Type 2 diabetes in the US managed care setting: the burden of disease and rationale for an oral glucagon-like peptide-1 receptor agonist.

Diabetes affects an estimated 34 million US adults, with type 2 diabetes (T2D) accounting for 90% to 95% of cases. The downstream consequences of uncontrolled T2D are substantial, including an increased risk of microvascular complications (eg, renal impairment, retinopathy, and peripheral neuropathy), cardiovascular disease, impaired quality of life, and death. Overall, diabetes places a significant strain on the US health care system, with 7.8 million hospitalizations annually among patients with diabetes, and $237 billion in direct medical costs. Injectable glucagon-like peptide-1 receptor agonists (GLP-1RAs) have been available for T2D for over a decade, and are recommended, in particular, for patients with a compelling need to minimize hypoglycemia risk, curtail weight gain, or promote weight loss, and for patients with established cardiovascular disease. Despite being associated with high glucose-lowering efficacy, weight loss, and a low risk of hypoglycemia, injectable GLP-1RAs are relatively underutilized, and are associated with suboptimal adherence and persistence. These challenges may relate in part to the injectable route of administration, given that injection-related concerns have been linked with a failure to intensify T2D therapy in a timely manner (ie, therapeutic inertia), and are cited by patients as a barrier to initiating and persisting with injectable treatments. The approval of the first tablet formulation of a GLP-1RA for T2D, oral semaglutide, has the potential to address these challenges. In this context, we review the burden of T2D in the United States, the role of GLP-1RAs, the challenges of therapeutic inertia and poor adherence, and the rationale for an oral GLP-1RA, focusing on considerations for managed care.

Automated Insulin Delivery: Easy Enough to Use in Primary Care?

There are three automated insulin delivery devices on the U.S. market, two of which are currently approved by the U.S. Food and Drug Administration. These systems have already made a significant impact for the people who use them in improving diabetes outcomes, including glycemic control and hypoglycemia prevention. This article aims to help primary care and endocrinology providers better understand the components, differences, limitations, and potential fit of these systems into clinical practice.

Divergence in perceptions of diabetes control among patients with type 2 diabetes mellitus treated with basal insulin and health care professionals: results from the US Perceptions of Control (POC-US) study.

Background: Approximately 60% of the patients with type 2 diabetes mellitus (T2DM) on basal insulin have an HbA1c ≥7%. This analysis of the US Perceptions of Control (POC-US) study aimed to understand US patient and health care professional (HCP) views of diabetes "control," which may play a role in whether patients reduce their HbA1c or achieve HbA1c <7%. Methods: A cross-sectional, Web-based survey of 500 US HCPs (primary care physicians, endocrinologists, nurse practitioners/physician assistants) and 618 US adults with T2DM using basal insulin was conducted to assess perceptions, attitudes, and behaviors associated with T2DM management. The survey was developed from previous research examples and qualitative exploratory research and was pretested. Patients self-reported their most recent HbA1c level and confirmed this value with their HCP, if necessary. Results: Patients and HCPs differed on some definitions of "in control." HbA1c value was used most often by both populations, but more frequently by HCPs (91% vs 69%). Patients also often used behavioral criteria (eg, adherence to lifestyle changes and/or treatment regimens), and HCPs often used clinical criteria (eg, hypoglycemia). Most HCPs focused on the last 3 months to define control (67% vs 34% patients; P<0.05), whereas patients more frequently reported focusing on "the current moment" or "the past week." Patients were more likely to agree that controlling their condition is "completely the patients' responsibility" (patients, 67%; HCPs, 34%; P<0.05); HCPs were more likely to agree that they have "a responsibility to actively contribute to the control of their patients' T2DM" (90% vs 60%; P<0.05). Conclusion: US patients with T2DM have differing views from HCPs on key aspects of diabetes control and management and are less likely to consider HbA1c value as a criterion for determining control. Recognizing and addressing these differences may improve patient-HCP communication and may potentially improve patient outcomes.

Burden of Illness in Type 2 Diabetes Mellitus.

An estimated 30.2 million Americans have diabetes, and this number is expected to increase based on trends over recent decades and compounded by an aging U.S. POPULATION: As reviewed in this article, type 2 diabetes mellitus (T2DM) is associated with impaired health-related quality of life (HRQoL) and with a substantial socioeconomic burden. Compared with individuals without T2DM, those with T2DM have worse HRQoL, greater decrements in HRQoL over time, and possibly greater depressive symptomology. Diabetes-related complications and comorbidities (e.g., obesity and cardiovascular disease) are associated with worse HRQoL. Hypoglycemic episodes are associated with reduced HRQoL and greater levels of depression; they can also interfere with social and occupational activities. In turn, low HRQoL can be a driver for poor glycemic control. In 2012, the total estimated cost associated with diagnosed diabetes in the United States was $245 billion. Factors contributing to increased health care resource utilization and costs in patients with T2DM include medical comorbidities, diabetes-related complications, inadequate glycemic control, and hypoglycemic episodes. Readmission is a key driver of hospital-related costs and is more common among elderly patients with T2DM. Elderly patients with T2DM represent a particularly vulnerable population given that these patients may have varying degrees of physical and mental comorbidities that can increase their risk of hypoglycemia, falls, and depression. This review demonstrates that T2DM imposes a considerable burden on both the individual and society. Treatment strategies should consider the effects of treatment on HRQoL and on outcomes (e.g., complications and hypoglycemia) that affect both HRQoL and costs. Management strategies that maximize HRQoL while minimizing the risk of hypoglycemia and other treatment-related complications are particularly critical in the elderly. DISCLOSURES: This supplement was funded by Novo Nordisk. Cannon reports speaker fees and owns stock in Novo Nordisk. Handelsman reports research grants from Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Grifols, Janssen, Lexicon, Merck, Novo Nordisk, Regeneron, and Sanofi; speaker fees from Amarin, Amgen, AstraZeneca, Boehringer Ingelheim-Lilly, Janssen, Merck, Novo Nordisk, Regeneron, and Sanofi; and has served in advisory capacity to Amarin, Amgen, AstraZeneca, Boehringer Ingelheim, Eisai, Intarcia, Janssen, Lilly, Merck, Merck-Pfizer, Novo Nordisk, Regeneron, and Sanofi. Heile reports speaker fees from and has served as advisor to Novo Nordisk. Shannon reports consultant and speaker fees from Novo Nordisk and Boehringer Ingelheim-Lilly Alliance.

Cardiovascular Outcomes with Once-Weekly GLP-1 RAs: Clinical and Economic Implications.

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of atherosclerotic cardiovascular (ASCVD) disease, which is the largest contributor to the economic burden of diabetes. Minimization of disease morbidity through comprehensive management of ASCVD risk factors, including but not limited to hyperglycemia, is a key goal of T2DM therapy. Emerging evidence with some glucagon-like peptide-1 receptor agonists (GLP-1 RAs) points to beneficial effects across a range of atherosclerotic risk factors and possible improvement of some cardiovascular outcomes independent of these effects. Given these benefits, there has been substantial interest in evaluating the cardiovascular safety of GLP-1 RAs as well as their potential to reduce the risk of major adverse cardiac events (MACE). Following the superior clinical outcome with the once-daily GLP-1 RA liraglutide (Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results [LEADER]), this review examines and summarizes the effects of once-weekly GLP-1 RAs, including exenatide extended release (ER), dulaglutide, and semaglutide, on reducing cardiovascular events in patients with T2DM. A phase 3 cardiovascular outcomes trial (EXSCEL) of exenatide ER found no significant difference between exenatide ER and placebo in reducing MACE in patients with T2DM. In a phase 3 premarketing trial in T2DM patients at high risk of cardiovascular disease (SUSTAIN-6), semaglutide significantly reduced the risks of MACE and non-fatal stroke compared with placebo. A phase 3 study (REWIND) is underway to evaluate the effects of dulaglutide on MACE. Considering the substantial costs of cardiovascular disease in patients with T2DM, it will be of interest to assess the impact of treatment with once-weekly GLP-1 RAs on cardiovascular disease-related costs among patients with T2DM. DISCLOSURES: This supplement was funded by Novo Nordisk. Heile reports speaker fees from and has served as advisor to Novo Nordisk. Billings reports personal fees from Dexcom, Novo Nordisk, and Sanofi. Cannon reports speaker fees and owns stock in Novo Nordisk. Handelsman reports research grants from Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Grifols, Janssen, Lexicon, Merck, Novo Nordisk, Regeneron, and Sanofi; speaker fees from Amarin, Amgen, AstraZeneca, Boehringer Ingelheim-Lilly, Janssen, Merck, Novo Nordisk, Regeneron, and Sanofi; and has served in advisory capacity to Amarin, Amgen, AstraZeneca, Boehringer Ingelheim, Eisai, Intarcia, Janssen, Lilly, Merck, Merck-Pfizer, Novo Nordisk, Regeneron, and Sanofi. Shannon reports consultant and speaker fees from Novo Nordisk and Boehringer Ingelheim-Lilly Alliance. Wyne has nothing to disclose.

Health-Related Quality of Life Assessments with Once-Weekly Glucagon-Like Peptide-1 Receptor Agonists in Type 2 Diabetes Mellitus.

Type 2 diabetes (T2DM) is associated with significant impairment in health-related quality of life (HRQoL). A patient-centered collaborative approach is recommended to optimize clinical outcomes, including HRQoL, in this patient population. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) provide effective glycemic control and have demonstrated beneficial effects on HRQoL and treatment satisfaction. Available once-weekly GLP-1 RAs may offer enhanced convenience compared with daily GLP-1 RAs and include exenatide extended-release (ER), dulaglutide, and semaglutide. This article reviews the impact of once-weekly GLP-1 RAs on HRQoL and treatment satisfaction in patients with T2DM. Compared with oral antihyperglycemic drugs, insulin, and daily GLP-1 RAs, once-weekly GLP-1 RAs offer benefits with regard to HRQoL and treatment satisfaction. These benefits appear to be largely mediated by relative drug effects on glycemic control, weight, and hypoglycemia. While there was not an overall class benefit of once-weekly GLP-1 RAs compared with daily GLP-1 RAs on HRQoL and treatment satisfaction, results suggested that once-weekly GLP-1 RAs may enhance certain elements of treatment satisfaction and increase willingness to continue treatment. In 2 studies comparing once-weekly GLP-1 RAs with each other, semaglutide produced significantly greater improvement in overall treatment satisfaction compared with exenatide ER but not dulaglutide. Once-weekly GLP-1 RAs represent an effective and convenient treatment option that may potentially increase treatment satisfaction and enhance adherence, contributing to improved health outcomes. DISCLOSURES: This supplement was funded by Novo Nordisk. Billings reports personal fees from Dexcom, Novo Nordisk, and Sanofi. Handelsman reports research grants from Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Grifols, Janssen, Lexicon, Merck, Novo Nordisk, Regeneron, and Sanofi; speaker fees from Amarin, Amgen, AstraZeneca, Boehringer Ingelheim-Lilly, Janssen, Merck, Novo Nordisk, Regeneron, and Sanofi; and has served in advisory capacity to Amarin, Amgen, AstraZeneca, Boehringer Ingelheim, Eisai, Intarcia, Janssen, Lilly, Merck, Merck-Pfizer, Novo Nordisk, Regeneron, and Sanofi. Heile reports speaker fees from and has served as advisor to Novo Nordisk. Schneider reports advisory board fees from Intarcia, Lilly, and Novo Nordisk. Wyne has nothing to disclose.

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

Type 2 diabetes mellitus (T2DM) is a chronic illness that requires clinical recognition and treatment of the dual pathophysiologic entities of altered glycemic control and insulin resistance to reduce the risk of long-term micro- and macrovascular complications. Although insulin is one of the most effective and widely used therapeutic options in the management of diabetes, it is used by less than one-half of patients for whom it is recommended. Clinician-, patient-, and health care system-related challenges present numerous obstacles to insulin use in T2DM. Clinicians must remain informed about new insulin products, emerging technologies, and treatment options that have the potential to improve adherence to insulin therapy while optimizing glycemic control and mitigating the risks of therapy. Patient-related challenges may be overcome by actively listening to the patient's fears and concerns regarding insulin therapy and by educating patients about the importance, rationale, and evolving role of insulin in individualized self-treatment regimens. Enlisting the services of Certified Diabetes Educators and office personnel can help in addressing patient-related challenges. Self-management of diabetes requires improved patient awareness regarding the importance of lifestyle modifications, self-monitoring, and/or continuous glucose monitoring, improved methods of insulin delivery (eg, insulin pens), and the enhanced convenience and safety provided by insulin analogs. Health care system-related challenges may be improved through control of the rising cost of insulin therapy while making it available to patients. To increase the success rate of treatment of T2DM, the 2012 position statement from the American Diabetes Association and the European Association for the Study of Diabetes focused on individualized patient care and provided clinicians with general treatment goals, implementation strategies, and tools to evaluate the quality of care.

Integrating advances in insulin into clinical practice: Effective utilization of insulin in patient management.

The management of a patient with type 2 diabetes mellitus (T2DM) is typically a long-term process characterized by evolving strategies to meet and maintain the patient's glycemic, cardiovascular, lifestyle, and other goals.