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Exenatide ones week

Anna Rydén, Stephanie Chen, Emuella Flood, Beverly Romero, Susan Grandy
INTRODUCTION: Methods for discrete choice experiment (DCE) attribute and attribute-level selection have not yet been firmly established and are rarely reported in detail. This paper describes a qualitative study designed to inform the development of a DCE survey designed to examine preferences for glucagon-like peptide-1 receptor agonist (GLP-1RA) treatments among patients with type 2 diabetes mellitus. METHODS: The study involved a literature review, interviews with clinical experts, and interviews with GLP-1RA-experienced (i...
March 17, 2017: Patient
Michael Horowitz, Vanita R Aroda, Jenny Han, Elise Hardy, Chris K Rayner
AIMS: To characterize gastrointestinal adverse events (AEs) with different glucagon-like peptide-1 receptor agonists (GLP-1RAs). METHODS: Two retrospective intention-to-treat analyses of 6-month patient-level data were conducted. Data from three studies comparing exenatide once weekly (n = 617) with exenatide twice daily (n = 606) were pooled, and one (DURATION-6) comparing exenatide once weekly (n = 461) with liraglutide (n = 450) was analysed separately...
January 6, 2017: Diabetes, Obesity & Metabolism
Emma Mead, Greg Atkinson, Bernd Richter, Maria-Inti Metzendorf, Louise Baur, Nicholas Finer, Eva Corpeleijn, Claire O'Malley, Louisa J Ells
BACKGROUND: Child and adolescent obesity has increased globally, and can be associated with significant short- and long-term health consequences. OBJECTIVES: To assess the efficacy of drug interventions for the treatment of obesity in children and adolescents. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, PubMed (subsets not available on Ovid), LILACS as well as the trial registers ICTRP (WHO) and Searches were undertaken from inception to March 2016...
November 29, 2016: Cochrane Database of Systematic Reviews
Brenda Cirincione, Jeffrey Edwards, Donald E Mager
Exenatide is a glucagon-like peptide-1 receptor agonist with both immediate- and extended-release (ER) formulations that are approved for the treatment of type 2 diabetes mellitus. Long-term exposure from the ER formulation is achieved through slow peptide release from a degradable microsphere formulation. The goal of this analysis was to develop a pharmacokinetic model for the ER formulation following single and once-weekly multiple-dose administration. Pharmacokinetic data were collected from two clinical trials-one that evaluated single-dose administration of 2...
March 2017: AAPS Journal
Puxiu Wang, Qian Wang, Tianyang Ren, Haoyu Gong, Jingxin Gou, Yu Zhang, Cuifang Cai, Xing Tang
Pluronic F127 and PEG as a multi-gel-core were used to prepare Exenatide-loaded microspheres and store the drug within the microspheres. Also, the sol-gel transition and novel functions of the Pluronic F127-PEG gel core were investigated.Microspheres with a multi-gel-core (GCMs) and without a multi-gel-core (Ms) were compared in terms of the rate of PLGA degradation, therelease kinetics in vitro and the efficacy in KKAy mice. The drug release of GCMs was at a constant rate, and slower than Ms. In addition, after the KKAy mice were given Exenatide for 55days, the blood glucose concentration and HbA1c concentration in the GCMs group were lower than that in the Ms group...
November 1, 2016: Colloids and Surfaces. B, Biointerfaces
Viorica Ionut, Orison O Woolcott, Hasmik J Mkrtchyan, Darko Stefanovski, Morvarid Kabir, Malini S Iyer, Huiwen Liu, Ana V B Castro, Qiang Wu, Josiane L Broussard, Cathryn M Kolka, Isaac Asare-Bediako, Richard N Bergman
BACKGROUND: Exenatide's effects on glucose metabolism have been studied extensively in diabetes but not in pre-diabetes. OBJECTIVE: We examined the chronic effects of exenatide alone on glucose metabolism in pre-diabetic canines. DESIGN AND METHODS: After 10 weeks of high-fat diet (HFD), adult dogs received one injection of streptozotocin (STZ, 18.5 mg/kg). After induction of pre-diabetes, while maintained on HFD, animals were randomized to receive either exenatide (n = 7) or placebo (n = 7) for 12 weeks...
2016: PloS One
Tiansheng Wang, Fei Wang, Junwen Zhou, Huilin Tang, Sharon Giovenale
BACKGROUND: Recent cardiovascular outcome trials of incretin based therapies (IBT) in type 2 diabetes have not demonstrated either benefit or harm in terms of major adverse cardiovascular events (MACE). Earlier meta-analyses showed conflicting results but were limited in methodology. We aimed to perform an updated meta-analysis of all available incretin therapies on the incidence of MACE plus arrhythmia and heart failure. METHODS: We identified studies published through November 2014 by searching electronic databases and reference lists...
April 2, 2016: Diabetes/metabolism Research and Reviews
Shaoyong Xu, Xiangyang Liu, Jie Ming, Qiuhe Ji
BACKGROUND: Apart from the mean level of glycemic control, the extent of glucose excursions is another important issue to consider in type 2 diabetes mellitus (T2DM) management. Studies have showed that fluctuations of glucose seem to have more deleterious effects than sustained hyperglycemia in the development of diabetic complications as acute glucose swings activate the oxidative stress. However, until now, no randomized controlled trials have been conducted with the primary aim to evaluate glycemic fluctuation in the comparison between twice-daily exenatide and other treatment paradigms (for example, biphasic insulin aspart 30)...
March 24, 2016: Trials
Eric L Schneider, Jeff Henise, Ralph Reid, Gary W Ashley, Daniel V Santi
We have developed a unique long-acting drug-delivery system for the GLP-1 agonist exenatide. The peptide was covalently attached to Tetra-PEG hydrogel microspheres by a cleavable β-eliminative linker; upon s.c. injection, the exenatide is slowly released at a rate dictated by the linker. A second β-eliminative linker with a slower cleavage rate was incorporated in polymer cross-links to trigger gel degradation after drug release. The uniform 40 μm microspheres were fabricated using a flow-focusing microfluidic device and in situ polymerization within droplets...
May 18, 2016: Bioconjugate Chemistry
Fen Xu, Beisi Lin, Xiaobin Zheng, Zonglan Chen, Huanyi Cao, Haixia Xu, Hua Liang, Jianping Weng
AIMS/HYPOTHESIS: Accumulating evidence has revealed the significant role of glucagon-like peptide-1 (GLP-1) in weight loss. Sirtuin 1 (SIRT1) plays a vital role in the regulation of lipid metabolism. Here, we investigated the contribution of lipolytic and oxidative changes in white adipose tissue (WAT) to the weight-lowering effect induced by the GLP-1 receptor (GLP-1R) agonist exenatide (exendin-4) in mice. We also looked at the role of SIRT1 in this process. METHODS: C57BL/6J mice and Sirt1 (+/-) mice were treated with exenatide (24 nmol/kg) or an NaCl solution (154 mmol/l) control i...
May 2016: Diabetologia
Mei Hu, Yu Zhang, Nanxi Xiang, Ying Zhong, Tao Gong, Zhi-Rong Zhang, Yao Fu
PURPOSE: This study aimed to develop a sustained-release formulation of exenatide (EXT) for the long-term therapeutic efficacy in the treatment of type II diabetes. METHODS: In this study, we present an injectable phospholipid gel by mixing biocompatible phospholipid S100, medium chain triglyceride (MCT) with 85% (w/w) ethanol. A systemic pre-formulation study has been carried out to improve the stability of EXT during formulation fabrication. With the optimized formulation, the pharmacokinetic profiles in rats were studied and two diabetic animal models were employed to evaluate the therapeutic effect of EXT phospholipid gel via a single subcutaneous injection versus repeated injections of normal saline and EXT solution...
2016: Pharmaceutical Research
M Yu, K Van Brunt, O J Varnado, K S Boye
We evaluated patient-reported outcome (PRO) measures from the Assessment of Weekly AdministRation of LY2189265 (dulaglutide) in Diabetes (AWARD) clinical trial programme for dulaglutide (1.5 mg and 0.75 mg) in patients with type 2 diabetes (T2D). The Impact of Weight on Self-Perception (IW-SP), Impact of Weight on Ability to Perform Physical Activities of Daily Living (APPADL), Impact of Weight on Quality of Life-Lite, EQ-5D, Diabetes Treatment Satisfaction Questionnaire (DTSQ), Diabetes Symptom Checklist-Revised and Adult Low Blood Sugar Survey were administered and analysed for changes from baseline in one or more AWARD studies...
April 2016: Diabetes, Obesity & Metabolism
Sten Madsbad
Currently, six glucagon-like peptide-1 receptor agonists (GLP-1RAs) are approved for treating type 2 diabetes. These fall into two classes based on their receptor activation: short-acting exenatide twice daily and lixisenatide once daily; and longer-acting liraglutide once daily, exenatide once weekly, albiglutide once weekly and dulaglutide once weekly. The phase III trial of a seventh GLP-1RA, taspoglutide once weekly, was stopped because of unacceptable adverse events (AEs). Nine phase III head-to-head trials and one large phase II study have compared the efficacy and safety of these seven GLP-1RAs...
April 2016: Diabetes, Obesity & Metabolism
Sarah L Greig, Lesley J Scott
Insulin degludec/liraglutide (Xultophy(®)), a fixed-ratio combination of an ultra-long-acting insulin analogue and a glucagon-like protein-1 (GLP-1) receptor agonist, is available in the EU for the management of inadequately controlled type 2 diabetes. Once-daily subcutaneous insulin degludec/liraglutide as add-on therapy to oral antidiabetics was effective and generally well tolerated in adults with inadequately controlled type 2 diabetes in several well designed 26-week phase III trials. In insulin-naive patients, add-on insulin degludec/liraglutide provided significantly greater improvements in glycated haemoglobin (HbA1c) levels than add-on insulin degludec, liraglutide or placebo, or unchanged GLP-1 receptor agonists (i...
September 2015: Drugs
Yahiya Y Syed, Paul L McCormack
Exenatide extended-release (exenatide ER) [Bydureon(®)] is a glucagon-like peptide-1 receptor agonist, approved for the treatment of type 2 diabetes mellitus. It is injected subcutaneously by patients once weekly, with no dose titration required. This article updates an earlier review of exenatide ER in the management of type 2 diabetes, focusing on recently published data. In randomized, controlled trials, adjunctive exenatide ER 2 mg once weekly for 24-30 weeks significantly improved glycaemic control and reduced bodyweight in patients with inadequately controlled type 2 diabetes despite diet plus exercise and/or oral antihyperglycaemic drugs (OADs)...
July 2015: Drugs
Chune Zhu, Ying Huang, Xiaoying Zhang, Liling Mei, Xin Pan, Ge Li, Chuanbin Wu
The purpose of this study was to compare the properties of exenatide-loaded poly (D,L-lactic-co-glycolic acid) microparticles (Ex-PLGA-MPs) prepared by a novel ultra-fine particle processing system (UPPS) and spray drying. UPPS is a proprietary technology developed by our group based on the disk rotation principle. Characteristics of the MPs including morphology, particle size distribution, drug content, encapsulation efficiency and in vitro release were comparatively studied. Cytotoxicity of the MPs was examined on A549 cells and the pharmacodynamics was investigated in vivo in type 2 diabetes Sprague-Dawley (SD) rats...
August 1, 2015: Colloids and Surfaces. B, Biointerfaces
Ishma Aijazi, Fadhil M Abdulla, Beyla J Zuberi, Ahmed Elhassan
Exenatide is an incretin mimetic. It was approved by the federal drug authority in 2005 for the treatment of type-2 diabetes. Since it is a relatively new medicine clinicians have limited experience with regards to its side effects and safety profile. We report a 47 year old lady who presented with exenatide associated acute kidney injury. She had type-2 diabetes for 10 years with mild micro albuminuria and normal renal functions. She was also taking a stable dose of metformin, gliclazide, angiotensin converting enzyme inhibitor and diuretic for over a year and there was no history of any recent use of non-steroid anti-inflammatory medications...
October 2014: Journal of Ayub Medical College, Abbottabad: JAMC
Sanjoy K Paul, Julius Agbeve, David Maggs, Jennie H Best
BACKGROUND: Self-monitoring of blood glucose (SMBG) is used as a means to detect and prevent hypoglycemia in patients with diabetes. However, information on the longitudinal measures (trajectory) of SMBG-based pre- and postprandial glucose fluctuations over time in relation to hypoglycemia is limited. Among patients treated with exenatide once weekly (EQW) or insulin glargine (IG), this study compared SMBG profiles over 52 weeks between patients who did and did not experience hypoglycemia...
January 2016: Journal of Diabetes
Louis Kuritzky, Guillermo Umpierrez, Jean Marie Ekoé, Leonardo Mancillas-Adame, Laura Fernández Landó
BACKGROUND: Type 2 diabetes (T2D) is an increasingly common endocrine disorder that is characterized by chronic hyperglycemia and tissue compartment abnormalities, including macrovascular and microvascular complications. More than 90% of patients with T2D will be diagnosed and treated in the primary care setting. One of the relatively recent additions to the increasing array of approved antidiabetic medications is the glucagon-like peptide-1 receptor agonist class. Mechanisms of action for glucagon-like peptide-1 receptor agonists include: 1) stimulation of insulin secretion through β-cells, though only when glucose levels are elevated (hence, minimizing risk for hypoglycemia); 2) blunting of glucagon secretion; 3) increased satiety; and 4) decreased rate of release of gastric contents into the small intestine, thereby reducing glycemic load...
October 2014: Postgraduate Medicine
Sanjoy K Paul, David Maggs, Kerenaftali Klein, Jennie H Best
BACKGROUND: Glycemic control in patients with type 2 diabetes is a dynamic process, and changes in risk factors affecting the incidence of hypoglycemia are not well understood. This study explored the association of longitudinal interactive effects of clinical risk factors and concomitant medications on hypoglycemia risk in patients treated with insulin glargine (IG) or exenatide once weekly (EQW). METHODS: Pooled patient-level 52-week longitudinal data of treatment with EQW (n = 541) or IG (n = 223) from three controlled trials were analyzed...
January 2015: Journal of Diabetes
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