Clinical Updates in Type 2 Diabetes

Hilton Baltimore • Baltimore, Maryland This activity is jointly provided by Global Education Group and Integritas Communications.

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

A satellite symposium to be conducted in conjunction with APhA2016

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

FACULTY FACULTY

Scott R. Drab, PharmD, CDE, BC-ADM Associate Professor of Pharmacy and Therapeutics University of Pittsburgh School of Pharmacy Director, University Diabetes Care Associates Pittsburgh, Pennsylvania

Stuart T. Haines, PharmD, BCPS, BCACP, BC-ADM Professor and Vice Chair for Clinical Services Department of Pharmacy Practice and Science University of Maryland School of Pharmacy Baltimore, Maryland

Joshua J. Neumiller, PharmD, CDE, FASCP Vice Chair and Associate Professor Department of Pharmacotherapy Director of Experiential Services Editor-in-Chief, Diabetes Spectrum Washington State University College of Pharmacy Spokane, Washington

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TARGET AUDIENCE The educational design of this activity addresses the needs of pharmacists involved in the ongoing management of patients with type 2 diabetes mellitus (T2DM).

PREAMBLE

STATEMENT of NEED/ PROGRAM OVERVIEW Diabetes disorders afflict an estimated 28.9 million adult Americans, 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 are treated with insulin.3 The number of available insulin formulations has increased in the last few years, including trials with newer basal insulin with lower risks for hypoglycemia.4,5 Increasingly, pharmacists are being called to help manage the rising flood of patients with T2DM.6 Studies have demonstrated the positive effects of pharmacist-directed medical management on glycemic control and treatment adherence.7 This Interactive Exchange™ program has been designed to convey the latest clinical study data on insulin therapy to pharmacy clinicians, along with efficient and actionable guidance on insulin-based management of T2DM.

REFERENCES 1. Centers for Disease Control and Prevention. 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. Diabetes Care.

2013;36(8):2271-2279.

3. American Diabetes Association. Standards of medical care in diabetes--2016. Diabetes Care.

2016;39(suppl 1):S1-S104.

4. Rodbard HW, Cariou B, Zinman B, et al. Diabetes Obes Metab. 2014;16(9):869-872.

5. Riddle MC, Yki-Jarvinen H, Bolli GB, et al. Diabetes Obes Metab. 2015;17(9):835-842.

6. Watson LL, Bluml BM. J Am Pharm Assoc (2003). 2014;54(5):538-541.

7. Skinner JS, Poe B, Hopper R, Boyer A, Wilkins CH. Diabetes Educ. 2015;41(4):459-465.

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EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Discuss the evolution of insulin replacement therapy, including relationships with underlying T2DM disease mechanisms and the latest medication options • Compare the clinical profiles of formulations of basal insulins in the treatment of T2DM • Identify opportunities to modify insulin-based treatment regimens for T2DM based on guideline recommendations for patient-centered care, comprehensive treatment goals, and potential safety risks

PREAMBLE

• Communicate with patients with T2DM to reduce treatment-related risks (eg, hypoglycemia) and improve adherence to the therapeutic plan

PROGRAM AGENDA 6:30

am

– 6:35

am Welcome,

Introductions, and Preactivity Questionnaire

6:35

am

– 6:40

am

Disease Management Primer

6:40

am

– 7:25

am

Case Discussions on Insulin-Based Management

7:25

am

– 7:45

am Choose-a-Case™:

7:45

am

– 8:00

am Postactivity

Addressing Challenges in T2DM

Questionnaire and Question-and-Answer Session

PHARMACIST ACCREDITATION STATEMENT Global Education Group is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

CREDIT DESIGNATION Global Education Group designates this continuing education activity for 1.5 contact hour(s) (0.15 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number 0530-9999-15-211-L01-P) This is a knowledge-based activity.

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GLOBAL CONTACT INFORMATION For information about the accreditation of this program, please contact Global at 303-395-1782 or inquire@globaleducationgroup.com.

INSTRUCTIONS to RECEIVE CREDIT

PREAMBLE

In order to receive credit for this activity, the attendee must participate in the symposium and complete an evaluation form.

FEE INFORMATION & REFUND/ CANCELLATION POLICY There is no fee for this educational activity.

DISCLOSURE of CONFLICTS of INTEREST Global Education Group (Global) requires instructors, planners, managers and other individuals and their spouses/life partners who are in a position to control the content of this 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 are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Scott R. Drab, PharmD, CDE, BC-ADM Consultant: Novo Nordisk and sanofi-aventis U.S. LLC Stuart T. Haines, PharmD, BCPS, BCACP, BC-ADM Nothing to disclose Joshua J. Neumiller, PharmD, CDE, FASCP Consultant: sanofi-aventis U.S. LLC; Grant Research Support: AstraZeneca, Johnson & Johnson, Merck & Co., Inc., and Novo Nordisk; Speakers Bureau: Novo Nordisk

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The planners and managers reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Amanda Glazar, PhD

Nothing to disclose

Andrea Funk

Nothing to disclose

Laura Gilsdorf

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Global Education Group (Global) and Integritas do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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PREAMBLE

DISCLOSURE of UNLABELED USE

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GUIDELINES »» Standards of medical care in diabetes—2016.

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.

2016;39(suppl 1):S1–S112. http://care.diabetesjournals.org/site/misc/2016-Standards-of-Care.pdf

»» 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, lipids, 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. https://www.aace.com/files/dm-guidelines-ccp.pdf

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.

2016;22:84–113. https://www.aace.com/publications/algorithm

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RESOURCE CENTER

»» AACE/ACE comprehensive diabetes management algorithm 2016.

PATIENT RESOURCES »» Diabetes HealthSense This National Diabetes Education Program website provides easy access to resources for helping 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/

»» Decision Aids for T2DM To facilitate shared decision making, these examples of medication choice decision aids from the Mayo Clinic are organized into 7 issues that may be of interest to patients with T2DM. A video demonstrating the use of these cards can be found at: https://www.youtube.com/ watch?v=SYTPqceFgSw. http://shareddecisions.mayoclinic.org/files/2011/08/ Diabetes-brochure.pdf

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

Cahn A, et al. Lancet Diabetes Endocrinol. 2015;3(8):638-652. http://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.

RESOURCE CENTER

http://diabetes.diabetesjournals.org/content/58/4/773.full.pdf+html

»» 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, et al. Lancet. 2014;384(9961):2228-2234. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61335-0/abstract

»» Minimizing hypoglycemia in diabetes.

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

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»» 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, et al. Diabetes Care. 2015;38(1):140-149. http://care.diabetesjournals.org/content/38/1/140.full.pdf+html

»» 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. http://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. http://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, et al. Diabetes Obes Metab. 2013;15(2):175-184 http://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, et al. Diabetes Obes Metab. 2015;17(9):859-867. http://onlinelibrary.wiley.com/doi/10.1111/dom.12485/epdf

RESOURCE CENTER

»» Benefits of combination of insulin degludec and liraglutide are independent of baseline glycated haemoglobin level and duration of type 2 diabetes.

Rodbard HW, et al. Diabetes Obes Metab. 2016;18(1):40-48. http://onlinelibrary.wiley.com/doi/10.1111/dom.12574/epdf

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www.EXCHANGECME.com/APhA16

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