Insulin has been used as a standard treatment for patients with diabetes for almost 100 years. Over time, advances in insulin development have improved its pharmacologic properties. Most recently, the US Food and Drug Administration approved a novel, follow-on basal insulin agent, with more expected to be commercially available in the near future. With the imminent availability of follow-on basal insulin agents, clinicians need to be aware of the potential benefits and concerns in order to facilitate informed decision making and to provide the best possible advice and guidance to their patients with diabetes. This program will review how follow-on insulin products are developed, manufactured, and receive regulatory approval; evaluate clinical trial data for new and emerging follow-on basal insulin agents; and provide practical information and guidance on how they may be incorporated into clinical practice. While it is unknown how follow-on basal insulins will affect patient outcomes, they have the potential to increase access to treatment among patients with diabetes and reduce healthcare costs.
This activity has been designed to meet the educational needs of health care professionals involved in the diagnosis, treatment, or management of patients with diabetes.
Upon completion of this activity, participants will be better able to do the following:
- Identify barriers to the initiation of basal insulin and strategies to remedy patient and physician misperceptions
- Define the terms generic, follow-on, and biosimilar with respect to the regulatory approval of new therapies for patient with diabetes
- Restate the efficacy, safety, and tolerability profile of novel follow-on basal insulin products in patients with diabetes
- Apply principles related to the initiation and titration of follow-on basal insulin to manage hyperglycemia in patients with T2DM
Steven V. Edelman, MD
Professor of Medicine
University of California San Diego
Veterans Affairs Medical Center
San Diego, California
Priscilla A. Hollander, MD, PhD
Baylor University Medical Center
Baylor Endocrine Center
Eugene E. Wright, Jr, MD
Department of Medicine and Department of Community and Family Medicine
Duke University School of Medicine
Durham, North Carolina
Disclosure of Conflicts of Interest
It is the policy of the Elsevier Office of Continuing Medical Education that all faculty, instructors, and planners disclose real or apparent conflicts of interest relating to the topics of this educational activity.
The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:
|Name of Faculty or Presenter||Relationship Identified With:|
|Steven V. Edelman, MD|
Consultant/Advisor: Eli Lilly and Company; Novo Nordisk A/S; Sanofi
Speakers’ Bureau: Eli Lilly and Company; Novo Nordisk A/S; Sanofi
Priscilla A. Hollander, MD, PhD
Consultant/Advisor: Eli Lilly and Company; Johnson & Johnson Services, Inc; Novo Nordisk A/S
Eugene E. Wright, Jr, MD
Consultant/Advisor: Abbott; Boehringer Ingelheim GmbH; Boehringer Ingelheim and Elli Lilly and Company Diabetes Alliance; Voluntis Connected Therapeutics
Speakers’ Bureau: Abbott; Boehringer Ingelheim GmbH; Boehringer Ingelheim and Elli Lilly and Company Diabetes Alliance; Voluntis Connected Therapeutics
Non-faculty: Deanna N. Schuly; Anne M. Sendaydiego, PharmD; Sandy Breslow; Alison Kemp; Bernard M. Abrams, MD; and Eileen Robinson, MSN, RN hereby state that neither they nor their spouse/life partner have any financial relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
This CME activity has been peer-reviewed by The American Journal of Medicine.
This activity has been supported by an independent educational grant from Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC.
Jointly provided by the Elsevier Office of Continuing Medical Education, Elsevier ANCC Accredited Provider Unit, and Global Directions in Medicine, Inc.
CME Credit (Physicians)
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 the Elsevier Office of Continuing Medical Education and Global Directions in Medicine, Inc. The Elsevier Office of Continuing Medical Education is accredited by the ACCME to provide continuing medical education for physicians.
The Elsevier Office of Continuing Medical Education designates this enduring activity for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CNE CREDIT (NURSES)
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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 the EOCME, Elsevier Accredited Provider Unit, and Global Directions in Medicine, Inc. The EOCME is accredited by the ACCME to provide continuing medical education for physicians. Elsevier’s Provider Unit is accredited by ANCC COA to provide continuing nursing education.
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Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The Elsevier Office of Continuing Medical Education, Global Directions in Medicine, Inc., Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC do not recommend the use of any agent outside of the labeled indications.
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 or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.