Hitting the Target in Type 2 Diabetes

This activity is sponsored by the American Osteopathic Association (AOA) and Integritas Communications.

This activity is supported by an educational grant from Novo Nordisk.

CME/MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

HITTING THE TARGET IN TYPE 2 DIABETES

Evolving Approaches to Insulin-Based Therapy

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FACULTY

JAVIER Morales, MD Vice President Principal Trials Investigator Advanced Internal Medicine Group, PC New Hyde Park, New York

Dr. Morales is in private practice with the Advanced Internal Medicine Group in New Hyde Park, NY. After having graduated from UMDNJ-NJ Medical School, his medical training included residencies at Memorial Sloan-Kettering Cancer Center and North Shore University Hospital where he served as Chief Medical Resident. He serves on multiple committees at St. Francis Hospital in Roslyn, NY, and, in addition to having published several times, he has served as principal investigator for several different studies and clinical trials.

He is active in the educational sector having presented at many Pri-Med symposia. He also serves as clinical instructor for several nurse practitioner programs and physician assistant programs, in addition to the internal medicine residency program at North Shore University Hospital and Winthrop University Hospital. Dr. Morales is an avid musician and percussionist, and is fluent in Spanish, Italian, and Portuguese. He is a member of the American Medical Association, American College of Physicians, American Society of Clinical Pathologists, National Hispanic Medical Association, Nassau County Medical Society, American Academy of Family Physicians, American Association of Clinical Endocrinologists, and is a fellow of the Interamerican College of Physicians and Surgeons.

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TARGET AUDIENCE This educational activity is intended to update osteopathic physicians on the latest approaches to insulin-based therapy for type 2 diabetes mellitus (T2DM).

STATEMENT of NEED and PROGRAM OVERVIEW Diabetes disorders afflict an estimated 28.9 million adult Americans (12.3% of the population), while another 86 million adults have prediabetes.1 Alarmingly, the prevalence of T2DM is projected to increase in the United States as obesity rates rise and higher-risk age and ethnic groups continue to expand.1 Given the numerous medical, psychosocial, and educational needs of people with T2DM, clinicians can struggle to help patients achieve recommended goals for glycemic control and other clinical parameters.2 The lack of a universally applicable treatment algorithm complicates the intensification of therapy. While management usually commences with metformin, the vast majority of patients with T2DM will eventually need more than 1 antihyperglycemic drug, and most eventually will be treated with insulin.3 A number of clinical studies examining insulin-based treatment have been completed in the past few years, including trials demonstrating long-term efficacy and safety or examining newer basal insulin with lower risks for hypoglycemia.4-6 As one of the fastest growing segments of health care providers, osteopathic physicians are increasingly called to manage the ongoing flood of patients with T2DM. The need to proactively address patient-specific needs in T2DM management is built into the core tenets of osteopathic medicine: 1) the person is a unit of body, mind, and spirit; 2) the body is capable of self-regulation, self-healing, and health maintenance; 3) structure and function are reciprocally interrelated; and 4) rational treatment is based on an understanding of these basic principles.7 This focused Interactive Professor™ program has been designed to convey the latest clinical study data on insulin therapy to osteopathic physicians, along with efficient and actionable guidance on insulin-based management of T2DM.

REFERENCES 1. CDC. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014.

2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf.

2. Stark Casagrande S, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010. Diabetes Care. 2013;36(8):2271-2279.

3. American Diabetes Association. Standards of medical care in diabetes—2015. Diabetes Care.

2015;36(suppl 1):S1-S94.

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4. Frederich R, McNeill R, Berglind N, Fleming D, Chen R. The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetol Metab Synd. 2012;4(1):36.

5. Rodbard HW, Cariou B, Zinman B, et al. Health status and hypoglycaemia with insulin degludec versus insulin glargine: a 2-year trial in insulin-naive patients with type 2 diabetes. Diabetes Obes Metab.

2014;16(9):869-872.

6. Riddle MC, Yki-Jarvinen H, Bolli GB, et al. One year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/mL compared with 100 U/mL in people with type 2 diabetes using basal + meal-time insulin (EDITION 1 12-month randomized trial including 6-month extension). Diabetes Obes Metab. 2015;17(9):835-842.

7. Shubrook JH, Jr, Johnson AW. An osteopathic approach to type 2 diabetes mellitus. J Am Osteopath Assoc. 2011;111(9):531-537.

EDUCATIONAL OBJECTIVES Upon completion of this activity, participants will be better prepared to: • Identify patient-centered glycemic targets for T2DM that decrease risks of long-term morbidity and mortality • Compare the clinical profiles of current and emerging basal insulin analogs, including combinations with GLP-1 receptor agonists, for the treatment of T2DM • Tailor insulin-based regimens for T2DM to achieve individualized treatment goals, control fasting and postprandial hyperglycemia, and minimize treatment-related risks

FACULTY FINANCIAL DISCLOSURE STATEMENTS The presenting faculty reported the following: Javier Morales, MD, is a consultant for Novo Nordisk; Eli Lilly and Company; Janssen Pharmaceuticals, Inc.; and Bristol Myers Squibb. He is also a member of the speakers’ bureaus of Novo Nordisk and Eli Lilly and Company.

ACCREDITATION The American Osteopathic Association Council on Continuing Medical Education designates this educational activity, in accordance with the AOA Accreditation Requirements and Policies, as 0.5 AOA Category 1-B credit.

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HITTING THE TARGET IN TYPE 2 DIABETES

Evolving Approaches to Insulin-Based Therapy

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Evolving Approaches to Insulin-Based Therapy

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GUIDELINES Standards of medical care in diabetes—2015.

The ADA’s Standards of Care provide clinicians, patients, researchers, payers, and other interested individuals with the components of good diabetes management, general treatment goals, and tools to evaluate the quality of care. Importantly, these recommendations should be adjusted based on individual preferences, comorbidities, and other patient-related factors.

American Diabetes Association. Diabetes Care. 2015;38(suppl 1):S1-S94. »» care.diabetesjournals.org/content/38/Supplement–1

American Association of Clinical Endocrinologists and American College of Endocrinology—Clinical practice guidelines for developing a diabetes mellitus comprehensive care plan—2015.

These 2015 clinical practice guidelines provide a practical guide for comprehensive care that incorporates an integrated consideration of microvascular and macrovascular risk—including such cardiovascular risk factors as lipids, hypertension, and coagulation—rather than focusing only on glycemic control.

The guidelines emphasize individualized targets for weight loss, glucose, lipid, and blood pressure, and contain updated information on hypertension management, nephropathy management, hypoglycemia, and antihyperglycemic therapy.

Handelsman Y, Bloomgarden ZT, Grunberger G, et al. Endocr Pract.

2015;21(suppl 1):1-87. »» www.aace.com/files/dm-guidelines-ccp.pdf

AACE/ACE comprehensive diabetes management algorithm 2015.

This algorithm from the AACE addresses evaluating the whole patient, potential risks and complications, and evidence-based treatment approaches for diabetes. The document contains sections on obesity, prediabetes, hyperglycemia therapy (lifestyle modifications, pharmacotherapy, and insulin), hypertension management, hyperlipidemia treatment, and other risk-reduction strategies.

Garber AJ, Abrahamson MJ, Barzilay JI, et al. Endocr Pract.

2015;21(4):438-447. »» www.aace.com/files/aace – algorithm.pdf

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PATIENT RESOURCE Diabetes HealthSense Provides easy access to resources to help patients live well and meet their goals—whether they have diabetes or are at risk for the disease. »» http://ndep.nih.gov/resources/diabetes-healthsense/

SUGGESTED READINGS New forms of insulin and insulin therapies for the treatment of type 2 diabetes.

Cahn A, Miccoli R, Dardano A, Del Prato S. Lancet Diabetes Endocrinol. 2015;3(8):638-652. »» www.thelancet.com/pdfs/journals/landia/PIIS2213-8587(15)00097-2.pdf

From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus.

Defronzo RA. Diabetes. 2009;58(4):773-795. »» www.ncbi.nlm.nih.gov/pmc/articles/PMC2661582/pdf/zdb773.pdf

Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis.

Eng C, Kramer CK, Zinman B, Retnakaran R. Lancet. 2014;384(9961):2228-2234. »» www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61335-0/abstract

Minimizing hypoglycemia in diabetes.

International Hypoglycemia Study Group. Diabetes Care. 2015;38(8):1583-1591. »» care.diabetesjournals.org/content/38/8/1583.full

Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes.

Inzucchi SE, Bergenstal RM, Buse JB, et al. Diabetes Care. 2015;38(1):140-149. »» care.diabetesjournals.org/content/38/1/140.full.pdf+html

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Minimizing hypoglycemia and weight gain with intensive glucose control: potential benefits of a new combination therapy (IDegLira).

Morales J, Merker L. Adv Ther. 2015;32(5):391-403. »» www.ncbi.nlm.nih.gov/pmc/articles/PMC4449377/pdf/12325 –2015 – Article –208.pdf

Basal insulin and cardiovascular and other outcomes in dysglycemia.

ORIGIN Trial Investigators. N Engl J Med. 2012;367(4):319-328. »» www.nejm.org/doi/pdf/10.1056/NEJMoa1203858

Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials Ratner RE, Gough SC, Mathieu C, et al. Diabetes Obes Metab. 2013;15(2):175-184. »» www.ncbi.nlm.nih.gov/pmc/articles/PMC3752969/pdf/dom0015-0175.pdf

Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes Ritzel R, Roussel R, Bolli GB, et al. Diabetes Obes Metab. 2015;17(9):859-867. »» onlinelibrary.wiley.com/doi/10.1111/dom.12485/epdf

Identifying and meeting the challenges of insulin therapy in type 2 diabetes.

Sorli C, Heile MK. J Multidiscip Healthc. 2014;7:267-282. »» www.ncbi.nlm.nih.gov/pmc/articles/PMC4086769/pdf/jmdh-7-267.pdf

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NOTES

HITTING THE TARGET IN TYPE 2 DIABETES

Evolving Approaches to Insulin-Based Therapy

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