Severe Insulin Resistance in Diabetes by Integritas Communications

SEVERE INSULIN RESISTANCE in Pathogenesis and Improved Patient Management

FRIDAY, MAY 3, 2013 5:15 am â&#x20AC;&#x201C; 5:45 am 5:45 am â&#x20AC;&#x201C; 7:30 am

Phoenix Convention Center

West 301D

Breakfast Symposium

This activity is sponsored by the American Association of Clinical Endocrinologists. Program management provided by Integritas Communications This activity is supported by an educational grant from Lilly USA, LLC. For further information regarding Lilly grant funding visit www.lillygrantoffice.com.

SEVERE INSULIN RESISTANCE IN DIABETES Pathogenesis and Improved Patient Management

Daniel Einhorn, MD, FACE, FACP Program Chair Clinical Professor of Medicine University of California, San Diego Diabetes and Endocrine Associates Medical Director, Scripps Whittier Diabetes Institute La Jolla, California

George Grunberger, MD, FACE, FACP Clinical Professor, Internal Medicine and Molecular Medicine & Genetics Wayne State University School of Medicine Detroit, Michigan Chairman, Grunberger Diabetes Institute Bloomfield Hills, Michigan

Robert R. Henry, MD Professor of Medicine University of California, San Diego Chief, Section of Diabetes, Endocrinology & Metabolism VA San Diego Healthcare System San Diego, California

Fernando Ovalle, MD, FACE Professor of Medicine Director, Diabetes and Glycemic Control Programs University of Alabama at Birmingham School of Medicine Birmingham, Alabama

FACULTY

SEVERE INSULIN RESISTANCE IN DIABETES Pathogenesis and Improved Patient Management

AGENDA 5:45 am – 5:50 am Introductions

and Preactivity Questionnaire

Daniel Einhorn, MD, FACE, FACP

5:50 am – 6:20 am Severe

Insulin Resistance in Patients With Diabetes: Pathogenesis and Patient Workups

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Robert R. Henry, MD

6:20 am – 6:55 am Optimizing

Insulin Therapy in Patients With Severe Insulin Resistance and Type 2 Diabetes

Fernando Ovalle, MD, FACE

6:55 am – 7:15 am Multimodal

Management of Patients With Severe Insulin Resistance and Type 2 Diabetes

George Grunberger, MD, FACE, FACP

7:15 am – 7:30 am Ask

the Experts Q&A and Postactivity Questionnaire

Daniel Einhorn, MD, FACE, FACP

SEVERE INSULIN RESISTANCE IN DIABETES Pathogenesis and Improved Patient Management

TARGET AUDIENCE This activity is intended for endocrinologists and other health care professionals who manage diabetic patients with marked insensitivity to the effects of insulin.

EDUCATIONAL OBJECTIVES • Evaluate potential causes of severe insulin resistance in diabetic patients and relationships with co-occurring conditions, such as obesity and dyslipidemia • Tailor high-dose insulin therapy to help achieve patient-centered glycemic targets in the setting of severe insulin resistance • Combine insulin with incretin-based pharmacologics, lifestyle modifications, and other medical interventions for diabetic patients with severe insulin resistance • Employ newer insulin-based treatments, techniques, and technologies, including concentrated formulations, continuous glucose monitoring, and continuous subcutaneous insulin infusion • Counsel patients with severely insulin-resistant diabetes on the importance of treatment adherence and addressing signs of hypoglycemia

NEEDS ASSESSMENT With increasing frequency, endocrinologists and other health care providers are encountering diabetic patients with severe insulin resistance—defined as total daily insulin requirements exceeding 2.0 units/kg/day to achieve glycemic control.1,2 Although some patients develop significant insensitivities to insulin because of genetic, autoimmune, or other relatively rare disorders, the majority of cases involve obesity and the range of associated metabolic disturbances.1,3,4 Indeed, one of the greatest challenges facing endocrinologists in the United States is the significant upward trend in average body mass index over the last 3 decades.5 Thus, practicing endocrinologists will benefit from evidence-based discussions on interdisciplinary management of diabetic patients with severe insulin resistance, including multimodal therapeutic regimens that can be carefully tailored to achieve patientcentered treatment goals.3,6,7

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Upon completion of these educational activities, participants will be better prepared to:

SEVERE INSULIN RESISTANCE IN DIABETES Pathogenesis and Improved Patient Management

1. Tritos NA, Mantzoros CS. Clinical review 97: Syndromes of severe insulin resistance. J Clin Endocrinol Metab. 1998;83(9):3025-3030. 2. Lane WS, Cochran EK, Jackson JA, et al. High-dose insulin therapy: is it time for U-500 insulin? Endocr Pract. 2009;15(1):71-79. 3. Brown A, Desai M, Taneja D, Tannock LR. Managing highly insulin-resistant diabetes mellitus: weight loss approaches and medical management. Postgrad Med. 2010;122(1):163-171. 4. DeFronzo RA. Insulin resistance, lipotoxicity, type 2 diabetes and atherosclerosis: the missing links. Diabetologia. 2010;53(7):1270-1287. 5. Ogden CL, Carroll MD, McDowell MA, Flegal KM. Obesity among adults in the United States—No statistically significant change since 2003–2004. NCHS data brief no 1. 2007. National Center for Health Statistics: Hyattsville, MD.

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6. Handelsman Y, Mechanick JI, Blonde L, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing diabetes mellitus comprehensive care plan. Endocr Pract. 2011;17 (suppl 2):1-53. 7. Cochran E, Musso C, Gorden P. The use of U-500 in patients with extreme insulin resistance. Diabetes Care. 2005;28(5):1240-1244.

ACCREDITATION STATEMENTS The American Association of Clinical Endocrinologists (AACE) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The American Association of Clinical Endocrinologists (AACE) designates this live activity for a maximum of 1.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

DECLARATION OF DISCLOSURE AND CONFLICTS OF INTEREST It is the policy of AACE to ensure balance, independence, objectivity and scientific rigor in all of its CME activities. Presentation content may include discussion of an unlabeled or an investigational use of a product. AACE requires that participating faculty disclose to the audience any product(s) and its use(s) discussed in the educational activity that are unapproved/unlabeled for the use by the FDA or still considered investigational in nature. Everyone who is in a position to control the content of an educational activity must disclose all relevant financial relationships. “Relevant financial relationships” are financial relationships in any amount occurring within the past 12 months that create a conflict of interest. AACE requires speakers, faculty, CME Committee and other individuals who are in a position to control the content of this educational activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest

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are thoroughly evaluated by AACE for fair balance, scientific objectivity of studies mentioned in the presentation and educational materials used as basis for content, and appropriateness of patient care recommendations. The intent of this disclosure is not to prevent a speaker with commercial affiliations from presenting, but rather to provide learners with information from which they may make their own judgments. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial influence.

CME ACCREDITATION COMMITTEE DISCLOSURES Dr. Myriam Allende-Vigo reports that she does not have any relevant financial relationships with any commercial interests. Dr. David S.H. Bell reports that he has received speaker honoraria from AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, and Novo Nordisk A/S, and consultant/speaker honoraria from Bristol-Myers Squibb and Takeda Pharmaceuticals North America, Inc. Dr. Felice A. Caldarella reports that he has received research compensation from Boehringer Ingelheim GmbH and Eli Lilly and Company, speaker honoraria from Santarus, Inc., and speaker honoraria and research compensation from Novo Nordisk A/S. Dr. Edward Chin reports that he does not have any relevant financial relationships with any commercial interests. Dr. Stephen R. Crespin reports that he has received speaker honoraria from Bristol-Myers Squibb/AstraZeneca and Merck & Co., Inc. Dr. Marc J. Laufgraben reports that he does not have any relevant financial relationships with any commercial interests. Dr. Virginia A. LiVolsi reports that she has received histopathology consultant fees from Veracyte, Inc. Dr. Dorothy S. Martinez reports that she does not have any relevant financial relationships with any commercial interests. Dr. Andrew R. Reikes reports that his spouse is an employee and stockholder of GlaxoSmithKline plc. Dr. Mushtaq A. Syed reports that he has received speaker honoraria from Novo Nordisk A/S.

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AACE has reviewed all disclosures and resolved or managed all identified conflicts of interest for this educational activity, as applicable.

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Dr. Joseph M. Tibaldi reports that he has received speaker honoraria from Daiichi-Sankyo Company, Limited and Merck & Co., Inc., and speaker/consultant honoraria from Novo Nordisk A/S. Dr. Dace L. Trence reports that she has received research grant support from Eli Lilly and Company and is a stockholder of Medtronic, Inc. and sanofi-aventis U.S. LLC.

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PROGRAM COMMITTEE DISCLOSURES Dr. Samuel Dagogo-Jack reports that he has received consultant honoraria from Amylin Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, and Santarus Inc. Dr. Dagogo-Jack has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Sandra Weber reports that she does not have any relevant financial relationships with any commercial interests. Dr. Weber has no identified conflicts of interest. Dr. Robert Zimmerman reports that he has received speaker honoraria from Johnson & Johnson Services, Inc., Merck & Co., Inc., Novo Nordisk A/S, and Santarus Inc. Dr. Zimmerman has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Alan J. Garber reports that he has received speaker/consultant/ Advisory Board honoraria and consultant fees from Daiichi Sankyo Company, Limited, Merck & Co., Inc., and Novo Nordisk A/S; speaker/ consultant honoraria and fees from Santarus, Inc.; consultant/Advisory Board honoraria and consultant fees from Boehringer Ingelheim GmbH, LipoScience, Inc., and Takeda Pharmaceuticals North America, Inc.; and consultant fees from Lexicon Pharmaceuticals, Inc., Tethys Bioscience, and Vivus Inc. Dr. Garber has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Jeffrey R. Garber reports that he does not have any relevant financial relationships with any commercial interests. Dr. Garber has no identified conflicts of interest.

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Dr. Lewis E. Braverman reports that he does not have any relevant financial relationships with any commercial interests. Dr. Braverman has no identified conflicts of interest.

Dr. Pauline M. Camacho reports that she has received research grant support for her role as Principal Investigator from Eli Lilly and Company and Amgen Inc., and speaker honoraria from Warner Chilcott. Dr. Camacho has an identified conflict of interest and it has been resolved accordingly. She has been advised by the AACE CME Accreditation Committee to base her presentation and recommendations on the best available, preferably published evidence/information. Dr. M. Kathleen Figaro reports that she does not have any relevant financial relationships with any commercial interests. Dr. Figaro has no identified conflicts of interest. Dr. W. Timothy Garvey reports that he has received research support and speaker honoraria from Merck & Co., Inc.; research support from Amylin Pharmaceuticals, Inc., and Weight Watchers International, Inc.; and Advisory Board honoraria from Alkermes, Daiichi-Sankyo Company, Limited, Janssen Pharmaceuticals, Inc., LipoScience Inc., Tethys Bioscience, and Vivus Inc. Dr. Garvey has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. George Grunberger reports that he has received speaker honoraria and research support for his role as Investigator from Amylin Pharmaceuticals, LLC, Eli Lilly and Company, Novo Nordisk A/S, and Valeritas, Inc.; speaker honoraria from Amarin Corp. and Santarus Inc.; and research support for his role as Investigator from GlaxoSmithKline plc. and Janssen Pharmaceuticals, Inc. He also reports that his presentation will not include discussion of any investigational or unlabeled use(s) of a product. Dr. Grunberger has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. *

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Dr. Felice A. Caldarella reports that he has received research compensation from Boehringer Ingelheim GmbH and Eli Lilly and Company, speaker honoraria from Santarus, Inc., and speaker honoraria and research compensation from Novo Nordisk A/S. Dr. Caldarella has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information.

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Dr. Chris K. Guerin reports that he has received speaker honoraria from Eli Lilly and Company, Novo Nordisk A/S, and Santarus Inc. Dr. Guerin has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Edward S. Horton reports that he has received speaker honoraria from Amarin Corp., Amylin Pharmaceuticals, Inc., Gilead, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., sanofi-aventis U.S. LLC, GI, Theracos, Inc., and Takeda Pharmaceuticals North America, Inc. Dr. Horton has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Michael Kleerekoper reports that he does not have any relevant financial relationships with any commercial interests. Dr. Kleerekoper has no identified conflicts of interest. Dr. Armand A. Krikorian reports that he has received consultant fees from sanofi-aventis U.S. LLC. Dr. Krikorian has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Norman Lavin reports that he has received speaker honoraria from Endo Pharmaceuticals Inc., Genentech, Inc., and Pfizer Inc. Dr. Lavin has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Jonathan D. Leffert reports that he has received speaker honoraria from Abbott Laboratories, and research grant support for his role as Investigator from Boehringer Ingelheim GmbH, Eli Lilly and Company, Novartis AG, and Novo Nordisk A/S. Dr. Leffert has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Janet B. McGill reports that she has received grant support for her role as Washington University Principal Investigator from Andromeda Biotech Ltd., Bristol-Myers Squibb/AstraZeneca, Mannkind Corporation, Novartis AG, Takeda Pharmaceuticals North America, Inc. and sanofiaventis U.S. LLC; speaker/advisor honoraria from Boehringer Ingelheim

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GmbH/Eli Lilly and Company and Merck & Company, Inc.; advisor honoraria from Abbott Laboratories, Halozyme Therapeutics, Janssen Pharmaceuticals Inc., and Novo Nordisk A/S; and consultant honoraria from Reata Pharmaceuticals Inc. and Vitae Pharmaceuticals. Dr. McGill has an identified conflict of interest and it has been resolved accordingly. She has been advised by the AACE CME Accreditation Committee to base her presentation and recommendations on the best available, preferably published evidence/information.

Dr. Nancy D. Perrier reports that she does not have any relevant financial relationships with any commercial interests. Dr. Perrier has no identified conflicts of interest. Dr. Rachel Pessah-Pollack reports that she does not have any relevant financial relationships with any commercial interests. Dr. Pessah-Pollack has no identified conflicts of interest. Dr. Susan L. Samson reports that she has received advisory board honoraria from Corcept Therapeutics and Ipsen. Dr. Samson has an identified conflict of interest and it has been resolved accordingly. She has been advised by the AACE CME Accreditation Committee to base her presentation and recommendations on the best available, preferably published evidence/information. Dr. Peter A. Singer reports that he does not have any relevant financial relationships with any commercial interests. Dr. Singer has no identified conflicts of interest. Dr. J. Woody Sistrunk reports that he does not have any relevant financial relationships with any commercial interests. Dr. Sistrunk has no identified conflicts of interest. Dr. Craig Stump reports that he does not have any relevant financial relationships with any commercial interests. Dr. Stump has no identified conflicts of interest. Dr. Guillermo Umpierrez reports that he does not have any relevant financial relationships with any commercial interests. Dr. Umpierrez has no identified conflicts of interest. Dr. Aaron I. Vinik reports that he has received speaker honoraria and consultant fees from Merck & Co., Inc., and consultant fees from Pfizer Inc. and Isis Pharmaceuticals, Inc. Dr. Vinik has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information.

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Dr. Eric A. Orzeck reports that he has received speaker honoraria from Novo Nordisk A/S. Dr. Orzeck has no identified conflicts of interest.

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Dr. Steven Waguespack reports that he does not have any relevant financial relationships with any commercial interests. Dr. Waguespack has no identified conflicts of interest. Dr. Nelson Watts reports that he has received Stock options/holdings/ royalties for his role as Co-founder/stockholder and director of Osteodynamics; speaker honoraria from Novartis AG and Warner Chilcott; consultant fees from Abbott Laboratories, Baxter, BristolMyers Squibb, Imagepace, Johnson & Johnson Services, Inc., Medpace, Novo Nordisk A/S, Pfizer Inc./Wyeth, and Quark Pharmaceuticals, Inc.; speaker honoraria and consultant fees from Amgen Inc. and Eli Lilly and Company; research support through his health system from NPS Pharmaceuticals; and consultant fees and research support through his health system from Merck & Co., Inc. Dr. Watts has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Sunil Wimalawansa reports that he does not have any relevant financial relationships with any commercial interests. Dr. Wimalawansa has no identified conflicts of interest. Dr. Kathleen Wyne reports that she has received speaker honoraria from Abbott Laboratories, Novo Nordisk A/S, and Santarus Inc. Dr. Wyne has an identified conflict of interest and it has been resolved accordingly. She has been advised by the AACE CME Accreditation Committee to base her presentation and recommendations on the best available, preferably published evidence/information. Dr. Farhad Zangeneh reports that he does not have any relevant financial relationships with any commercial interests. Dr. Zangeneh has no identified conflicts of interest. *Denotes individual is both a member of the Program Committee and the Faculty.

FACULTY DISCLOSURES Dr. Daniel Einhorn reports that he has received consultant honoraria from Bristol-Myers Squibb Company/AstraZeneca-Amylin Pharmaceuticals, LLC., Halozyme, Inc., and Novo Nordisk A/S; consultant honoraria and research grant support from Eli Lilly and Company; and research grant support from AstraZeneca, Janssen Pharmaceuticals, Inc., MannKind Corporation, sanofi-aventis U.S. LLC.,

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Dr. Robert R. Henry reports that he has received research grant support for his role as Principal Investigator and Advisory Board honoraria from Amylin Pharmaceuticals, LLC, AstraZeneca, and Bristol-Myers Squibb Company; consultant/Advisory Board honoraria from Amgen Inc., F. Hoffman La-Roche Ltd./Genentech, Inc., Gilead, Intarcia Therapeutics, Inc., and Novo Nordisk A/S; consultant honoraria from Isis Pharmaceuticals, Inc.; Advisory Board honoraria from Johnson & Johnson Services, Inc. and Merck & Co., Inc.; consultant/Advisory Board/speaker honoraria from Boehringer Ingelheim GmbH; research grant support for his role as Principal Investigator and consultant honoraria from Eli Lilly and Company and sanofi-aventis U.S. LLC.; and research grant support for his role as Principal Investigator from Medtronic, Inc. He also reports that his presentation will not include discussion of any investigational or unlabeled use(s) of a product. Dr. Henry has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information. Dr. Fernando Ovalle reports that he has received consultant fees and research support from Bristol-Myers Squibb Company, Janssen Pharmaceuticals, Inc., Medtronic, Inc., Novo Nordisk A/S, and sanofiaventis U.S. LLC. He also reports that his presentation will not include discussion of any investigational or unlabeled use(s) of a product. Dr. Ovalle has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information.

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and Takeda Pharmaceutical Company Limited. He also reports that his presentation will not include discussion of any investigational or unlabeled use(s) of a product. Dr. Einhorn has an identified conflict of interest and it has been resolved accordingly. He has been advised by the AACE CME Accreditation Committee to base his presentation and recommendations on the best available, preferably published evidence/information.

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LEARNER BILL OF RIGHTS The American Association of Clinical Endocrinologists (AACE) recognizes that you are a lifelong learner who has chosen to engage in continuing medical education to identify or fill a gap in knowledge, skill, or performance. As part of AACE’s duty to you as a learner, you have the right to expect that your continuing medical education experience with AACE includes:

CONTENT that: • Promotes improvements or quality in healthcare;

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• Is valid, reliable, and accurate; • Offers balanced presentations that are free of commercial bias for or against a product/service; • Is vetted through a process that resolves any conflicts of interests of planners, teachers, or authors; • Is driven and based on learning needs, not commercial interests; • Addresses the stated objectives or purpose; and • Is evaluated for its effectiveness in meeting the identified educational need.

A LEARNING ENVIRONMENT that: • Supports learners’ ability to meet their individual needs; • Respects and attends to any special needs of the learners; • Respects the diversity of groups of learners; and • Is free of promotional, commercial, and/or sales activities.

DISCLOSURE of: • Relevant financial relationships planners, teachers, and authors have with commercial interests related to the content of the activity; and • Commercial support (funding or in-kind resources) of the activity.

HOW TO CLAIM CREDIT To claim credit for this session, use the Claim Station located in the Phoenix Convention Center or online at www.prereg.net/2013/aace/ceu. Items needed to claim credit are your badge number and the four digit code for this session. The four-digit session codes are listed in the schedule-at-a-glance and in the program.

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SUGGESTED READING Golden SH, Sapir T. Methods for insulin delivery and glucose monitoring in diabetes: summary of a comparative effectiveness review. J Manag Care Pharm. 2012;18(6 suppl):S1-17. Gregg EW, Chen H, Wagenknecht LE, et al. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA. 2012;308:2489-2496. Grunberger G. Novel therapies for management of type 2 diabetes mellitus part 2—Addressing the incretin defect in clinical setting in 2013. J Diabetes. 2013 Mar 14. [Epub ahead of print] Handelsman Y, Mechanick JI, Blonde L, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract. 2011;17 (suppl 2):1-53. Johnson AM, Olefsky JM. The origins and drivers of insulin resistance. Cell. 2013;152:673-684. Lane WS, Weinrib SL, Rappaport JM, et al. The effect of long-term use of U-500 Insulin via continuous subcutaneous infusion on durability of glycemic control and weight in obese, insulin-resistant patients with type 2 diabetes. Endocr Pract. 2013;19:196-201. Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient—2013 update: Cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring). 2013;21 (suppl 1):S1-S27.

Ovalle F. Clinical approach to the patient with diabetes mellitus and very high insulin requirements. Diabetes Res Clin Pract. 2010;90:231-242. Reutrakul S, Wroblewski K, Brown RL. Clinical use of U-500 regular insulin: review and meta-analysis. J Diabetes Sci Technol. 2012;6:412-420. Taylor JR, Dietrich E, Powell JG. New and emerging pharmacologic therapies for type 2 diabetes, dyslipidemia, and obesity. Clin Ther. 2013;35:A3-A17. Wing RR, Lang W, Wadden TA, et al. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011;34:1481-1486.