Saxagliptin for type 2 diabetes

References

• Onglyza [package insert] Princeton, NJ/Wilmington, DE Bristol-Myers Squibb Company/AstraZeneca Pharmaceuticals LP 7 2009
   Google Scholar
• Januvia [package insert] Whitehouse Station, NJ Merck and Co., Inc. 2 2010
   Google Scholar
• Galvus [European Public Assessment Report] West Sussex, UK Novartis Europharm Limited Available from: http://www.ema.europa.eu/humandocs/Humans/EPAR/galvus/galvus.htm Accessed Jun 8, 2010
   Google Scholar
• Augeri DJ Robl JA Betebenner DA Discovery and preclinical profile of Saxagliptin (BMS-477118): A highly potent, long-acting, orally active dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes J Med Chem 2005 48 15 5025 5037 16033281
   PubMed Web of Science ®Google Scholar
• Fura A Khanna A Vyas V Pharmacokinetics of the dipeptidyl peptidase 4 inhibitor saxagliptin in rats, dogs, and monkeys and clinical projections Drug Metab Dispos 2009 37 6 1164 1171 19251818
   PubMed Web of Science ®Google Scholar
• Rosenstock J Aguilar-Salinas C Klein E CV181-011 Study Investigators Effect of saxagliptin monotherapy in treatment-naive patients with type 2 diabetes Curr Med Res Opin 2009 25 10 2401 2411 19650754
   PubMed Web of Science ®Google Scholar
• Jadzinsky M Pfützner A Paz-Pacheco E CV181-039 Investigators Saxagliptin given in combination with metformin as initial therapy improves glycemic control in patients with type 2 diabetes compared with either monotherapy: A randomized controlled trial Diabetes Obes Metab 2009 11 6 611 622 19515181
   PubMed Web of Science ®Google Scholar
• Rosenstock J Sankoh S List JF Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes Diabetes Obes Metab 2008 10 5 376 386 18355324
   PubMed Web of Science ®Google Scholar
• DeFronzo RA Hissa M Garber AJ Saxagliptin 014 Study Group The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes on metformin alone Diabetes Care 2009 32 9 1649 1655 19478198
   PubMed Web of Science ®Google Scholar
• Chacra AR Tan GH Apanovitch A Ravichandran S List J Chen R Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: A randomised controlled trial Int J Clin Pract 2009 63 9 1395 1406 19614786
   PubMed Web of Science ®Google Scholar
• Hollander P Li J Allen E Chen R CV181-013 Investigators Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone J Clin Endocrinol Metab 2009 94 12 4810 4819 19864452
   PubMed Web of Science ®Google Scholar
• Drucker DJ The biology of incretin hormones Cell Metab 2006 3 3 153 165 16517403
   PubMed Web of Science ®Google Scholar
• Tahrani AA Piya MK Barnett AH Saxagliptin: A new DPP-4 inhibitor for the treatment of type 2 diabetes mellitus Adv Ther 2009 26 3 249 262 19330494
   PubMed Web of Science ®Google Scholar
• Ahrén B Landin-Olsson M Jansson PA Svensson M Holmes D Schweizer A Inhibition of dipeptidyl peptidase-4 reduces glycemia, sustains insulin levels, and reduces glucagon levels in type 2 diabetes J Clin Endocrinol Metab 2004 89 5 2078 2084 15126524
   PubMed Web of Science ®Google Scholar
• Barnett A DPP-4 inhibitors and their potential role in the management of type 2 diabetes Int J Clin Pract 2006 60 11 1454 1470 17073841
   PubMed Web of Science ®Google Scholar
• Baggio LL Drucker DJ Biology of incretins: GLP-1 and GIP Gastroenterology 2007 132 6 2131 2157 17498508
   PubMed Web of Science ®Google Scholar
• Drucker DJ The role of gut hormones in glucose homeostasis J Clin Invest 2007 117 1 24 32 17200703
   PubMed Web of Science ®Google Scholar
• Kirby MS Dorso C Wang A In vitro enzymologic characteristics of saxagliptin, a highly potent and selective DPP4 inhibitor with ‘slow binding’ characteristics Abstract presented at: 3rd International Conference on Dipeptidyl Peptidase and Related Proteins 2008, Apr 23–25 Antwerp, Belgium
   Google Scholar
• Kirby M Yu DM O’Connor S Gorrell MD Inhibitor selectivity in the clinical application of dipeptidyl peptidase-4 inhibition Clin Sci (Lond) 2010 118 1 31 41 19780719
   PubMed Web of Science ®Google Scholar
• Wang A Dorso C Kopcho L Marcinkeviciene J Kirby MS Implications of the prolonged dissociation rate of saxagliptin, a highly potent and selective DPP4 inhibitor, on plasma DPP measurements [ADA Abstr 2088-PO] Diabetes 2008 57 Suppl 1 A576 A577
   Google Scholar
• Boulton D Geraldes M Safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily oral doses of saxagliptin for 2 weeks in type 2 diabetic and healthy subjects Diabetes 2009 56 Suppl 1 606P
   Google Scholar
• Henry R Smith S Schwartz S List JF Duan Y Chen R β-cell stimulation by saxagliptin in patients with type 2 diabetes Diabetes 2009 58 Suppl 1 A119
   Google Scholar
• Boulton D Goyal A Li L Kornhauser D Frevert E The effects of age and gender on the single-dose pharmacokinetics and safety of saxagliptin in healthy subjects [ADA Abstr 551-P] Diabetes 2008 57 Suppl 1 A165
   Google Scholar
• Patel C Castaneda L Frevert U Li L Kornhauser DM Boulton DW Single-dose pharmacokinetics and safety of saxagliptin in subjects with hepatic impairment compared with healthy subjects [ADA Abstr 537-P] Diabetes 2008 57 Suppl 1 A160
   Google Scholar
• Patel CG Zhang J Li L Effect of a high-fat meal on the pharmacokinetics of saxagliptin in healthy subjects J Clin Pharmacol 2010 Feb 11 [Epub ahead of print]
   Web of Science ®Google Scholar
• Patel CG Boulton DW Brenner E Royzman K Li L Effect of ketoconazole on the pharmacokinetics of saxagliptin in healthy subjects J Clin Pharmacol 2007 47 Abstr 89
   Web of Science ®Google Scholar
• Girgis S Patel C Li L Effect of diltiazem on the pharmacokinetics of saxagliptin in healthy subjects J Clin Pharmacol 2007 47 Abstr 72
   Web of Science ®Google Scholar
• Girgis S You X Li L Maurer C Whigan D Boulton DW Effect of simvastatin on the pharmacokinetics of saxagliptin in healthy subjects J Clin Pharmacol 2007 47 Abstr 28
   Web of Science ®Google Scholar
• Patel CG Wolf RA Komoroski B Li L Boulton DW No meaningful pharmacokinetic drug-drug interaction between saxagliptin and pioglitazone in healthy subjects Poster presented at: The American College of Clinical Pharmacy Annual Meeting 2007 Oct 14–17 Denver, CO Abstr 226
   Google Scholar
• Patel CG Komoroski B Li L Boulton DW No meaningful pharmacokinetic drug-drug interaction between saxagliptin and glyburide in healthy subjects Poster presented at: The American College of Clinical Pharmacy Annual Meeting 2007 Oct 14–17 Denver, CO Abstr 212
   Google Scholar
• Patel CG Komoroski B Brenner E Li L Boulton DW No meaningful pharmacokinetic drug-drug interactions between saxagliptin and metformin in healthy subjects Poster presented at: The American College of Clinical Pharmacy (ACCP) 2007 Oct 14–17 Denver, CO Abstr 213
   Google Scholar
• Boulton DW Li L Patel CG No pharmacokinetic interaction between saxagliptin and digoxin in healthy subjects [Abstr PIII-69] Clin Pharmacol Ther 2008 83 Suppl 1 S93
   Google Scholar
• Boulton DW Adams D Li L Maalox® Max, famotidine or omeprazole do not meaningfully affect the pharmacokinetics of saxagliptin in healthy subjects Clin Pharmacol Ther 2008 83 Suppl 1 S92
   Google Scholar
• DeFronzo R Hissa MN Garber AJ Duan RY Ravichandran S Chen R Once-daily saxagliptin added to metformin provides sustained glycemic control and is well tolerated over 102 weeks in patients with type 2 diabetes [ADA Abstr 547-P] Diabetes 2009 58 Suppl 1 A147
   Google Scholar
• Maheux P Doucet J Allen E Efficacy and safety of saxagliptin 5 mg once-daily therapy in elderly patients with type 2 diabetes mellitus [EASD Abstr 766-P] Diabetologia 2009 52 Suppl 1 S302
   Google Scholar
• Nesto RW Bell D Bonow RO Thiazolidinedione use, fluid retention, and congestive heart failure: A consensus statement from the American Heart Association and American Diabetes Association Diabetes Care 2004 27 1 256 263 14693998
   PubMed Web of Science ®Google Scholar
• Chen R Donovan M Rusnak JM Saxagliptin used as monotherapy or in combination with other antihyperglycemic agents does not significantly increase risk of hypoglycemia [ADA Abstr 2082-PO] Diabetes 2009 58 Suppl 1 A536
   Google Scholar
• US Food and Drug Administration Guidance for industry: Diabetes mellitus –evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes Silver Spring, MD Center for Drug Evaluation and Research 12 2008
   Google Scholar
• Frederich R Alexander TH Fiedorek FT A systematic assessment of cardiovascular outcomes in the saxagliptin drug development program for type 2 diabetes Postgrad Med 2010 122 3 16 27 20463410
   PubMed Web of Science ®Google Scholar
• Bristol-Myers Squibb/AstraZeneca Does saxagliptin reduce the risk of cardiovascular events when used alone or added to other diabetes medications (SAVOR-TIMI 53) ClinicalTrialsgov [Internet] Bethesda (MD) National Library of Medicine (US) 2010 [cited 2010 May 4]. Available from: http://clinicaltrials.gov/ct2/show/NCT01107886. NLM Identifier: NCT01107886 Accessed on Jun 30, 2010
   Google Scholar
• Rodbard HW Jellinger PS Davidson JA Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: An algorithm for glycemic control Endocr Pract 2009 15 6 541 559
   Web of Science ®Google Scholar
• Asociación Latinoamericana de Diabetes Guías ALAD de diagnóstico control y tratamiento de la diabetes mellitus tipo 2 Available from: http://www.sld.cu/galerias/pdf/sitios/diabetes/guias_alad_de_diagnostico_y_tratamiento_de_la_diadetes_tipo_2(2006.pdf) Accessed on Mar 25, 2010
   Google Scholar
• Nathan DM Buse JB Davidson MB Medical management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes Diabetes Care 2009 32 1 193 203 18945920
   PubMed Web of Science ®Google Scholar
• Mendes AB Fittipaldi JA Neves RC Chacra AR Moreira EDJr Prevalence and correlates of inadequate glycaemic control: Results from a nationwide survey in 6,671 adults with diabetes in Brazil Acta Diabetol 2010 47 2 137 145 19655083
   PubMed Web of Science ®Google Scholar
• Resnick HE Foster GL Bardsley J Ratner RE Achievement of American Diabetes Association clinical practice recommendations among US adults with diabetes, 1999–2002: The National Health and Nutrition Examination Survey Diabetes Care 2006 29 3 531 537 16505501
   PubMed Web of Science ®Google Scholar
• Hoerger TJ Segel JE Gregg EW Saaddine JB Is glycemic control improving in US adults? Diabetes Care 2008 31 1 81 86 17934153
   PubMed Web of Science ®Google Scholar