: EDITION 2 (NCT01499095) was a randomized, 6-month, multicentre, open-label, two-arm, phase IIIa study investigating once-daily Gla-300 versus Gla-100, plus OADs (excluding sulphonylureas), with a 6-month safety extension...
December 2015: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/26139151/a-review-of-the-safety-and-efficacy-data-for-insulin-glargine-300%C3%A2-units-ml-a-new-formulation-of-insulin-glargine
#16
REVIEW
G Dailey, F Lavernia
Insulin glargine 100 units/ml (Gla-100) has become a standard of care in diabetes treatment over the past decade, providing 24-h basal insulin coverage after once-daily subcutaneous injection for many people with diabetes, with a well-established efficacy and safety profile. New insulin glargine 300 units/ml (Gla-300) is a basal insulin that provides the same number of units as Gla-100 in a third of the volume. Compared with Gla-100, Gla-300 has shown more constant and prolonged pharmacokinetic (PK)/pharmacodynamic (PD) profiles...
December 2015: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/26084341/new-insulin-glargine-300-units-ml-versus-glargine-100-units-ml-in-people-with-type-1-diabetes-a-randomized-phase-3a-open-label-clinical-trial-edition-4
#17
RANDOMIZED CONTROLLED TRIAL
Philip D Home, Richard M Bergenstal, Geremia B Bolli, Monika Ziemen, Maria Rojeski, Melanie Espinasse, Matthew C Riddle
OBJECTIVE: Insulin therapy in type 1 diabetes still provides suboptimal outcomes. Insulin glargine 300 units/mL (Gla-300), with a flatter pharmacodynamic profile compared with insulin glargine 100 units/mL (Gla-100), is an approach to this problem. RESEARCH DESIGN AND METHODS: People with type 1 diabetes, using a mealtime and basal insulin regimen, were randomized open-label to Gla-300 or Gla-100 and to morning or evening injection, continuing the mealtime analog, and followed for 6 months...
December 2015: Diabetes Care
https://www.readbyqxmd.com/read/26055218/continuous-glucose-monitoring-during-basal-bolus-therapy-using-insulin-glargine-300%C3%A2-u%C3%A2-ml-1-and-glargine-100%C3%A2-u%C3%A2-ml-1-in-japanese-people-with-type-1-diabetes-mellitus-a-crossover-pilot-study
#18
Hideaki Jinnouchi, Masayoshi Koyama, Atsushi Amano, Yoshinori Takahashi, Akira Yoshida, Kunio Hieshima, Seigo Sugiyama, Noboru Kurinami, Tomio Jinnouchi, Reinhard Becker
INTRODUCTION: New insulin glargine 300 U mL(-1) (Gla-300) is a basal insulin that shows more stable and prolonged pharmacokinetic and pharmacodynamic profiles than insulin glargine 100 U mL(-1) (Gla-100). This study used continuous glucose monitoring (CGM) to compare 24-h glucose profiles in a Japanese population using Gla-300 versus Gla-100. METHODS: This was an exploratory 8.4-week, single-center, 2-sequence, 2-period, open-label crossover study. Japanese adults with type 1 diabetes mellitus (T1DM) treated with basal-bolus insulin, with glycated hemoglobin (HbA1c) 6...
June 2015: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/25929311/patient-level-meta-analysis-of-the-edition-1-2-and-3-studies-glycaemic-control-and-hypoglycaemia-with-new-insulin-glargine-300-u-ml-versus-glargine-100-u-ml-in-people-with-type-2-diabetes
#19
R Ritzel, R Roussel, G B Bolli, L Vinet, C Brulle-Wohlhueter, S Glezer, H Yki-Järvinen
AIMS: To conduct a patient-level meta-analysis of the EDITION 1, 2 and 3 studies, which compared the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) in people with type 2 diabetes (T2DM) on basal and mealtime insulin, basal insulin and oral antihyperglycaemic drugs, or no prior insulin, respectively. METHODS: The EDITION studies were multicentre, randomized, open-label, parallel-group, phase IIIa studies, with similar designs and endpoints...
September 2015: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/25846721/one-year-sustained-glycaemic-control-and-less-hypoglycaemia-with-new-insulin-glargine-300-u-ml-compared-with-100-u-ml-in-people-with-type-2-diabetes-using-basal-plus-meal-time-insulin-the-edition-1-12-month-randomized-trial-including-6-month-extension
#20
RANDOMIZED CONTROLLED TRIAL
M C Riddle, H Yki-Järvinen, G B Bolli, M Ziemen, I Muehlen-Bartmer, S Cissokho, P D Home
AIMS: To evaluate the maintenance of efficacy and safety of insulin glargine 300 U/ml (Gla-300) versus glargine 100 U/ml (Gla-100) in people with type 2 diabetes mellitus (T2DM) using basal plus meal-time insulin for 12 months in the EDITION 1 trial. METHODS: EDITION 1 was a multicentre, randomized, open-label, two-arm, phase IIIa study. Participants completing the initial 6-month treatment period continued to receive Gla-300 or Gla-100, as previously randomized, once daily for a further 6-month open-label extension phase...
September 2015: Diabetes, Obesity & Metabolism
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