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https://www.readbyqxmd.com/read/28913602/devoting-attention-to-glucose-variability-and-hypoglycaemia-in-type-2-diabetes
#1
EDITORIAL
Martin K Rutter
In the Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE), insulin degludec was non-inferior to insulin glargine in terms of cardiovascular events and mortality. However, there were lower rates of severe hypoglycaemia with insulin degludec. DEVOTE investigators now extend these findings by presenting the results of two observational epidemiological analyses based on trial data. In the first of these analyses (DEVOTE 2), Zinman et al (Diabetologia DOI: 10...
September 15, 2017: Diabetologia
https://www.readbyqxmd.com/read/28913575/day-to-day-fasting-glycaemic-variability-in-devote-associations-with-severe-hypoglycaemia-and-cardiovascular-outcomes-devote-2
#2
Bernard Zinman, Steven P Marso, Neil R Poulter, Scott S Emerson, Thomas R Pieber, Richard E Pratley, Martin Lange, Kirstine Brown-Frandsen, Alan Moses, Ann Marie Ocampo Francisco, Jesper Barner Lekdorf, Kajsa Kvist, John B Buse
AIMS/HYPOTHESIS: The Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) was a double-blind, randomised, event-driven, treat-to-target prospective trial comparing the cardiovascular safety of insulin degludec with that of insulin glargine U100 (100 units/ml) in patients with type 2 diabetes at high risk of cardiovascular events. This paper reports a secondary analysis investigating associations of day-to-day fasting glycaemic variability (pre-breakfast self-measured blood glucose [SMBG]) with severe hypoglycaemia and cardiovascular outcomes...
September 15, 2017: Diabetologia
https://www.readbyqxmd.com/read/28913543/devote-3-temporal-relationships-between-severe-hypoglycaemia-cardiovascular-outcomes-and-mortality
#3
Thomas R Pieber, Steven P Marso, Darren K McGuire, Bernard Zinman, Neil R Poulter, Scott S Emerson, Richard E Pratley, Vincent Woo, Simon Heller, Martin Lange, Kirstine Brown-Frandsen, Alan Moses, Jesper Barner Lekdorf, Lucine Lehmann, Kajsa Kvist, John B Buse
AIMS/HYPOTHESIS: The double-blind Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) assessed the cardiovascular safety of insulin degludec. The incidence and rates of adjudicated severe hypoglycaemia, and all-cause mortality were also determined. This paper reports a secondary analysis investigating associations of severe hypoglycaemia with cardiovascular outcomes and mortality...
September 15, 2017: Diabetologia
https://www.readbyqxmd.com/read/28904247/efficacy-and-safety-of-subgroup-analysis-stratified-by-baseline-hba1c-in-a-japanese-phase-3-study-of-dulaglutide-0-75-mg-compared-with-insulin-glargine-in-patients-with-type-2-diabetes
#4
Shizuka Kaneko, Tomonori Oura, Akiko Matsui, Tomotaka Shingaki, Masakazu Takeuchi
The efficacy and safety of once-weekly dulaglutide 0.75 mg (dulaglutide) compared with once-daily insulin glargine (glargine) in Japanese patients with type 2 diabetes were evaluated according to subgroups stratified by baseline glycated hemoglobin (HbA1c) (≤8.5% or >8.5%). This exploratory analysis of a randomized, open-label, phase 3 study included 361 patients. In both HbA1c subgroups (patients with baseline HbA1c ≤8.5% or >8.5%), a statistically significantly greater reduction in HbA1c was observed in dulaglutide-treated patients compared with glargine-treated patients after 26 weeks of treatment (HbA1c ≤8...
September 14, 2017: Endocrine Journal
https://www.readbyqxmd.com/read/28895655/insulin-resistance-and-cardiovascular-outcomes-in-the-origin-trial
#5
Hertzel C Gerstein, Ele Ferrannini, Matthew C Riddle, Salim Yusuf
AIMS: In the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial, titrated doses of basal insulin glargine targeting fasting normoglycemia had a neutral effect on cardiovascular outcomes. The dose of insulin required to achieve normoglycemia provides a unique measurement of each individual's resistance to insulin's action, and was therefore used to examine the link between insulin resistance and cardiovascular outcomes. MATERIALS AND METHODS: Self-titration of insulin doses targeting a fasting plasma glucose < 5...
September 12, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28895030/type-2-diabetes-and-cardiovascular-prevention-the-dogmas-disputed
#6
Dario Giugliano, Maria Ida Maiorino, Giuseppe Bellastella, Katherine Esposito
In randomized controlled trials (RCTs), more intensive glucose control in patients with type 2 diabetes leads to a modest (9%) reduction in major cardiovascular events (MACE), associated with a 20% reduction of kidney events and 13% reduction of eye events. The FDA issued guidance in 2008 led to the conduct of numerous cardiovascular outcomes (CVOT) trials to assess cardiovascular safety of new antihyperglycemic therapies in patients with type 2 diabetes. The results of these trials show that insulin glargine, three different dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, alogliptin, and sitagliptin) and lixisenatide (a glucagon like peptide-1 receptor agonist) produce no significant difference in CVOT when compared with usual care or placebo...
September 11, 2017: Endocrine
https://www.readbyqxmd.com/read/28892956/short-term-efficacy-and-safety-of-insulin-glargine-in-type-2-diabetes-inadequately-controlled-with-single-or-two-oral-agents-a-prospective-open-label-study
#7
Ajay Aggarwal, Roopak Wadhwa
INTRODUCTION: Basal insulin is among the second line treatment options for Type 2 Diabetes Mellitus (T2DM). Efficacy and safety of basal insulin in patients of T2DM, uncontrolled with Oral Antidiabetic Agents (OAAs) remains understudied in the Indian setting. AIM: To assess the efficacy and safety of insulin glargine in patients with T2DM who have uncontrolled glycaemic levels despite single or two OAAs therapy. MATERIALS AND METHODS: In this prospective, open label study, T2DM patients above 40 years of age, having inadequate glycaemic control [Glycosylated Haemoglobin (HbA1c) above 8% and/or fasting glucose level of 140 mg/dl and above] with single or two OAAs over three consecutive months were included...
July 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28870034/-the-efficacy-and-safety-of-insulin-degludec-versus-insulin-glargine-in-insulin-naive-subjects-with-type-2-diabetes-results-of-a-chinese-cohort-from-a-multinational-randomized-controlled-trial
#8
Y M Mu, L X Guo, L Li, Y M Li, X J Xu, Q M Li, M T Xu, L Y Zhu, G Y Yuan, Y Liu, C Xu, Z J Wang, F X Shen, Y Luo, J Y Liu, Q F Li, W H Wang, X Y Lai, H F Xu, C Y Pan
Objective: To compare the safety and efficacy of insulin degludec (IDeg) with those of insulin glargine (IGlar) in insulin-naive subjects with type 2 diabetes (T2DM). Methods: This was a 26-week, randomized, open-label, parallel-group, treat-to-target trial in 560 Chinese subjects with T2DM (men/women: 274/263, mean age 56 years, mean diabetes duration 7 years) inadequately controlled on oral antidiabetic drugs (OADs). Subjects were randomized 2∶1 to once-daily IDeg (373 subjects) or IGlar(187 subjects), both in combination with metformin...
September 1, 2017: Zhonghua Nei Ke za Zhi [Chinese Journal of Internal Medicine]
https://www.readbyqxmd.com/read/28864965/pharmacological-management-of-gestational-diabetes-mellitus
#9
Geetha Mukerji, Denice S Feig
Gestational diabetes mellitus (GDM) is associated with an increased risk of adverse pregnancy outcomes in the setting of poor glycemic control. The initial management for GDM includes intensive lifestyle modification, which often requires behavioral and nutritional changes to optimize glycemic control. Pharmacotherapy for GDM is initiated when glycemic targets are not met. The rapid-acting bolus analogues aspart and lispro achieve postprandial targets with less hypoglycemia compared to regular insulin, with similar fetal outcomes...
September 2, 2017: Drugs
https://www.readbyqxmd.com/read/28864828/-severe-atypical-ketoacidosis-due-to-sglt2-inhibitor-therapy-two-case-reports
#10
T G K Breuer, K Kampmann, A Wutzler, C Steinfort, W Uhl, W E Schmidt, J J Meier
Two female patients were admitted due to ketoacidosis. Serum glucose was moderately elevated. The patients exhibited abdominal and neurologic symptoms. Treatment consisted of metformin, insulin glargin and empagliflozin, as well as glimepiride, insulin detemir and empagliflozin, respectively. Treatment with intravenous fluid replacement, insulin, glucose, potassium and buffer solution led to a normalisation of pH and serum glucose levels. Our report describes two cases of atypical ketoacidosis with moderately elevated serum glucose during sodium-glucose co-transporter-2 (SGLT2) inhibitor therapy...
September 1, 2017: Der Internist
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
#11
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/28846865/insulin-glargine-and-its-two-active-metabolites-a-sensitive-16pm-and-robust-simultaneous-hybrid-assay-coupling-immunoaffinity-purification-with-lc-ms-ms-to-support-biosimilar-clinical-studies
#12
Yang Xu, Li Sun, Melanie Anderson, Philippe Bélanger, Vincent Trinh, Patricia Lavallée, Bhavna Kantesaria, Marie-Josée Marcoux, Sheila Breidinger, Kevin P Bateman, Dina Goykhman, Eric J Woolf
MK-1293 is a newly approved follow-on/biosimilar insulin glargine for the treatment of Type 1 and Type 2 diabetics. To support pivotal clinical studies during biosimilar evaluation, a sensitive, specific and robust liquid chromatography and tandem mass spectrometry (LC-MS/MS) assay for the simultaneous quantification of glargine and its two active metabolites, M1 and M2 were developed. Strategies to overcome analytical challenges, so as to optimize assay sensitivity and improve ruggedness, were evolved, resulting in a fully validated LC-MS/MS method with a lower limit of quantification (LLOQ) at 0...
August 19, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28842165/chronic-kidney-disease-basal-insulin-glargine-and-health-outcomes-in-people-with-dysglycemia-the-origin-study
#13
Vasilios Papademetriou, Eric S Nylen, Michael Doumas, Jeff Probstfield, Johannes F E Mann, Richard E Gilbert, Hertzel C Gerstein
BACKGROUND: Early stages of chronic kidney disease are associated with an increased cardiovascular risk in patients with established type 2 diabetes and macrovascular disease. The role of early stages of chronic kidney disease on macrovascular outcomes in prediabetes and early type two diabetes mellitus is not known. In the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial, the introduction of insulin had no effect on cardiovascular outcomes compared to standard therapy...
August 22, 2017: American Journal of Medicine
https://www.readbyqxmd.com/read/28837885/effect-of-insulin-glargine-on-recreational-physical-activity-and-tv-viewing-analysis-of-the-randomised-origin-trial
#14
Tom Yates, Melanie J Davies, Hyejung Jung, Jackie Bosch, Giatgen A Spinas, Seamus Sreenan, Patrick Commerford, Hertzel C Gerstein
AIMS: To quantify whether insulin therapy, and concomitant weight gain, affects recreational physical activity and TV viewing time using data from the Outcomes Reduction with an Initial Glargine Intervention (ORIGIN) trial. METHODS: 12,537 insulin-naïve individuals with dysglycaemia were randomised to receive either basal insulin glargine or standard care and followed for a median of 6.2years. Complete recreational physical activity and TV viewing time questionnaires across baseline, 2year follow-up and study end were available for 8954 participants...
July 31, 2017: Diabetes Research and Clinical Practice
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/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
#16
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
#17
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
#18
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
#19
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
#20
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
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