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  • More New Diabetes Drugs; More Diabetes to Treat


    Diabetes is an ongoing epidemic in our country, worsening the quality of life for millions of individuals and creating significant costs within the healthcare system. It is estimated that 25.8 million children and adults in the United States have diabetes, which accounts for 8.3% of our population.1 There are currently 79 million Americans who are prediabetic and at risk for developing type 2 diabetes.2 About 24 million people have type 2 diabetes, which translates to over 90% of all diagnosed cases. It is projected that by the year 2050 as many as one in every three adults will have diabetes.2 Fortunately the options for diabetes care are expanding, including new drug options such as Invokana (canagliflozin) tablets, Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets.

    In order to prevent acute complications in patients and to reduce the risk of long-term complications, ongoing care as well as counseling and support for self-management are crucial. Serious complications for diabetic patients are common due to the risk factors associated with having chronic high blood sugar levels. Between 60 and 70% of diabetic individuals develop secondary problems such as slower digestion, sexual dysfunction, and nerve damage leading to peripheral neuropathy. Individuals with diabetes account for a 10 times higher rate of amputation than for those who are not diabetic. Heart disease and stroke are also serious risks, with two out of three people with diabetes dying from these complications. Diabetes has been identified as the leading cause of kidney failure, as well as of new cases of blindness among adults.2 Unfortunately, a diagnosis for type 2 diabetes often will not come until after one or more of these or other complications arise. Undiagnosed individuals may account for nearly one-fourth of those who actually have the disease.3 To address this, we can follow established guidelines3 related to testing for diabetes in individuals who are asymptomatic:

    1. Testing should be considered in all adults who are overweight (BMI ≥25 kg/m2 [at-risk BMI may be lower in some ethnic groups]) and have additional risk factors:
      • physical inactivity
      • first-degree relative with diabetes
      • high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander)
      • women who delivered a baby weighing >9 lb or were diagnosed with GDM
      • hypertension (≥140/90 mmHg or on therapy for hypertension)
      • HDL cholesterol level <35 mg/dL (0.90 mmol/L) and/or a triglyceride level >250 mg/dL (2.82 mmol/L)
      • women with polycystic ovary syndrome
      • A1C ≥5.7%, IGT, or IFG on previous testing
      • other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans)
      • history of CVD
    2. In the absence of the above criteria, testing for diabetes should begin at age 45 years.
    3. If results are normal, testing should be repeated at least at 3-year intervals, with consideration of more frequent testing depending on initial results (e.g., those with prediabetes should be tested yearly) and risk status.

    Discovering and addressing prediabetes could be a tremendous aid in controlling expenditures related to diagnosed diabetes. The recent costs tied to the disease are astounding. In total, $245 billion is related to diagnosed diabetes, a figure that includes both direct medical costs as well as indirect costs, such as loss of work.1 An estimated one out of every 10 dollars related to healthcare goes toward treating diabetes and its complications.2 The health implications of the complications depict how severe the epidemic is, and the enormity of the financial aspect further defines its vast scope. Effective treatment for those who are diagnosed is crucial, and current pharmacological recommendations3, available from the American Diabetes Association, give necessary guidance for implementing therapy. These include:

    • Insulin therapy for type 1 diabetes
      • Most people with type 1 diabetes should be treated with MDI injections (three to four injections per day of basal and prandial insulin) or continuous subcutaneous insulin infusion.
      • Most people with type 1 diabetes should be educated in how to match prandial insulin dose to carbohydrate intake, premeal blood glucose, and anticipated activity.
      • Most people with type 1 diabetes should use insulin analogs to reduce hypoglycemia risk.
      • Consider screening those with type 1 diabetes for other autoimmune diseases (thyroid, vitamin B12 deficiency, celiac) as appropriate.
    • Pharmacological therapy for hyperglycemia in type 2 diabetes
      • Metformin, if not contraindicated and if tolerated, is the preferred initial pharmacological agent for type 2 diabetes.
      • In newly diagnosed type 2 diabetic patients with markedly symptomatic and/or elevated blood glucose levels or A1C, consider insulin therapy, with or without additional agents, from the outset.
      • If noninsulin monotherapy at maximal tolerated dose does not achieve or maintain the A1C target over 3-6 months, add a second oral agent, a glucagon-like peptide-1 receptor agonist, or insulin.
      • A patient-centered approach should be used to guide choice of pharmacological agents. Considerations include efficacy, cost, potential side effects, effects on weight, comorbidities, hypoglycemia risk, and patient preferences.
      • Due to the progressive nature of type 2 diabetes, insulin therapy is eventually indicated for many patients with type 2 diabetes.

    New pharmacological treatments for diabetes are available and can be integrated into treatment plans. The FDA has recently approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering elevated blood glucose levels.4 Additionally, the FDA has approved three new related products for use with diet and exercise to improve glycemic control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets. Alogliptin is a new active ingredient, while metformin hydrochloride and pioglitazone have already been FDA-approved for the management of type 2 diabetes.5 New options for treating diabetes are also on the horizon, as evidenced by the Technosphere Insulin Inhalation Powder phase 3 clinical trial. This trial is designed to examine the efficacy and safety of inhaled prandial insulin in combination with basal insulin versus insulin aspart in combination with basal insulin in subjects with type 1 diabetes who are suboptimally controlled with their current insulin regimens. This trial will employ a variety of methods to intensively manage these subjects.6

    PDR Network can be a useful resource for information on available products used to treat diabetes, as well as other drug types, offering alerts and specific product labeling. Keep current with information on products by using PDR.net and by keeping your contact information up to date at PDR.net. If you use an electronic health record (EHR), please ask for it to include the PDR drug data feeds, including PDR BRIEF, which delivers updated drug information, full labeling, and safety warnings integrated into your electronic prescribing system automatically and at NO cost to you. Drug information in EHRs is often months out of date, which is why PDR BRIEF is available at no cost to providers and EHR vendors.

    Salvatore Volpe, MD, FAAP, FACP, CHCQM
    Chief Medical Officer
    PDR Network


    1American Diabetes Association. Diabetes Statistics [article online]. Available at www.diabetes.org/diabetes-basics/diabetes-statistics. Accessed November 1, 2013.

    2American Diabetes Association. American Diabetes Month 2013 Fact Sheet [article online]. Available at www.diabetes.org/in-my-community/programs/american-diabetes-month/adm-2013-fact-sheet.pdf. Accessed November 1, 2013.

    3American Diabetes Association. Standards of Medical Care in Diabetes—2013. Diabetes Care. 2013;36(1 Suppl):S11-S66.

    4U.S. Food and Drug Administration. FDA News Release: FDA approves Invokana to treat type 2 diabetes [article online]. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345848.htm. Accessed November 1, 2013.

    5U.S. Food and Drug Administration. FDA News Release: FDA approves three new drug treatments for type 2 diabetes [article online]. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336942.htm. Accessed November 1, 2013.

    6U.S. National Institutes of Health. ClinicalTrials.gov listing: Clinical Trial Evaluating Technosphere Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period [article online]. Available at http://clinicaltrials.gov/ct2/show/NCT01445951. Accessed November 1, 2013.