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https://www.readbyqxmd.com/read/29895556/a-randomized-controlled-trial-comparing-efficacy-and-safety-of-insulin-glargine-300-units-ml-versus-100-units-ml-in-older-people-with-type-2-diabetes-results-from-the-senior-study
#1
Robert Ritzel, Stewart B Harris, Helen Baron, Hermes Florez, Ronan Roussel, Melanie Espinasse, Isabel Muehlen-Bartmer, Nianxian Zhang, Monica Bertolini, Claire Brulle-Wohlhueter, Medha Munshi, Geremia B Bolli
OBJECTIVE: SENIOR compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in older people (≥65 years old) with type 2 diabetes. RESEARCH DESIGN AND METHODS: SENIOR was an open-label, two-arm, parallel-group, multicenter phase 3b trial designed to enroll ∼20% of participants aged ≥75 years. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to a fasting self-monitored plasma glucose of 5...
June 12, 2018: Diabetes Care
https://www.readbyqxmd.com/read/29888454/glycaemic-control-hypoglycaemia-and-weight-change-with-insulin-glargine-300-u-ml-versus-insulin-glargine-100-u-ml-in-japanese-adults-with-type-2-diabetes-a-12-month-comparison-by-concomitant-sulphonylurea-and-or-glinide-use
#2
Yasuo Terauchi, Matthew C Riddle, Takahisa Hirose, Masayoshi Koyama, Xi Cheng, Yoshinori Takahashi, Geremia B Bolli
AIM: To explore if clinical effects and hypoglycaemia risks associated with insulin glargine 300 U/mL (Gla-300) and 100 U/mL (Gla-100) differed by sulphonylurea and/or glinide (SU/G) treatment. METHODS: This was a post hoc subgroup analysis of 12-month treatment data from EDITION JP 2 (randomised, open-label, phase 3 study of Japanese people with type 2 diabetes [T2DM] receiving once-daily Gla-300/Gla-100+oral antihyperglycaemic drugs). Participants previously receiving SU/G (+SU/G) were compared with those not taking SU/G (-SU/G)...
June 11, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29760318/efficacy-and-safety-of-switching-from-insulin-glargine-100-u-ml-to-the-same-dose-of-glargine-300-u-ml-in-japanese-type-1-and-2-diabetes-patients-a-retrospective-analysis
#3
Shuhei Nakanishi, Masahiro Iwamoto, Shinji Kamei, Hidenori Hirukawa, Masashi Shimoda, Fuminori Tatsumi, Kenji Kohara, Atsushi Obata, Tomohiko Kimura, Tomoe Kinoshita, Shintaro Irie, Junpei Sanada, Yoshiro Fushimi, Momoyo Nishioka, Akiko Mizoguchi, Miyuki Kameyama, Tomoatsu Mune, Kohei Kaku, Hideaki Kaneto
Objective Insulin glargine [300 U/mL (Gla-300)] achieved better glycemic control and reduced the risk of hypoglycemia in comparison to glargine [100 U/mL; (Gla-100)] in phase 3 trials. This is the first study to retrospectively evaluate the efficacy and safety of Gla-300 in Japanese type 1 and 2 diabetes patients in a routine clinical setting. Methods We analyzed 20 type 1 diabetes patients and 62 type 2 diabetes patients who switched from Gla-100 to the same dose of Gla-300. Sixty type 2 diabetes patients who continued the use of Gla-100 during the study were included as controls...
2018: Internal Medicine
https://www.readbyqxmd.com/read/29649539/switching-to-insulin-glargine-300-u-ml-is-duration-of-prior-basal-insulin-therapy-important
#4
Riccardo C Bonadonna, Eric Renard, Alice Cheng, Andreas Fritsche, Anna Cali, Lydie Melas-Melt, Guillermo E Umpierrez
AIMS: To assess the impact of duration of prior basal insulin therapy on study outcomes in people with type 2 diabetes mellitus receiving insulin glargine 300 U/mL (Gla-300) or insulin glargine 100 U/mL (Gla-100) for 6 months. METHODS: A post hoc patient-level meta-analysis of data from the EDITION 1 and 2 studies. Outcomes included: HbA1c , percentage of participants with ≥1 confirmed or severe hypoglycaemic event at night (00:00-05:59 h) or any time (24 h), and body weight change...
April 9, 2018: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/29619751/basal-bolus-insulin-therapy-with-gla-300-during-hospitalization-reduces-nocturnal-hypoglycemia-in-patients-with-type-2-diabetes-mellitus-a-randomized-controlled-study
#5
Fumitaka Okajima, Yuko Nakamura, Yuji Yamaguchi, Yuki Shuto, Katsuhito Kato, Hitoshi Sugihara, Naoya Emoto
INTRODUCTION: Although reduction in the incidence of nocturnal hypoglycemia, as estimated by symptom or self-monitored plasma glucose, was shown to be more pronounced with 300 units/mL insulin glargine (Gla-300) than with 100 units/mL insulin glargine (Gla-100) in type 2 diabetes patients, the exact frequency of nocturnal hypoglycemia estimated with continuous glucose monitoring (CGM) has not been reported. METHODS: Forty patients with type 2 diabetes who were admitted for glycemic control with basal-bolus insulin therapy (BBT) were randomized into the Gla-100 and Gla-300 groups...
June 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29619208/conversion-from-insulin-glargine-u-100-to-insulin-glargine-u-300-or-insulin-degludec-and-the-impact-on-dosage-requirements
#6
Scott M Pearson, Jennifer M Trujillo
Background: We wanted to determine whether basal insulin requirements change when patients transition from insulin glargine U-100 (Gla-100) to insulin glargine U-300 (Gla-300) or insulin degludec. Methods: This study involved subjects seen in the University of Colorado Health Endocrine Clinic who were transitioned from Gla-100 to either Gla-300 ( n = 95) or insulin degludec ( n = 39). The primary outcome was the difference between baseline Gla-100 dose and dose of Gla-300 or insulin degludec prescribed after first follow-up visit within 1-12 months...
April 2018: Therapeutic Advances in Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29548798/clinical-perspectives-from-the-begin-and-edition-programmes-trial-level-meta-analyses-outcomes-with-either-degludec-or-glargine-300u-ml-vs-glargine-100u-ml-in-t2dm
#7
R Roussel, R Ritzel, E Boëlle-Le Corfec, B Balkau, J Rosenstock
AIMS: To explore comparative glycaemic control and hypoglycaemia incidence with insulin degludec 100U/mL (IDeg) or insulin glargine 300U/mL (Gla-300) versus glargine 100U/mL (Gla-100) in trial-level meta-analyses of phase 3a clinical trials including people with type-2 diabetes. METHODS: Meta-analyses of HbA1c , fasting plasma glucose (FPG), average 24h self-measured plasma glucose (SMPG), pre-breakfast SMPG and hypoglycaemia incidence and rate, using data from the BEGIN (IDeg) and EDITION (Gla-300) insulin development programmes, were performed...
February 19, 2018: Diabetes & Metabolism
https://www.readbyqxmd.com/read/29547043/hypoglycemia-in-the-elderly-with-diabetes-a-growing-problem-with-emerging-solutions
#8
Martin M Grajower
Hypoglycemia is the major side effect of insulin therapy. The elderly are especially vulnerable to episodes of hypoglycemia, and with greater risks of complications such as falls. Two new long-acting basal insulins, glargine-300 (Gla-300) and degludec, are associated with lower incidences of hypoglycemia than previously available basal insulins. One of them, Gla-300, was studied in the elderly and has a lower incidence of hypoglycemia in patients over 65 years old. These new data should be incorporated into decision making when treating the elderly patient with insulin, whether they have type 1 or 2 diabetes...
March 2018: Endocrine Practice
https://www.readbyqxmd.com/read/29370218/the-effect-of-concomitant-dppivi-use-on-glycaemic-control-and-hypoglycaemia-with-insulin-glargine-300-u-ml-gla-300-versus-insulin-glargine-100-u-ml-gla-100-in-people-with-type-2-diabetes-a-patient-level-meta-analysis-of-edition-2-and-3
#9
Jean-François Yale, Jeremy Hodson Pettus, Miguel Brito-Sanfiel, Fernando Lavalle-Gonzalez, Ana Merino-Trigo, Peter Stella, Soazig Chevalier, Raffaella Buzzetti
AIMS: To evaluate the effect of concomitant dipeptidyl peptidase IV inhibitor (DPPIVi) use on efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in people with type 2 diabetes on oral antihyperglycaemic drugs. METHODS: A post hoc patient-level meta-analysis was performed using data from EDITION 2 (basal insulin [N = 811]) and EDITION 3 (insulin-naïve [N = 878]), multicentre, randomised, open-label, parallel-group, phase 3a trials of similar design...
2018: PloS One
https://www.readbyqxmd.com/read/29313285/treatment-dosing-patterns-and-clinical-outcomes-for-patients-with-type-2-diabetes-starting-or-switching-to-treatment-with-insulin-glargine-300-units-per-milliliter-in-a-real-world-setting-a-retrospective-observational-study
#10
Shaloo Gupta, Hongwei Wang, Neil Skolnik, Liyue Tong, Ryan M Liebert, Lulu K Lee, Peter Stella, Anna Cali, Ronald Preblick
INTRODUCTION: Usage patterns and effectiveness of a longer-acting formulation of insulin glargine at a strength of 300 units per milliliter (Gla-300) have not been studied in real-world clinical practice. This study evaluated differences in dosing and clinical outcomes before and after Gla-300 treatment initiation in patients with type 2 diabetes starting or switching to treatment with Gla-300 to assess whether the benefits observed in clinical trials translate into real-world settings...
January 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29277378/assessment-of-hypoglycaemia-during-basal-insulin-therapy-temporal-distribution-and-risk-of-events-using-a-predefined-or-an-expanded-definition-of-nocturnal-events
#11
M C Riddle, G B Bolli, A Avogaro, M Gimenez Álvarez, A Merino-Trigo, E Boëlle-Le Corfec, P D Home
AIM: To describe in type 2 diabetes the 24-hour distribution of hypoglycaemia and compare the frequency of nocturnal events based on a predefined nocturnal window or an expanded interval, using illustrative data for two insulin glargine formulations. METHODS: Temporal distribution of hypoglycaemic events was assessed descriptively and by profile using participant-level data from three randomized trials comparing insulin glargine 300 U/mL (Gla-300) and 100 U/mL (Gla-100)...
December 11, 2017: Diabetes & Metabolism
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
#12
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...
February 2018: 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
#13
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 4 age groups (<55, ≥55 to <60, ≥60 to <65, ≥65 years), glycated hemoglobin A1C (A1C), percentage of patients reaching A1C <7...
February 2018: Endocrine Practice
https://www.readbyqxmd.com/read/28862801/better-glycaemic-control-and-less-hypoglycaemia-with-insulin-glargine-300-u-ml-vs-glargine-100-u-ml-1-year-patient-level-meta-analysis-of-the-edition-clinical-studies-in-people-with-type-2-diabetes
#14
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) vs insulin glargine 100 U/mL (Gla-100) over 12 months in a patient-level meta-analysis, using data from the EDITION studies in people with type 2 diabetes (T2DM). METHODS: EDITION 1, 2 and 3 were multicentre, randomized, open-label, 2-arm, parallel-group, treat-to-target phase IIIa studies. Similar study designs and endpoints enabled a meta-analysis to be conducted. RESULTS: Reductions in glycated haemoglobin (HbA1c) were better sustained over 12 months with Gla-300 than with Gla-100 (least squares [LS] mean difference in change from baseline: -0...
March 2018: 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
#15
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
#16
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
#17
Ronan Roussel, Michael C d'Emden, Miles Fisher, F Javier Ampudia-Blasco, Peter Stella, Florence Bizet, Anna M G Cali, Carol H Wysham
In this post hoc analysis we compared glycaemic control and hypoglycaemia between insulin glargine 300 U/mL (Gla-300) and glargine 100 U/mL (Gla-100) administered once daily in people with type 2 diabetes (T2DM) from the EDITION 1 (basal plus mealtime insulin) and EDITION 2 (basal insulin plus oral antihyperglycaemic drugs) trials who were previously receiving twice-daily insulin. At randomization, 16.9% and 20.0% of people in EDITION 1 and 2, respectively, were receiving twice-daily basal insulin. Glycated haemoglobin change from baseline to Month 6 was similar over 6 months with Gla-300 or Gla-100 (least squares mean difference -0...
February 2018: 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
#18
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
#19
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 who completed the 6 months continued randomized Gla-300 or Gla-100 once daily, morning or evening, for a further 6 months. RESULTS: Among 549 participants randomized, 444 completed the 12-month study period (Gla-300, 80%; Gla-100, 82%)...
January 2018: 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
#20
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
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