Incorporating New Therapies into Antihyperglycemic Regimens with Mark Stolar, MD

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Incorporating New Therapies into Antihyperglycemic Regimens with Mark Stolar, MD

Mark Stolar, MD

Release Date: October 16, 2015

Expiration Date: October 15, 2016 (THIS ACTIVITY IS NO LONGER AVAILABLE FOR CREDIT)

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ACTIVITY DESCRIPTION

In less than 45 minutes, you can watch this on-demand, case-based activity from proceedings of a CME/CE symposium at the American Diabetes Association’s 75^th Scientific Sessions. Learn about:

Recently approved therapies for the treatment of diabetes, including SGLT-2 inhibitors and incretin therapies
Identifying a diabetes management regimen for Max, a patient with diabetes and multiple comorbidities

LEARNING OBJECTIVES

Upon completion of this activity, the participant should be able to:

Summarize the efficacy and safety data for therapies that were recently approved for the treatment of diabetes, including SGLT-2 inhibitors and incretin therapies
Select diabetes management regimens that maximize glycemic control while minimizing adverse effects and considering patient comorbidities, preferences, and concerns

FACULTY

Mark Stolar, MD

Associate Professor of Clinical Medicine

Northwestern University Feinberg School of Medicine

Chicago, IL

FACULTY BIOGRAPHY

Mark Stolar, MD, is Associate Professor of Clinical Medicine, General Internal Medicine, and Geriatrics at Northwestern University Feinberg School of Medicine in Chicago, Illinois. Dr Stolar received his medical degree from the University of Illinois, Chicago. He completed his fellowship in endocrinology at the Northwestern University Medical School and his residency in internal medicine at Lutheran General Hospital, Park Ridge, Illinois. Dr Stolar is board certified in endocrinology, diabetes and metabolism, and internal medicine.

Dr Stolar’s academic interests include diabetes, lipid disorders, and thyroid disease. A highly regarded speaker, he is actively involved in physician education in the areas of diabetes and cardiovascular disease, and has both written and presented in the United States and internationally in these areas. He is currently President of the Endocrine Fellows Foundation and is actively involved in enhancing career opportunities for trainees in endocrinology.

DISCLOSURE STATEMENTS

In accordance with the Accreditation Council for Continuing Medical Education (ACCME), Dannemiller requires that any person who is in a position to control the content of a CME activity must disclose all relevant financial relationships they have with a commercial interest.

The following faculty member has disclosures to be made:

Mark Stolar, MD

Speakers Bureau: AstraZeneca LP; Takeda Pharmaceuticals U.S.A., Inc

Consultant/Advisory Board: AstraZeneca LP; sanofi-aventis U.S. LLC; Takeda Pharmaceuticals U.S.A., Inc

Dr Stolar does not discuss information related to non–FDA-approved or investigational use of a product/device.

The following have no financial relationships with commercial interests to disclose:

INDEPENDENT REVIEWER

In order to resolve conflict of interest, presentations of this activity were peer reviewed by an independent reviewer. The reviewer has no relationship with a commercial interest. The resulting certified activity was found to provide educational content that is current, evidence-based, and commercially balanced.

Bernard Abrams, MD, Clinical Content Reviewer, has no financial relationships with commercial interests.

EDUCATIONAL PLANNING COMMITTEE

Dannemiller

Gordon Ringler, Dannemiller Director of Medical Education, has no financial relationships with commercial interests.

Spire Learning

Lauren Waters and Elysa Ripa, Program Directors; Jaime Symowicz, PhD, Senior Clinical Director; and Lisa Conklin, Group Director, Grants and Education, have no financial relationships with commercial interests.

DISCLAIMER

The content and views presented in this educational activity are those of the presenter and do not necessarily reflect those of Dannemiller, Spire Learning, Boehringer Ingelheim Pharmaceuticals, Inc. or Lilly USA, LLC. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.

OFF-LABEL STATEMENT

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The opinions expressed in the educational activity are those of the faculty. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Further, participants should appraise the information presented critically and are encouraged to consult appropriate resources for any product or device mentioned in this program.

LEVELS OF EVIDENCE

Level of Evidence	Description
A	Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered, including Evidence from a well-conducted multicenter trial Evidence from a meta-analysis that incorporated quality ratings in the analysis Compelling nonexperimental evidence; i.e., “all or none” rule developed by the Centre for Evidence-Based Medicine at the University of Oxford Supportive evidence from well-conducted randomized controlled trials that are adequately powered, including Evidence from a well-conducted trial at one or more institutions Evidence from a meta-analysis that incorporated quality ratings in the analysis
B	Supportive evidence from well-conducted cohort studies Evidence from a well-conducted prospective cohort study or registry Evidence from a well-conducted meta-analysis of cohort studies Supportive evidence from a well-conducted case-control study
C	Supportive evidence from poorly controlled or uncontrolled studies Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results Evidence from observational studies with high potential for bias (such as case series with comparison with historical controls) Evidence from case series or case reports Conflicting evidence with the weight of evidence supporting the recommendation
E	Expert consensus or clinical experience

Source: ADA evidence-grading system for “Standards of Medical Care” in Diabetes Care. 2015;38(Suppl 1):S1-S93.

TARGET AUDIENCE

This activity is designed for endocrinologists, primary care physicians (PCPs), physician assistants (PAs), nurse practitioners (NPs), and nurses with an interest in the management of Type 2 diabetes (T2DM).

ACCREDITATION

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Dannemiller and Spire Learning. Dannemiller is accredited by the ACCME to provide continuing medical education for physicians.

Dannemiller designates this enduring activity for a maximum of .75 AMA PRA Category 1 Credits^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credits^TM from organizations accredited by ACCME.

Dannemiller is approved as a provider of nurse practitioner continuing education by the American Association of Nurse Practitioners: AANP Provider Number 090419. This program was planned in accordance with AANP CE Standards and Policies and AANP Commercial Support Standards.It provides .75 credits of continuing education (which includes 0.25 hours of pharmacology).

METHOD OF PARTICIPATION

This activity has no fee and should take approximately 45 minutes to complete. Participants should first read the objectives and other introductory CME information, then complete the pre-assessment and participate in the online case activity. To receive credit for this activity, participants must complete the post-assessment with a passing score of 70% and then complete the evaluation. This credit is valid through October 15, 2016. No credit will be given after this date. In the event you have questions about this activity or are unable to print the certificate, please e-mail Lauren Waters at lwaters@spirelearning.com, and a certificate will be e-mailed within 2 weeks.

This educational activity is jointly provided by Dannemiller and Spire Learning.

This activity is supported by an independent educational grant from Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC.

References for Incorporating New Therapies into Antihyperglycemic Regimens with Mark Stolar, MD

Sources/References:

Abdul-Ghani MA, et al. Inhibition of renal glucose reabsorption: a novel strategy for achieving glucose control in type 2 diabetes mellitus. Endocr Pract. 2008;14:782-790.

Ahrén B, et al. HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin. Diabetes Care. 2014;37:2141-2148.

Berg JK, et al. Effects of exenatide twice daily versus sitagliptin on 24-h glucose, glucoregulatory and hormonal measures: a randomized, double-blind, crossover study. Diabetes Obes Metab. 2011;13:982-989.

Bergenstal RM, et al. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet Diabetes Endocrinol. 2010;376:431-439.

Bethel MA, et al. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab. 2015;17:395-402.

Blevins T, et al. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011;96:1301-1310.

Buse JB, et al. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet Diabetes Endocrinol. 2013;381:117-124.

Buse JB, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet Diabetes Endocrinol. 2009;374:39-47.

CDC. National Diabetes Statistics Report, 2014. www.cdc.gov.

Cefalu W, et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet Diabetes Endocrinol. 2013;382:941-950.

Cefalu WT. Evolving treatment strategies for the management of type 2 diabetes. Am J Med. 2012;343:21-26.

Chico A, et al. The continuous glucose monitoring system is useful for detecting unrecognized hypoglycemias in patients with type 1 and type 2 diabetes but is not better than frequent capillary glucose measurements for improving metabolic control. Diabetes Care. 2003;26:1153-1157.

ClinicalTrials.gov. Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide) (ELIXA). NCT 01147250.

ClinicalTrials.gov. Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus. NCT 01144338.

ClinicalTrials.gov. Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results - A Long Term Evaluation (LEADER^®). NCT 01179048.

ClinicalTrials.gov. Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND). NCT 01394952.

Davies M, et al. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009;11:1153-1162.

Davies M, et al. Once-weekly exenatide versus once- or twice-daily insulin detemir: randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureas. Diabetes Care. 2013;36:1368-1376.

Deacon C, et al. Potential cardiovascular effects of incretin-based therapies. Expert Rev Cardiovasc Ther. 2012;10:337-351.

DeFronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58:773-795.

Del Prato S, et al. Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. Diabetes Obes Metab. 2015;17:581-590.

Del Prato S, et al. Megatrials in type 2 diabetes. From excitement to frustration? Diabetologia. 2009;52:1219-1226.

Diamant M, et al. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet Diabetes Endocrinol. 2010;375:2234-2243.

Drucker DJ. Glucagon-like peptides. Diabetes. 1998;47:159-169.

Duckworth W, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009;360:129-139.

Dungan K, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial.Lancet Diabetes Endocrinol. 2014; 384:1349-1357.

Ferrannini E, et al. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010;33:2217-2224.

Ferrannini E, et al. SGLT2 inhibition in diabetes mellitus: rationale and clinical prospects. Nat Rev Endocrinol. 2012;8:495-502.

Flint A, et al. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest. 1998;101:515-520.

Garber A, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet Diabetes Endocrinol. 2009;373:473-481.

Giorgino F, et al. Efficacy and safety of once-weekly dulaglutide vs. insulin glargine in combination with metformin and glimepiride in type 2 diabetes patients (AWARD-2). Diabetes. 2014;63(suppl 1):Abstract 87.

Häring HU, et al. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013;36:3396-3404.<

Heine R, et al. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2005;143:559-569.

Inzucchi SE, et al. 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. Diabetes Care. 2015;38:140-149.

Jabbour S, et al. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37:740-750.

Kruger DF, et al. Understanding GLP-1 analogs and enhancing patients success. Diabetes Educ. 2010;36(suppl 3):44S-72S.

Larsson H, et al. Glucagon-like peptide-1 reduces hepatic glucose production indirectly through insulin and glucagon in humans. Acta Physiol Scand. 1997;160:413-422.

Marx N, et al. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA^®). Diab Vasc Dis Res. 2015;12:164-174.

Mather A, et al. Glucose handling by the kidney. Kidney Int Suppl. 2011;120:S1-S6.

Mattaei S, et al. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015;38:365-372.

Meier JJ, et al. GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2012;8:728-742.

Moretto T, et al. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2008;30:1448-1460.

Nauck M, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011;34:2015-2022.

Nauck M, et al. HARMONY 2 Wk 52 Results: Albiglutide Monotherapy in Drug Naïve Patients With Type 2 Diabetes Mellitus.ADA 73rd Scientific Sessions. 2013. Abstract 55-LB. Nauck MA, et al. Effects of subcutaneous glucagon-like peptide 1 (GLP-1 [7-36 amide]) in patients with NIDDM. Diabetologia. 1996;39:1546-1553.

Neal B, et al. Efficacy and safety of canagliflozin, an inhibitor of sodium-glucose cotransporter 2, when used in conjunction with insulin therapy in patients with type 2 diabetes. Diabetes Care. 2015;38:403-411.

Pratley R, et al. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014;2:289-297.

Pratley R, et al. HARMONY 4: 52-Wk Efficacy of Albiglutide (Albi) vs. Insulin Glargine (Glar) in Patients (pts) With T2D. ADA 73rd Scientific Sessions. 2013. Abstract 54-LB.

Pratley RE, et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet Diabetes Endocrinol. 2010;375:1447-1456.

Ridderstråle M, et al. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial.Lancet Diabetes Endocrinol. 2014;2:691-700.

Roden M, et al. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013;1:208-219.

Rosenstock J, et al. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014;37:1815-1823.

Russell-Jones D, et al. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012;35:252-258.

Russell-Jones D, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009;52:2046-2055.

Schernthaner K, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013;36:2508-2515.

Scirica BM, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369:1317-1326.

Seaquist ER, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36:1384-1395.

Singh S, et al. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med. 2013;173:534-539.

Stenlöf K, et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15:372-382.

UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet Diabetes Endocrinol. 1998;352:837-853.

Umpierrez G, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37:2168-2176.

Vasilakou D, et al. Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013;159:262-274.

Weber KK, et al. High frequency of unrecognized hypoglycaemias in patients with Type 2 diabetes is discovered by continuous glucose monitoring. Exp Clin Endocrinol Diabetes. 2007;115:491-494.

Wilding J, et al. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab. 2013;16:124-136.

Wysham C, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014;37:2159-2167.

Zannad F, et al. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet Diabetes Endocrinol. 2015;385:2067-2076.

Zick R, et al. Comparison of continuous blood glucose measurement with conventional documentation of hypoglycemia in patients with Type 2 diabetes on multiple daily insulin injection therapy. Diabetes Technol Ther. 2007;9:483-492.

Incorporating New Therapies into Antihyperglycemic Regimens click here.

Factors to Consider When Incorporating New Therapies Into a Patient’s Antihyperglycemic Regimen Resource Tool click here.

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.

http://care.diabetesjournals.org/content/38/1/140.full.pdf+html.

AACE/ACE Comprehensive Diabetes Management Algorithm 2015.

http://journals.aace.com/doi/pdf/10.4158/EP15693.CS.

American Diabetes Association Standards of Medical Care in Diabetes 2015.

link to: http://care.diabetesjournals.org/content/38/Supplement_1.toc.

Diabetes Self-management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics.

http://care.diabetesjournals.org/content/38/7/1372.full.pdf+html.