Selected Publications

• The Digitisation of Diabetes: Opportunities and Challenges for Industry. Contributions by Alexander Fleming, MD, Athena Philis-Tsimikas, MD, Heidi Soto, and Professor Mike Trenell FirstWorld Reports (March 2020)
• The Need for Precision Medicine to be Applied to Diabetes. Alexander Fleming, MD, David C. Klonoff, MD, FACP, FRCP (Edin), Jose C. Florez, MD, PhD, and Michael German, MD.
• Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes. David C. Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE, Alberto Gutierrez, PhD, Alexander Fleming, et. al.
• Diabetes digital app technology: benefits, challenges, and recommendations. A consensus report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group. G. Alexander Fleming, John R. Petrie, Richard M. Bergenstal, Reinhard W. Holl, Anne L. Peters, Lutz Heinemann. Diabetologia (https://doi.org/10.1007/s00125-019-05034-1) and Diabetes Care (https://doi.org/10.2337/dci19-0062)
• Culinary Medicine: Advancing a Framework for Healthier Eating to Improve Chronic Disease Management and Prevention Hirsch Irl B., MD1; Alison Evert, MS, RD, CDE2; Alexander Fleming, MD3; Linda M. Gaudiani, MD, FACP, FACE4; Karl J. Guggenmos, MBA, AAC5; Daniel I. Kaufer, MD6; Janet B. McGill, MD, MA, FACE7; Carol A. Verderese, BA8; and Joe Martinez, RPh, PDE, CMS9
• Diabetes App Wild West: EASD/ADA Group Hopes to Spur Change Marlene Busko
• Chapter 19, Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, Nonalcoholic Steatohepatitis (NASH) and Other Cardiometabolic Disorders G. Alexander Fleming and Brian E. Harvey, Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease
• A Regulatory Pathway for Medicines that Target Agingby Kinexum authors and Nir Barzilai in Public Policy & Aging Report
• Impact of Insulin Tregopil and Its Permeation Enhancer on Pharmacokinetics of Metformin in Healthy Volunteers: Randomized, Open‐Label, Placebo‐Controlled, Crossover Study Anand Khedkar, Harold Lebovitz, Alexander Fleming, Alan Cherrington, Vinu Jose, Sandeep N. Athalye, Ashwini Vishweswaramurthy
• Implementation of Basal–Bolus Therapy in Type 2 Diabetes: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch with an Insulin Pen Richard M. Bergenstal, Mark Peyrot, Darlene M. Dreon, Vanita R. Aroda, Timothy S. Bailey, Ronald L. Brazg, Juan P. Frias, Mary L. Johnson, David C. Klonoff, Davida F. Kruger, Julio Rosenstock, Shenaz Ramtoola, Pierre Serusclat, Ruth S. Weinstock, Ramachandra G. Naik, et. all.
• Real-World Evidence Should be Used in Regulatory Decisions about New Pharmaceutical and Medical Device Products for Diabetes David C. Klonoff, Alberto Gutierrez, Alexander Fleming, and David Kerr. 
• Hypoglycemia Evaluation and Reporting in Diabetes: Importance for the Development of New Therapies David C.Klonoff, G.Alexander Fleming, Douglas B.Muchmore, Brian M.Frier  
• Update and Next Steps for Real - World Translation of Interventions for Type 2 Diabetes Prevention: Reflections From a Diabetes Care Editors' Forum William T. Cefalu, John B. Buse, Jaakko Tuomilehto, G. Alexander Fleming, Ele Ferrannini, Hertzel C. Gerstein, Peter H. Bennett, Ambady Ramachandran, Itamar Raz, Julio Rosenstock, Steven E. Kahn
• Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of a Drug under Development Friedrich Mittermayer, Erica Caveney, Claudia De Oliveira, G.Alexander Fleming, Loukas Gourgiotis, Mala Puri, Li-Jung Tai and J.Rick Turner
• Metformin - associated lactic acidosis: Current perspectives on causes and risk Ralph DeFronzo, G. Alexander Fleming, Kim Chen, Thomas A. Bicsak
• Alternate Approaches for Pediatric Type 1 Diabetes Drug Development and Potential Regulatory Approval: A Perspective  J.Rick Turner, Kelly L. Close G. Alexander Fleming, Diane K. Wherrett and Linda A. DiMeglio
• Assessing Rates of Hypoglycemia as an End Point in Clinical Trials Douglas B.Muchmore, Lutz Heinemann, William Tamborlane, Xionghua W. Wu, Alexander Fleming
• Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group  Lutz Heinemann, G.Alexander Fleming, John R.Petrie, Reinhard W. Holl, Richard M. Bergenstal, Anne L. Peters
• Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, and Cardiometabolic Disorders  G.Alexander Fleming BS,MD
• Hepatotoxicity of tyrosine kinase inhibitors: clinical and regulatory perspectives  Shah RR, Morganroth J, Shah DR.
• Cardiovascular safety of tyrosine kinase inhibitors: with a special focus on cardiac repolarisation (QT interval)  Shah RR, Morganroth J, Shah DR.
• Tyrosine kinase inhibitors: their on-target toxicities as potential indicators of efficacy  Shah DR, Shah RR, Morganroth J.
• A Fresh Perspective on Comparing the FDA and the CHMP/EMA: Approval of antineoplastic tyrosine kinase inhibitors.  Shah RR, Roberts SA, Shah DR.
• Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval H-G Eichler, et al.
• A less invasive surgical approach for splanchnic nerve stimulation to treat obesity. Zheng J, Sonnier T, Vase A, Korivi N, Ajmera P, Morrison SF, DiLorenzo DJ, Greenway FL. Obes Surg. 2012 Nov;22(11):1783-4.
• Bariatric surgery and prevention of type 2 diabetes in Swedish obese subjects. Carlsson LM, Peltonen M, Ahlin S, Anveden Å, Bouchard C, Carlsson B, Jacobson P, Lönroth H, Maglio C, Näslund I, Pirazzi C, Romeo S, Sjöholm K, Sjöström E, Wedel H, Svensson PA, Sjöström L. N Engl J Med. 2012 Aug 23;367(8):695-704
• Challenges in developing endpoints for type 1 diabetes intervention studies. Diabetes Metab Res Rev. 2009 Nov;25(8):694-704. Review.Cernea S, Raz I, Herold KC, Hirshberg B, Roep BO, Schatz DA, Fleming GA, Pozzilli P, Little R, Schloot NC, Leslie RD, Skyler JS, Palmer JP; D-Cure Workshop.
• Comparing the effects of nano-sized sugarcane fiber with cellulose and psyllium on hepatic cellular signaling in mice. Wang ZQ, Yu Y, Zhang XH, Floyd ZE, Boudreau A, Lian K, Cefalu WT. Int J Nanomedicine. 2012;7:2999-3012.
• C-peptide is the appropriate outcome measure for type 1 diabetes clinical trials to preserve beta-cell function: report of an ADA workshop, 21-22 October 2001. Diabetes. 2004 Jan;53(1):250-64. Erratum in: Diabetes. 2004 Jul;53(7):1934. Palmer JP, Fleming GA, Greenbaum CJ, Herold KC, Jansa LD, Kolb H, Lachin JM, Polonsky KS, Pozzilli P, Skyler JS, Steffes MW.
• Diet and exercise for weight loss. Bray GA. JAMA. 2012 Jun 27;307(24):2641-2. Glutamic Acid decarboxylase therapy for recent-onset type 1 diabetes: are we at the end or the beginning of finding a cure? J Diabetes Sci Technol. 2009 Mar 1;3(2):215-8, Fleming GA, Klonoff DC.
• Effect of dietary protein content on weight gain, energy expenditure, and body composition during overeating: a randomized controlled trial. Bray GA, Smith SR, de Jonge L, Xie H, Rood J, Martin CK, Most M, Brock C, Mancuso S, Redman LM. JAMA. 2012 Jan 4;307(1):47-55.
• Efficacy of Olibra: a 12-week randomized controlled trial and a review of earlier studies. Rebello CJ, Martin CK, Johnson WD, O'Neil CE, Greenway FL. J Diabetes Sci Technol. 2012 May 1;6(3):695-708.
• Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Stenlöf K, Cefalu WT, Kim KA, Alba M, Usiskin K, Tong C, Canovatchel W, Meininger G. Diabetes Obes Metab. 2012 Dec 26. doi: 10.1111/dom.12054. [Epub ahead of print]
• Energy content of weight loss: kinetic features during voluntary caloric restriction. Heymsfield SB, Thomas D, Martin CK, Redman LM, Strauss B, Bosy-Westphal A,Müller MJ, Shen W, Martin Nguyen A. Metabolism. 2012 Jul;61(7):937-43.
• Look AHEAD Research Group. Lifestyle change and mobility in obese adults with type 2 diabetes. Rejeski WJ, Ip EH, Bertoni AG, Bray GA, Evans G, Gregg EW, Zhang Q. N Engl J Med. 2012 Mar 29;366(13):1209-17.
• Maintaining a high physical activity level over 20 years and weight gain. Hankinson AL, Daviglus ML, Bouchard C, Carnethon M, Lewis CE, Schreiner PJ, Liu K, Sidney S. JAMA. 2010 Dec 15;304(23):2603-10.
• Optimizing Therapeutic Development in Diabetes, Greenwich Medical Media, 1999. G. Alexander Fleming, MD, et al.as a treatment for diabetes: a review of islet neogenesis associated protein. J Diabetes Sci Technol. 2007 Mar;1(2):231-44. Fleming A, Rosenberg L.
• Prospects and challenges for islet regeneration
• Recombinant variant of ciliary neurotrophic factor for weight loss in obese adults: a randomized, dose-ranging study. Ettinger MP, Littlejohn TW, Schwartz SL, Weiss SR, McIlwain HH, Heymsfield SB, Bray GA, Roberts WG, Heyman ER, Stambler N, Heshka S, Vicary C, Guler HP. JAMA. 2003 Apr 9;289(14):1826-32.
• Reducing the glycemic index or carbohydrate content of mixed meals reduces postprandial glycemia and insulinemia over the entire day but does not affect satiety. Liu AG, Most MM, Brashear MM, Johnson WD, Cefalu WT, Greenway FL. Diabetes Care. 2012 Aug;35(8):1633-7.
• Regulatory Considerations in the Development of Therapies for Diabetic Nephropathy and Related Conditions in the Kidney and Hypertension in Diabetes Mellitus, CE Morgensen Editor Kluwer Academic Publishers, Boston, 2000 Fleming GA.
• Single-dose pharmacokinetics of different oral sodium nitrite formulations in diabetes patients. Greenway FL, Predmore BL, Flanagan DR, Giordano T, Qiu Y, Brandon A, Lefer DJ, Patel RP, Kevil CG. Diabetes Technol Ther. 2012 Jul;14(7):552-60.
• United Health Center for Health Reform & Modernization, The United States of Diabetes: Challenges and Opportunities in the Decade Ahead
• What will it take to get therapies approved for type 1 diabetes? Ann N Y Acad Sci. 2008 Dec; 1150:25-31. Fleming A.