Selected Publications

A narrative commentary about interoperability in medical devices and datat used in diabetes therapy from an academic EU/UK/US perspective. Johan Jendle, Peter Adolfsson, Pratik Choudhary, Klemen Dovc, Alexander Fleming, David C. Klonoff, Julia K. Mader, Nick Oliver, Jennifer L. Sherr, Jan Šoupal & Lutz Heinemann
A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings. David C. Klonoff, MD, FACP, FRCP (Edin), Jing Wang, PhD, MPH, RN, FAAN, David Rodbard, MD, Alexander Fleming, MD, et. al. (March 2022)
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. (January 2020)
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. (April 2019)
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). (December 2019)
A Regulatory Pathway for Medicines that Target Aging by Kinexum authors and Nir Barzilai in Public Policy & Aging Report. (September 2019)
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. (August 2019)
Diabetes App Wild West: EASD/ADA Group Hopes to Spur Change Marlene Busko. (October 2019)
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. al. (May 2019)
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. (April 2019)
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. (April 2019)
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. (December 2018)
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. (May 2017)
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. (January 2017)
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. (July 2016)
Metformin – associated lactic acidosis: Current perspectives on causes and risk Ralph DeFronzo, G. Alexander Fleming, Kim Chen, Thomas A. Bicsak. (October 2015)
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. (October 2015)
Assessing Rates of Hypoglycemia as an End Point in Clinical Trials Douglas B.Muchmore, Lutz Heinemann, William Tamborlane, Xionghua W. Wu, Alexander Fleming. (October 2015)
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. (March 2015)
Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, and Cardiometabolic Disorders G. Alexander Fleming BS, MD. (November 2014)
Hepatotoxicity of tyrosine kinase inhibitors: clinical and regulatory perspectives Shah RR, Morganroth J, Shah DR. (April 2013)
Cardiovascular safety of tyrosine kinase inhibitors: with a special focus on cardiac repolarisation (QT interval) Shah RR, Morganroth J, Shah DR. (April 2013)
Tyrosine kinase inhibitors: their on-target toxicities as potential indicators of efficacy Shah DR, Shah RR, Morganroth J. (April 2013)
A Fresh Perspective on Comparing the FDA and the CHMP/EMA: Approval of antineoplastic tyrosine kinase inhibitors. Shah RR, Roberts SA, Shah DR. (January 2013)
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. (December 2012)
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. (November 2012)
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. (August 2012)
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. (August 2012)
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. (July 2012)
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. (July 2012)
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. (June 2012)
Diet and exercise for weight loss. Bray GA. JAMA. 2012 Jun 27;307(24):2641-2. (June 2012)
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. (May 2012)
Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval H-G Eichler, et al. (March 2012)
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. (March 2012)
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. (January 2012)
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. (December 2010)
United Health Center for Health Reform & Modernization, The United States of Diabetes: Challenges and Opportunities in the Decade Ahead (November 2010)
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. (September 2009)
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. (March 2009)
What will it take to get therapies approved for type 1 diabetes? Ann N Y Acad Sci. 2008 Dec; 1150:25-31. Fleming A. (December 2008)
Prospects and Challenges for Islet Regeneration 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. (March 2007)
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. (January 2004)
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. (April 2003)
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. (2000)
Optimizing Therapeutic Development in Diabetes, Greenwich Medical Media, 1999. G. Alexander Fleming, MD, et al. (July 1999)

Selected Publications

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Illustration 84415960 © Rostislav Zatonskiy | Dreamstime.com

Selected Publications

Follow Us

© 2021 All Rights ReservedIllustration 84415960 © Rostislav Zatonskiy | Dreamstime.com

© 2021 All Rights Reserved
Illustration 84415960 © Rostislav Zatonskiy | Dreamstime.com