How Basal Insulin Analogs Have Changed Diabetes Care

Abstract

Diabetes Technology & TherapeuticsVol. 13, No. S1 Basal InsulinEditorialOpen AccessHow Basal Insulin Analogs Have Changed Diabetes CareSatish K. Garg and Emily G. MoserSatish K. GargBarbara Davis Center for Diabetes, University of Colorado Denver, Aurora, Colorado.Search for more papers by this author and Emily G. MoserSchool of Medicine, University of Colorado Denver, Aurora, Colorado.Search for more papers by this authorPublished Online:13 Jun 2011https://doi.org/10.1089/dia.2011.0072AboutSectionsPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail The most recent estimate in January 2011 is that 25.8 million, or 8.3%, of people in the United States have diabetes1 in addition to a global epidemic of diabetes especially in the Asian subcontinent.2 Now it is predicted that by the year 2030, there will be more than 439 million people with diabetes globally.2 It has been demonstrated that a significant decrease in hemoglobin A1c (A1c) as a result of better glycemic control can result in a reduction of both micro- and macrovascular complications associated with type 1 and type 2 diabetes.3–5 Despite reduced complications of the disease, recent healthcare cost estimates are likely to increase to $336 billion per annum by 2034 (from $218 billion annually).6,7 The development of basal insulin analogs has greatly impacted the management of diabetes.The first long-acting insulin, protamine insulin, was discovered in the 1930s. This discovery paved the way for the future of basal insulins, including neutral protamine Hagedorn (NPH) and zinc insulin (lente), both introduced in the 1950s.8 David Owens discusses at length the history of basal insulins and the progress and development leading to the currently used longer-acting insulin analogs.9Initiating a patient on insulin requires the provider to take several variables into consideration, including choosing the proper insulin for each patient and weighing the benefits and risk (especially of hypoglycemia) of each of the options. In addition, the clinician must determine the best combination of agents, including oral and injectables, that will allow the patient the best glycemic control without negatively impacting health and compliance. Frank Lavernia highlights the issues with premixed insulin and compares them with the basal/bolus options available when initiating insulin treatment in his article in this supplement:10 both options can achieve similar glucose control as measured by A1c levels, but with significantly higher insulin dose and an increased weight gain associated with more hypoglycemic events with premixed insulins.The use of basal insulin analogs varies markedly depending on whether the patient is diagnosed with type 1 or type 2 diabetes mellitus. As Geremia Bolli and co-workers discuss in this supplement, patients with type 1 diabetes are treated with multiple daily injections or continuous subcutaneous insulin infusion.11 Many studies have compared the two regimens with conflicting results.12,13 However, meta-analysis does favor insulin pump therapy with a significant reduction in A1c, insulin dose, and hypoglycemia with a possible increased risk of diabetic ketoacidosis.14 For patients with type 2 diabetes, it is safer to begin initial treatment with once-daily long-acting insulin combined with an oral diabetes medication(s) as opposed to beginning with twice daily premixed insulin and oral diabetes agents.15 Stephen Davis and colleagues explain the rationale of the use of basal insulins in type 2 diabetes in this supplement.16Frequency and risk of hypoglycemia are important factors to consider when comparing basal insulins. However, this comparison is difficult to study consistently, and most clinicians are interested in efficacy of the insulin on A1c. Thus, many studies do not focus on rates of hypoglycemia as a true end point and, instead, look at overall glycemic control.17 To increase compliance, every attempt must be made to reduce hypoglycemia with addition of any new therapy.Most patients with type 2 diabetes are initiated with basal insulin and bolus insulin is added with an analog insulin (glulisine, aspart, or lispro) when they are not achieving target glycemic control with basal insulin alone. However, the patients experience increased hypoglycemic episodes and weight gain when switching to two or three premixed insulin injections or adding a prandial insulin to their basal insulin.10,18 Another approach of transitioning patients into their basal–bolus regimen may be the “basal plus strategy” in an attempt to minimize the negative aspects of adding prandial insulin. “This approach considers the addition of increasing injections of prandial insulin, beginning with the meal that has the major impact on postprandial glucose values.”19 Javier Ampudia-Blasco and colleagues examine the use of this new strategy in this supplement.19It is important to consider the pharmacokinetic and pharmacodynamic properties of each insulin (insulin glargine, detemir, or, later, degludec). In a study conducted in 2000, it was determined that both NPH and ultralente insulins tend to peak, whereas insulin glargine was relatively peakless with a 24-h profile in the majority of the patients.20 Many studies on basal insulin use in type 2 diabetes have documented a significant reduction of hypoglycemia (overall and/or nocturnal) by as much as 30%.21 Francesca Porcellati and co-workers22 and Philip Home and colleagues17 discuss the data in more detail in this supplement.Both fasting hyperglycemia and postprandial hyperglycemia contribute to the rise in A1c values in patients with type 1 or 2 diabetes. There has been a debate as to the main contributor to overall hyperglycemia. It has been proposed that it is postprandial hyperglycemia in relatively well-controlled patients and fasting plasma glucose in the uncontrolled patients with type 2 diabetes.23 Louis Monnier and colleagues discuss these factors in this supplement at greater length.24 In addition, recent data presented by Riddle et al.25 at the American Diabetes Association and European Association for the Study of Diabetes meetings in 2010 showed similar but larger contributions (70–80%) by elevated fasting plasma glucose to the rise in A1c levels across all levels of glucose control (A1c from 8% to >10%) in patients with type 2 diabetes without initiating basal insulin therapy, thus challenging Monnier's concept. Consideration of these parameters is important in determining the ideal therapeutic approach to improving glucose control in patients by individualizing therapy.Many patients will eventually need additional agents in order to maintain their desired glycemic control. These agents (DPP-IV inhibitor and GLP analogs) allow for the targeted reduction of postprandial glucose without an increased risk for hypoglycemia.26 A recent investigator–initiated pilot study using DPP-IV inhibitor, sitagliptin, in patients with type I diabetes reported improved A1c values and better glucose variability indices as documented by continuous glucose monitoring data.27 “GLP-1 mimetics target postprandial glucose and should complement the activity of basal insulins; they are also associated with a relatively low risk of associated hypoglycemia and moderate, but significant, weight loss.”28 Many other studies have previously shown improvements in glycemic control, weight loss and/or reduced weight gain, and lower hypoglycemic events when GLP-1 analogs were compared with premixed insulin or insulin glargine with or without oral hypoglycemic agents and/or metformin.28–31 Buse et al.32 recently reported improved glucose control with less weight gain from the first randomized trial combining insulin glargine and exenatide (off-label). Generally, patients with type 2 diabetes have an increased mortality due to cardiovascular disease and cancer, decreasing their life expectancy. “Current recommendations for a healthy lifestyle based on good diet, physical exercise, and weight management in order to control diabetes-related complications are likely to apply in reducing the risk of many forms of cancer and should be advocated for all patients.”33 George Dailey analyzes the current impact of diabetes on mortality and the methods to help improve mortality in patients with diabetes in this supplement.33The use of devices to monitor glucose and/or deliver insulin (pens and pumps) has significantly impacted diabetes care for insulin-requiring patients with diabetes. With the development of continuous glucose monitoring, more patients requiring insulin treatment are obtaining better glycemic control with more time spent in the euglycemic range with fewer hypoglycemic events.34–36 Many companies are currently working on a closed-loop system that will link continuous glucose monitoring with insulin pumps creating an artificial pancreas.37 Alfred Penfornis and colleagues explain the evolution of devices in diabetes management in more depth in this supplement.38Since the use basal insulin alone or in combination with oral agents has become the cornerstone of diabetes management,39 many pharmaceutical companies have been working to develop even better basal insulins. The basal insulins that are currently in development have the potential to have an even greater impact on the treatment of diabetes. Novo Nordisk and Eli Lilly have new basal insulins that look to transform the field and may improve glycemic control with reduced hypoglycemic episodes and glucose variability.40 CeQur is taking a different approach by using a patch pump to deliver insulin continuously. Similarly, V-GO (Valeritas) recently got Food and Drug Administration clearance41 for another patch pump that can continuously deliver a rapid-acting-insulin analog (aspart) as a basal insulin. Additionally, smartly engineered insulins are currently in preclinical testing that have a built-in sensor to release the required amount of insulin.42 The future of diabetes management is discussed further by Airin Simon and Hans DeVries.43We would like to thank all of the authors who contributed to this supplement for their hard work. This supplement would not have been possible without their time and dedication.Author Disclosure StatementS.K.G. has received grants for clinical research from and is on Advisory Boards for Novo Nordisk, Eli Lilly and Company, Merck, Mannkind, Biodel, Halozyme, DexCom Inc., and Sanofi-Aventis. He discloses that he does not have any stocks for any pharmaceutical or device companies. E.G.M. reports no conflicts of interest.References1 www.diabetes.org/diabetes-basics/diabetes-statistics/?utm_source=WWW&utm_medium=DropDownDBJanuary2011.1. www.diabetes.org/diabetes-basics/diabetes-statistics/?utm_source=WWW&utm_medium=DropDownDB (accessed January 2011). Google Scholar2 Shaw JESicree RAZimmet PZGlobal estimates of the prevalence of diabetes for 2010 and 2030Diabetes Res Clin Pract200587414.2. Shaw JE, Sicree RA, Zimmet PZ: Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract 2005;87:4–14. 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Link, Google ScholarFiguresReferencesRelatedDetailsCited byImproving drug-like properties of insulin and GLP-1 via molecule design and formulation and improving diabetes management with device & drug deliveryAdvanced Drug Delivery Reviews, Vol. 112Closed-Loop System in the Management of Diabetes: Past, Present, and Future Viral N. Shah, Aaron Shoskes, Beshoy Tawfik, and Satish K. Garg29 July 2014 | Diabetes Technology & Therapeutics, Vol. 16, No. 8Use of Non-Insulin Therapies for Type 1 Diabetes Satish K. Garg, Aaron W. Michels, and Viral N. Shah1 November 2013 | Diabetes Technology & Therapeutics, Vol. 15, No. 11The Future of Basal Insulin Viral N. Shah, Emily G. Moser, Aaron Blau, Megha Dhingra, and Satish K. Garg28 August 2013 | Diabetes Technology & Therapeutics, Vol. 15, No. 9Obesity and Diabetes: Newer Concepts in Imaging Kavita Garg, Samuel Chang, and Ann Scherzinger1 May 2013 | Diabetes Technology & Therapeutics, Vol. 15, No. 5 Volume 13Issue S1Jun 2011 InformationCopyright 2011, Mary Ann Liebert, Inc.To cite this article:Satish K. Garg and Emily G. Moser.How Basal Insulin Analogs Have Changed Diabetes Care.Diabetes Technology & Therapeutics.Jun 2011.S-1-S-4.http://doi.org/10.1089/dia.2011.0072creative commons licensePublished in Volume: 13 Issue S1: June 13, 2011PDF download