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Diabetes, Obesity & Metabolism

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https://www.readbyqxmd.com/read/29770552/variability-of-insulin-degludec-and-glargine-u300-a-matter-of-methodology-or-just-marketing
#1
Tim Heise, Sascha Heckermann, J Hans DeVries
The variability in the time-action profiles of insulin preparations, in particular basal insulins, has been a matter of debate ever since the publication of a glucose clamp study comparing the day-to-day variability of three different basal insulins (glargine U100, detemir and NPH) in 2004 [1]. While critics did not contest the findings of a lower variability of some basal insulins in this and a later [2] glucose clamp study, they did question the relevance of a lower pharmacokinetic (PK) and pharmacodynamic (PD) variability for clinical endpoints [3, 4]...
May 17, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29770541/effect-of-short-term-treatment-with-sitagliptin-or-glibenclamide-on-daily-glucose-fluctuation-in-drug-na%C3%A3-ve-japanese-patients-with-type-2-diabetes-mellitus
#2
Ryo Suzuki, Jun-Ichi Eiki, Takashi Moritoyo, Kenichi Furihata, Akira Wakana, Yukari Ohta, Shigeru Tokita, Takashi Kadowaki
AIMS: To compare the effect of a dipeptidyl peptidase-4 inhibitor (DPP4-i) and a sulfonylurea (SU) on daily glucose fluctuation in drug-naïve Japanese patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: Fifty-three drug-naïve Japanese patients with T2DM (HbA1c of 7.0% to 9.0% and fasting plasma glucose of 6.1 mmol/L or higher) were randomly assigned to either sitagliptin 50 mg q.d. or glibenclamide 2.5 mg per day (given in divided doses) in a 1:1 ratio...
May 17, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29766636/empagliflozin-as-add-on-to-linagliptin-in-a-fixed-dose-combination-in-japanese-patients-with-type-2-diabetes-glycemic-efficacy-and-safety-profile-in-a-52-week-randomized-placebo-controlled-trial
#3
Ryuzo Kawamori, Masakazu Haneda, Keiko Suzaki, Gang Cheng, Kosuke Shiki, Yuki Miyamoto, Fernando Solimando, Christopher Lee, Jisoo Lee, Jyothis George
AIMS: This double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg as add-on to linagliptin (Lina) 5 mg (fixed-dose combination, Empa/Lina 10/5 or 25/5) in insufficiently controlled Japanese type 2 diabetes patients. METHODS: The trial (40 sites; May 2015-March 2017) screened 433 adults (≥20 years) who were treatment-naive or on one oral antidiabetic drug for ≥12 weeks (discontinued at enrolment)...
May 15, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29766635/efficacy-and-safety-of-mk-1293-insulin-glargine-compared-with-originator-insulin-glargine-lantus-in-type-1-diabetes-a-randomized-open-label-clinical-trial
#4
Philip D Home, Raymond L H Lam, Wendy L Carofano, Gregory T Golm, Roy Eldor, Michael F Crutchlow, Michael C Marcos, Julio Rosenstock, Priscilla A Hollander, Baptist Gallwitz
AIMS: Comparison of the efficacy and safety of MK-1293 insulin glargine (Mk-Gla; 100 U/ml) with originator insulin glargine, Lantus (Sa-Gla) in people with type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: This phase 3, randomized, active-controlled, open-label, 52-week study enrolled 508 people with T1DM (HbA1c ≤ 11.0%; 97 mmol/mol) taking basal and prandial insulin. Participants were randomized 1:1 to once-daily Mk-Gla (n=245) or Sa-Gla (n=263). Dose titration of basal insulin was by a pre-breakfast plasma glucose dosing algorithm...
May 15, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29766634/semaglutide-induces-weight-loss-in-subjects-with-type-2-diabetes-regardless-of-baseline-bmi-or-gastrointestinal-adverse-events-in-sustain-1-5-trials
#5
Bo Ahrén, Stephen L Atkin, Guillaume Charpentier, Mark L Warren, John Ph Wilding, Sune Birch, Anders Gaarsdal Holst, Lawrence A Leiter
AIMS: Semaglutide, a new once-weekly glucagon-like peptide 1 analogue for the treatment of type 2 diabetes, demonstrated superior reductions in HbA1c and superior weight loss (by 2.3-6.3 kg) versus different comparators across the SUSTAIN 1-5 trials; the contributing factors to weight loss are not established. This post hoc analysis assessed the effect of baseline body mass index (BMI), and of occurrence of nausea and/or vomiting, on semaglutide-induced weight loss. MATERIALS AND METHODS: Subjects with inadequately controlled type 2 diabetes (drug-naïve or on background treatment) were randomized to subcutaneous semaglutide 0...
May 15, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29766633/empagliflozin-as-adjunct-to-insulin-in-japanese-participants-with-type-1-diabetes-results-of-a-4-week-double-blind-randomized-placebo-controlled-phase-2-trial
#6
Akira Shimada, Toshiaki Hanafusa, Atsutaka Yasui, Ganghyuck Lee, Yusuke Taneda, Akiko Sarashina, Kosuke Shiki, Jyothis George, Nima Soleymanlou, Jan Marquard
AIMS: This phase 2, double-blind, randomized, placebo-controlled trial (4 sites in Japan) investigated the pharmacodynamics (PD), pharmacokinetics (PK), and safety profile of empagliflozin in Japanese participants with type 1 diabetes mellitus (T1DM) as adjunctive therapy to insulin. MATERIALS AND METHODS: Participants on multiple daily injections of insulin for ≥12 months with an HbA1c of 7.5%-10.0%, entered a 2-week, open-label, placebo run-in period followed by a 4-week, double-blind period where participants were randomized 1:1:1:1 to receive empagliflozin 2...
May 15, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29761615/efficacy-and-safety-of-mk-1293-insulin-glargine-compared-with-originator-insulin-glargine-lantus-in-type-2-diabetes-a-randomized-open-label-clinical-trial
#7
Priscilla A Hollander, Wendy L Carofano, Raymond L H Lam, Gregory T Golm, Roy Eldor, Michael F Crutchlow, Michael C Marcos, Marc S Rendell, Philip D Home, Baptist Gallwitz, Julio Rosenstock
AIMS: To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) in people with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: This Phase 3, randomized, active-controlled, open-label, 24-week clinical trial enrolled 531 participants with T2DM (HbA1c ≤11.0%) eligible for or currently taking basal insulin (≥10 U/day). Participants were randomized 1:1 to once-daily Mk-Gla (n=263) or Sa-Gla (n=263). Titration of insulin was guided by a fasting plasma glucose (FPG)-based dosing algorithm...
May 14, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29756388/semaglutide-for-type-2-diabetes-mellitus-a-systematic-review-and-meta-analysis
#8
Panagiotis Andreadis, Thomas Karagiannis, Konstantinos Malandris, Ioannis Avgerinos, Aris Liakos, Apostolos Manolopoulos, Eleni Bekiari, David R Matthews, Apostolos Tsapas
AIM: To assess the efficacy and safety of semaglutide, a recently approved glucagon-like peptide 1 receptor agonist (GLP-1 RA) for type 2 diabetes. METHODS: We searched major electronic databases and grey literature sources for randomised controlled trials comparing semaglutide with placebo or other antidiabetic agents. Primary outcome was change from baseline in HbA1c . Secondary endpoints included change from baseline in body weight, blood pressure, heart rate, and incidence of hypoglycaemia, gastrointestinal adverse effects, pancreatitis and diabetic retinopathy...
May 13, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29756322/european-medicines-agency-approval-of-new-glucose-lowering-medicines-for-type-2-diabetes
#9
Clifford J Bailey
Since 2005 all new glucose-lowering medicines to be used in Europe have required approval by the European Medicines Agency (EMA) through a centralised procedure [1]. This involves assessment of a detailed file of data generated during the preclinical studies and phase 1-3 clinical trials, along with the proposed product label. The file is subject to internal review and some aspects may also receive external review, giving rise to questions that are referred back to the sponsor and may lead to additional studies...
May 13, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29752759/metformin-targets-brown-adipose-tissue-in-vivo-and-reduces-oxygen-consumption-in-vitro
#10
Peter Breining, Jonas B Jensen, Elias I Sundelin, Lars C Gormsen, Steen Jakobsen, Morten Busk, Lars Rolighed, Peter Bross, Paula Fernandez-Guerra, Lasse K Markussen, Nanna E Rasmussen, Jacob B Hansen, Steen B Pedersen, Bjørn Richelsen, Niels Jessen
Metformin is the most widely prescribed oral antidiabetic drug worldwide. Despite well-documented beneficial effects on health outcomes in diabetic patients, the target organs that mediate the effects of metformin remain to be established. In adult humans, brown adipose tissue (BAT) can influence basic metabolic rate, making BAT an attractive target for treatment of type 2 diabetes. Under the hypothesis that BAT is a metformin target tissue, we investigated in vivo uptake of [11 C]-metformin tracer in mice and studied in vitro effects of metformin on cultured human brown adipocytes...
May 12, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29748996/exposure-response-analysis-for-evaluation-of-semaglutide-dose-levels-in-type-2-diabetes
#11
Kristin C C Petri, Steen H Ingwersen, Anne Flint, Jeppe Zacho, Rune V Overgaard
AIMS: Semaglutide is a glucagon-like peptide-1 analogue approved for the treatment of type 2 diabetes. To evaluate dose levels, we examined the effects of demographic factors on efficacy and safety in an exposure-response analysis. METHODS: We analysed data from 1552 adults from four randomised phase 3 trials of 30-56 weeks' duration investigating once-weekly semaglutide doses 0.5 and 1.0 mg. Exposure-response relationships were investigated using graphical and model-based techniques to assess the two dose levels and subgroups with the highest and lowest exposure and response...
May 11, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29748994/hypothalamic-arcuate-nucleus-glucokinase-regulates-insulin-secretion-and-glucose-homeostasis
#12
Yue Ma, Risheka Ratnasabapathy, Chioma Izzi-Engbeaya, Marie-Sophie Nguyen-Tu, Errol Richardson, Sufyan Hussain, Ivan De Backer, Christopher Holton, Mariana Norton, Gaelle Carrat, Blanche Schwappach, Guy A Rutter, Waljit S Dhillo, James Gardiner
AIMS: Glucokinase (GK) serves as a glucose sensor in several tissues including glucose-sensitive neurons of the arcuate nucleus within the hypothalamus. We have previously demonstrated a role for arcuate GK in the regulation of food and glucose intake. However, its role in the regulation of glucose homeostasis is less clear. We therefore sought to investigate the role of arcuate GK in the regulation of glucose homeostasis. MATERIALS AND METHODS: Recombinant adeno-associated virus expressing either GK or an antisense GK construct was used to alter GK activity specifically in the hypothalamic arcuate nucleus...
May 11, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29749099/this-is-in-reply-to-letter-by-dr-chanaka-n-kahathuduwa-et-al-titled-unaccounted-for-regression-to-the-mean-renders-conclusion-of-article-titled-uric-acid-lowering-in-relation-to-hba1c-reductions-with-the-sglt2-inhibitor-tofogliflozin-unsubstantiated
#13
LETTER
Motoshi Ouchi, Kenzo Oba, Hideki Suganami, Akihiro Yoshida, Tomoe Fujita, Tatsuya Suzuki, Masahiro Yasutake, Kohei Kaku
We thank Dr. Chanaka N. Kahathuduwa and colleagues for their thoughtful comments on our recent article [1] appearing in Diabetes, Obesity and Metabolism. We completely understand Dr. Chanaka N. Kahathuduwa et al.'s points [2]. Certainly, leading to the conclusion based only on the impact of regression to the mean, RTM might generally be insufficient. In this study, we also included supplemental information and figures [1], in addition to the results of the multivariate analysis in subjects who received tofogliflozin...
May 10, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29749030/a-new-therapeutic-approach-for-type-1-diabetes-rationale-for-gnbac1-an-anti-herv-w-env-monoclonal-antibody
#14
REVIEW
Francois Curtin, Corinne Bernard, Sandrine Levet, Hervé Perron, Hervé Porchet, Julie Médina, Sam Malpass, David Lloyd, Richard Simpson
We describe a newly identified therapeutic target for type 1 diabetes: an envelope protein of endogenous retroviral origin called Human Endogenous Retrovirus W Envelope (HERV-W-Env). HERV-W-Env was found to be detected in the blood of around 60% of type 1 diabetes (T1D) patients and is expressed in acinar pancreatic cells of 75% of T1D patients at post-mortem examination. Preclinical experiments showed that this protein displays direct cytotoxicity on human β-islet cells. In vivo HERV-W-Env impairs the insulin and glucose metabolism in transgenic mice expressing HERV-W-Env...
May 10, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29740969/peripheral-cannabinoid-1-receptor-blockade-mitigates-adipose-tissue-inflammation-via-nlrp3-inflammasome-in-mouse-models-of-obesity
#15
Ji Hye Han, Hanho Shin, Jun Gi Rho, Jung-Eun Kim, Dong Hwee Son, Juhwan Yoon, Yong Jae Lee, Jung-Hyuck Park, Byung Jeong Song, Chang-Sik Choi, Seul Gi Yoon, Il Yong Kim, Eun Kyung Lee, Je Kyung Seong, Ki Woo Kim, Wook Kim
AIMS: Cannabinoid 1 receptor (CB1R) antagonists have been shown to improve insulin resistance and the associated metabolic abnormalities, but their therapeutic development was discontinued due to neuropsychiatric side effects. This study evaluated AJ5018 as the peripherally restricted CB1R antagonist, synthesized by modifying the structure of its brain-penetrant parent compound rimonabant, and analyzed the metabolic parameters and adipose tissue inflammation via NLRP3 inflammasome following chronic treatment of mouse models of obesity with AJ5018...
May 8, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29740935/the-european-medicines-agency-s-approval-of-new-medicines-for-type-2-diabetes
#16
REVIEW
Eberhard Blind, Heidi Janssen, Kristina Dunder, Pieter A de Graeff
Since 2005 more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consisted of 15 new active substances establishing three new classes of non-insulin products, several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralised procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy...
May 8, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29740922/association-of-hypoglycaemia-and-cardiac-arrhythmia-risk-in-patients-with-diabetes-mellitus-a-systematic-review-and-meta-analysis
#17
Claire Fitzpatrick, Sudesna Chatterjee, Samuel Seidu, Danielle H Bodicoat, G Andre Ng, Melanie J Davies, Kamlesh Khunti
AIMS: Hypoglycaemia is associated with increased cardiovascular risk amongst individuals with diabetes mellitus. It has been hypothesised that hypoglycaemia may trigger autonomic changes leading to increased cardiac arrhythmia risk. We conducted a systematic review and meta-analysis to explore this association. MATERIALS AND METHODS: Ovid Medline, Embase, Scopus, Web of Science and Cochrane were searched from inception to October 10, 2017. We included studies of adults with diabetes (Type 1 or Type 2) which compared acute electrocardiogram (ECG) changes during episodes of hypoglycaemia and euglycaemia...
May 8, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29732725/time-trends-and-geographical-variation-in-prescribing-of-drugs-for-diabetes-in-england-1998-2017
#18
Helen J Curtis, John M Dennis, Beverley M Shields, Alex J Walker, Seb Bacon, Andrew T Hattersley, Angus G Jones, Ben Goldacre
AIMS: UK guidelines for type II diabetes leave the choice of glucose lowering therapies after metformin largely to prescribers. They vary greatly in cost, and comparative effectiveness data is lacking. We set out to measure the variation in prescribing of these second-line non-insulin diabetes drugs. MATERIALS AND METHODS: We evaluated time trends 1998-2016, using England's publicly available prescribing datasets, and stratified by the order prescribed to patients using the Clinical Practice Research Datalink (CPRD)...
May 7, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29732718/impact-of-treatment-with-pioglitazone-on-stroke-outcomes-a-real-world-database-analysis
#19
Christopher Ll Morgan, Silvio E Inzucchi, Jorge Puelles, Sara Jenkins-Jones, Craig J Currie
AIMS: Randomised controlled trials have reported an association between pioglitazone and reduced incidence of stroke in type 2 diabetic (T2DM) and insulin-resistant populations. We investigated this association within a real-world database. MATERIALS AND METHODS: T2DM patients initiating pioglitazone between 2000-2012 were extracted from the Clinical Practice Research Datalink (CPRD); a UK routine. Two non-exposed control cohorts were matched on age, gender, HbA1c, diabetes duration, stroke history, co-morbidities and prior T2DM regimen...
May 7, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29732679/free-and-fixed-ratio-combinations-of-basal-insulin-and-glp-1-receptor-agonists-versus-basal-insulin-intensification-in-type-2-diabetes-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#20
Maria Ida Maiorino, Paolo Chiodini, Giuseppe Bellastella, Lorenzo Scappaticcio, Miriam Longo, Katherine Esposito, Dario Giugliano
We provide a meta-analysis of randomized controlled trials (RCTs) comparing free or fixed combination of a GLP-1RA plus basal insulin versus insulin intensification on metabolic control in patients with type 2 diabetes. We searched electronic databases for RCTs assessing changes in HbA1c, proportion of patients at HbA1c target of <7% (53 mmol/mol), hypoglycaemia, and weight change. We used a random-effect model to calculate the weighted mean difference (WMD) or relative risk (RR) with the 95% CI. We identified 11 RCTs, lasting 24-30 weeks, and involving 6176 patients...
May 7, 2018: Diabetes, Obesity & Metabolism
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