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Zin Z Htike, Francesco Zaccardi, Dimitris Papamargaritis, David R Webb, Kamlesh Khunti, Melanie J Davies
AIMS: To compare efficacy and safety of glucagon-like peptide-1 receptor agonists (GLP-1RAs) in subjects with type 2 diabetes MATERIALS AND METHODS: We electronically searched, up to June 3(rd) , 2016, published randomised clinical trials lasting between 24 and 32 weeks and comparing a GLP-1RA (albiglutide, dulaglutide, twice-daily (EBID) and once-weekly exenatide, liraglutide, lixisenatide, semaglutide, and taspoglutide) with placebo or another GLP-1RA. Data on cardiometabolic and safety outcomes were analysed using a mixed-treatment comparison meta-analysis RESULTS: 34 trials (14464 participants) met the inclusion criteria; no published data for semaglutide were available...
December 15, 2016: Diabetes, Obesity & Metabolism
Milan Kvapil
New antidiabetic drugs are being developed today that expand the range of pharmacological intervention, in particular for patients with type 2 diabetes (imeglimin, semaglutide, dulaglutide, FGF 21 analogue). At the same time innovations take place that "better" the well-proven molecules, they offer new application forms we have no experience of diabetology (osmotic pump for exenatide, faster acting insulin aspart). New properties are brought by just the change of concentration (insulin glargine in a concentration of 300 U/ml), unexpected positive results are also brought by new fixed-ratio combinations of antidiabetics (fixed-ratio combination of insulin degludec and liraglutide, fixed-ratio combination of insulin glargine and lixisenatide)...
2016: Vnitr̆ní Lékar̆ství
Peter L Thompson, Timothy M E Davis
PURPOSE: The purpose of this study was to review the results of clinical trials assessing the cardiovascular effects of drugs for type 2 diabetes and the cardiovascular effects of newer available drugs. METHODS: We performed a detailed search of PubMed-listed publications, reports from international meetings, and ongoing studies from clinical FINDINGS: Currently available drugs have neutral or, in some cases, negative effects on cardiovascular outcomes...
November 15, 2016: Clinical Therapeutics
Jennifer M Trujillo, Sara A Wettergreen, Wesley A Nuffer, Samuel L Ellis, Michael T McDermott
Cardiovascular (CV) disease remains the leading cause of death in people with diabetes, highlighting the importance of using treatment options that do not increase CV risk or possibly decrease CV outcomes. Since 2008, the Food and Drug Administration has required demonstration of CV safety for all new medications developed for the glycemic management of diabetes. Seven trials have been published that have established CV safety for three DPP-4 inhibitors (alogliptin, saxagliptin, and sitagliptin), three GLP-1 receptor agonists (liraglutide, lixisenatide, and semaglutide), and one sodium-glucose cotransporter-2 inhibitor (empagliflozin)...
December 2016: Diabetes Technology & Therapeutics
James H Flory, Jenny K Ukena, James S Floyd
PURPOSE OF REVIEW: The purpose is to review evidence on cardiovascular risks and benefits of new treatments for type 2 diabetes mellitus. RECENT FINDINGS: In response to guidance issued by the Food and Drug Administration, thousands of patients have been enrolled in large randomized trials evaluating the cardiovascular effects of the three newest diabetes drug classes: glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose cotransporter 2 (SGLT-2) inhibitors, and dipeptidyl peptidase-4 (DPP-4) inhibitors...
December 2016: Current Atherosclerosis Reports
Gregory B Lim
No abstract text is available yet for this article.
December 2016: Nature Reviews. Cardiology
Steven P Marso, Stephen C Bain, Agostino Consoli, Freddy G Eliaschewitz, Esteban Jódar, Lawrence A Leiter, Ildiko Lingvay, Julio Rosenstock, Jochen Seufert, Mark L Warren, Vincent Woo, Oluf Hansen, Anders G Holst, Jonas Pettersson, Tina Vilsbøll
Background Regulatory guidance specifies the need to establish cardiovascular safety of new diabetes therapies in patients with type 2 diabetes in order to rule out excess cardiovascular risk. The cardiovascular effects of semaglutide, a glucagon-like peptide 1 analogue with an extended half-life of approximately 1 week, in type 2 diabetes are unknown. Methods We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks...
November 10, 2016: New England Journal of Medicine
Sudesna Chatterjee, Kamlesh Khunti, Melanie J Davies
The global epidemic of type 2 diabetes (T2DM) continues largely unabated due to an increasingly sedentary lifestyle and obesogenic environment. A cost-effective patient-centred approach, incorporating glucose-lowering therapy and modification of cardiovascular risk factors, could help prevent the inevitable development and progression of macrovascular and microvascular complications. Glycaemic optimization requires patient structured education, self-management and empowerment, and psychological support along with early and proactive use of glucose lowering therapies, which should be delivered in a system of care as shown by the Chronic Care Model...
June 2016: Best Practice & Research. Clinical Endocrinology & Metabolism
Sanjay Kalra, Yashdeep Gupta
This article introduces the concept of "weekend therapy", which has now become reality in diabetes. It briefly describes injectable and oral drugs which are currently available, or are in advanced stages of development, for use in once weekly administration. These include dulaglutide, exenatide QW, semaglutide, omarigliptin and trelagliptin.
May 2016: JPMA. the Journal of the Pakistan Medical Association
Sanjay Kalra, Manash P Baruah, Rakesh K Sahay, Ambika Gopalakrishnan Unnikrishnan, Shweta Uppal, Omolara Adetunji
Glucagon-like peptide-1 (GLP-1)-based therapy improves glycaemic control through multiple mechanisms, with a low risk of hypoglycaemia and the additional benefit of clinically relevant weight loss. Since Starling and Bayliss first proposed the existence of intestinal secretions that stimulate the pancreas, tremendous progress has been made in the area of incretins. As a number of GLP-1 receptor agonists (GLP-1 RAs) continue to become available, physicians will soon face the challenge of selecting the right option customized to their patient's needs...
March 2016: Indian Journal of Endocrinology and Metabolism
Francesco Zaccardi, Zin Zin Htike, David R Webb, Kamlesh Khunti, Melanie J Davies
BACKGROUND: Once-weekly glucagon-like peptide-1 receptor agonists (GLP-1RAs) are new drugs for the treatment of type 2 diabetes. PURPOSE: To summarize evidence for the cardiometabolic efficacy and adverse effects of once-weekly GLP-1RAs in adults with type 2 diabetes. DATA SOURCES: Electronic databases (PubMed, Web of Science, Cochrane Central Register of Controlled Trials, U.S. Food and Drug Administration, European Medicines Agency, ClinicalTrials...
January 19, 2016: Annals of Internal Medicine
Michael A Nauck, John R Petrie, Giorgio Sesti, Edoardo Mannucci, Jean-Pierre Courrèges, Marie L Lindegaard, Christine B Jensen, Stephen L Atkin
OBJECTIVE: To investigate the dose-response relationship of semaglutide versus placebo and open-label liraglutide in terms of glycemic control in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: This was a 12-week, randomized, double-blind phase 2 trial. Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1...
February 2016: Diabetes Care
Jesper Lau, Paw Bloch, Lauge Schäffer, Ingrid Pettersson, Jane Spetzler, Jacob Kofoed, Kjeld Madsen, Lotte Bjerre Knudsen, James McGuire, Dorte Bjerre Steensgaard, Holger Martin Strauss, Dorte X Gram, Sanne Møller Knudsen, Flemming Seier Nielsen, Peter Thygesen, Steffen Reedtz-Runge, Thomas Kruse
Liraglutide is an acylated glucagon-like peptide-1 (GLP-1) analogue that binds to serum albumin in vivo and is approved for once-daily treatment of diabetes as well as obesity. The aim of the present studies was to design a once weekly GLP-1 analogue by increasing albumin affinity and secure full stability against metabolic degradation. The fatty acid moiety and the linking chemistry to GLP-1 were the key features to secure high albumin affinity and GLP-1 receptor (GLP-1R) potency and in obtaining a prolonged exposure and action of the GLP-1 analogue...
September 24, 2015: Journal of Medicinal Chemistry
Christoph Kapitza, Leszek Nosek, Lene Jensen, Helle Hartvig, Christine B Jensen, Anne Flint
The effect of semaglutide, a once-weekly human glucagon-like peptide-1 (GLP-1) analog in development for type 2 diabetes (T2D), on the bioavailability of a combined oral contraceptive was investigated. Postmenopausal women with T2D (n = 43) on diet/exercise ± metformin received ethinylestradiol (0.03 mg)/levonorgestrel (0.15 mg) once daily for 8 days before (semaglutide-free) and during (steady-state 1.0 mg) semaglutide treatment (subcutaneous once weekly; dose escalation: 0.25 mg 4 weeks; 0...
May 2015: Journal of Clinical Pharmacology
Carsten F Gotfredsen, Anne-Marie Mølck, Inger Thorup, Niels C Berg Nyborg, Zaki Salanti, Lotte Bjerre Knudsen, Marianne O Larsen
Increased pancreas mass and glucagon-positive adenomas have been suggested to be a risk associated with sitagliptin or exenatide therapy in humans. Novo Nordisk has conducted extensive toxicology studies, including data on pancreas weight and histology, in Cynomolgus monkeys dosed with two different human glucagon-like peptide-1 (GLP-1) receptor agonists. In a 52-week study with liraglutide, a dose-related increase in absolute pancreas weight was observed in female monkeys only. Such dose-related increase was not found in studies of 4, 13, or 87 weeks' duration...
July 2014: Diabetes
Matteo Monami, Ilaria Dicembrini, Camilla Nardini, Irene Fiordelli, Edoardo Mannucci
AIMS: Several randomized trials with metabolic outcomes have reported that glucagon like peptide-1 receptor agonists (GLP-1 RA) could be associated with an increased risk of pancreatitis. The present meta-analysis aimed to examine this hypothesis. METHODS: An extensive Medline, Embase, and Cochrane Database search for "exenatide", "liraglutide", "albiglutide", "taspoglutide", "dulaglutide", "lixisenatide", and "semaglutide" was performed up to March 31st, 2013. INCLUSION CRITERIA: (i) randomized trials, (ii) duration ≥12 weeks; (iii) on type 2 diabetes; and (iv) comparison of GLP-1RA with placebo or active drugs...
February 2014: Diabetes Research and Clinical Practice
Matteo Monami, Ilaria Dicembrini, Niccolò Marchionni, Carlo M Rotella, Edoardo Mannucci
Glucagon-Like Peptide-1 receptor agonists (GLP-1RAs), approved as glucose-lowering drugs for the treatment of type 2 diabetes, have also been shown to reduce body weight. An extensive Medline, Cochrane database, and Embase search for "exenatide," "liraglutide," "albiglutide," "semaglutide," and "lixisenatide" was performed, collecting all randomized clinical trials on humans up to December 15, 2011, with a duration of at least 24 weeks, comparing GLP-1 receptor agonists with either placebo or active drugs. Twenty two (7,859 patients) and 7 (2,416 patients) trials with available results on body weight at 6 and 12 months, respectively, were included...
2012: Experimental Diabetes Research
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