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Canadian surgeon Frederick Banting and his assistant, Charles Best, discovered insulin in 1921. On January 11, 1922, they administered the first dose of insulin to a human: 14-year-old Leonard Thompson. Insulin saved Thompson's life.
Since that historic event, there have been many real and perceived barriers regarding insulin therapy. Although insulin was literally a lifesaver for those with type 1 diabetes, it was long recognized as a double-edged sword because of the risk posed by overdose resulting in hypoglycemia. As recently as the 1980s and 1990s, insulin was considered a burdensome and potentially dangerous "therapy of last resort" for those with type 2 diabetes. The VA Cooperative Study, published in 1995, showed that elderly patients with type 2 diabetes had a relatively high rate of cardiovascular events, which many observers inappropriately attributed to intensive insulin therapy.1
The assumption that patients fear needles adds to unfounded negativity about insulin therapy. Only a small minority of patients have such fears, and these patients can opt for inhaled insulin ("Inhaled Insulin Shows Short-term Safety," page 1). But the real issue is not subcutaneous versus pulmonary insulin—it's that insulin is not offered early enough in type 2 diabetes. The typical delay in initiating insulin in poorly controlled type 2 diabetes is probably at least several years, suggest studies demonstrating similar delays in medication adjustments in patients who are suboptimally controlled on multiple oral agents with average glycated hemoglobin (A1C) levels of 9.2%.2
The American Diabetes Association/European Association for the Study of Diabetes treatment algorithm for type 2 diabetes published in 2006 proposes insulin therapy as potential second-line therapy, along with metformin, in patients not reaching treatment goals.3 Indeed, with controversy surrounding the use of thiazolidinediones (TZDs), and with the advent of simple insulin pen-delivery systems, the time for earlier and aggressive use of insulin in type 2 diabetes is now.
BENEFICIAL EFFECTS
In a sense, insulin therapy has come full circle over the past decade; in this period, we have learned much about its multiple beneficial effects. In addition to its glucose-lowering effect, insulin therapy improves the typical dyslipidemia of diabetes by lowering triglycerides and raising HDL levels. Reductions in free fatty acid, glucose, and triglyceride levels may at least partially explain the favorable vasodilatory effects observed with insulin.4
There is consensus among endocrinologists that insulin most likely improves beta-cell function in type 2 diabetes. The Diabetes Mellitus Insulin Glucose Infusion in Acute Myocardial Infarction (DIGAMI) Study Group used insulin to achieve intensive glycemic control among type 2 diabetes patients who experienced myocardial infarction. A glucose/insulin infusion started at the time of acute myocardial infarction followed by aggressive injection therapy reduced long-term mortality by 30–50% in type 2 patients not previously treated with insulin.5 Thus, it appears insulin's benefits range beyond its glucose-lowering capabilities, though there have been some mixed research results in this regard. Specifically, the DIGAMI2 study resulted in more controversy about insulin benefits than did DIGAMI1 (DOC News, October 2004, page 4).
INSULIN PEN ADVANTAGES
Finding time to teach and demonstrate the safe and appropriate administration of mixed-insulin injections with vial and syringe is difficult for health care providers. Without question, this has impeded timely initiation of insulin therapy in primary care settings. However, the development of pen-delivery devices has truly revolutionized the ease of insulin therapy initiation in the clinic. I am convinced that safe and effective teaching of injection therapy with pen devices can be achieved in 5 minutes.
And there are more choices available than ever before: Insulin pen devices, which have been available for >20 years, continue to improve, and nearly a dozen insulin preparations are available in pen format.
Most patients will not avoid starting insulin therapy if the need to do so is presented positively. I have personally started hundreds of type 2 diabetes patients on injection therapy and have never had a patient absolutely refuse. It seems that physicians are the ones who really fear insulin because of uncertainty about dosage, concerns that patients won't inject as prescribed, anticipation that insulin management will be time-consuming, and worry that insulin will spur hypoglycemia: One study found that, when initiating basal insulin therapy in type 2 diabetes, physicians feared nocturnal hypoglycemia almost twice as much as patients did.6
Physicians need to realize that with insulin pens, predetermined dosages keep patients' insulin levels on track, deter hypoglycemia, and ease patient management. Moreover, the injections are virtually painless. We encourage patients to inject insulin with their pens before leaving the Utah Diabetes Center to prepare for "solo" injections at home. The typical response is, "I didn't feel the injection at all."
Most patients who switch from conventional vial-and-syringe therapy to pen devices will not notice a significant change in glycemic control. However, several studies have demonstrated patient preference for and ease of use with insulin pen-delivery devices.7 In addition, patients using pen devices express greater confidence about injecting insulin accurately with the pen versus conventional injection therapy. Patient compliance and quality of life have been shown to improve with insulin pen devices. One should note, however, that many pen-device studies have been short-term and pharmaceutical company-sponsored.
A more recent study of patients with type 2 diabetes transitioning from traditional vial-and-syringe therapy to insulin pens showed a significant improvement in medication adherence and a reduced likelihood of hypoglycemic events.8 Hypoglycemia-associated emergency department and physician visits dropped. And annual diabetes-associated costs were reduced by $600 per patient, and total annual treatment costs fell by $1,590.
FORMULARY ISSUES
Perhaps the biggest barrier to adoption of pen devices is health insurers. Many patients can expect to pay a higher co-pay or out-of-pocket cost for a prefilled insulin pen than for an equivalent amount of insulin in vials. Medicaid and some insurance carriers will not cover the cost of insulin pen devices unless the patient has significant vision loss. And even though injecting with a reusable pen would, over the long term, cost less than using disposable ones (and be more environmentally friendly), insurance companies typically won't cover the cost of reusable pens because they consider them to be durable medical equipment.
In summary, the many beneficial metabolic and vascular effects of insulin
therapy extend far beyond lowering blood glucose. Insulin therapy needs to be
considered much earlier in the course of type 2 diabetes, especially in
patients who remain poorly controlled despite the use of one or more oral
medications. One can demonstrate the use of insulin pen-delivery devices
quickly and easily in the outpatient setting, within a few minutes. Gone are
the days of burdensome patient education on insulin therapy. 
Footnotes
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More information on insulin pens is available from the three companies that sell the devices, Eli Lilly and Company, Novo Nordisk, and Sanofi-Aventis, at www.lillydiabetes.com, www.novonordisk-us.com, and www.sanofi-aventis.us.
Note of Disclosure: Chamberlain is a speaker for Eli Lilly and Company, Amylin Pharmaceuticals, and Sanofi-Aventis.
References
2. Brown JB, Nichols GA, Perry A, et al.: The burden of treatment
failure in type 2 diabetes. Diabetes Care 27: 1535–1540, 2004.
3. Nathan DM, Buse JB, Davidson MB, et al.: Management of hyperglycemia in type 2 diabetes: A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 49:1711–1721, 2006.[Medline]
4. Vehkavaara S, Mäkimattila S, Schlenzka A, et al.: Insulin
therapy improves endothelial function in type 2 diabetes.
Arterioscler Thromb Vasc Biol 20: 545, 2000.
5. Malmberg K, for the DIGAMI (Diabetes Mellitus, Insulin Glucose
Infusion in Acute Myocardial Infarction) Study Group: Prospective randomised
study of intensive insulin treatment on long term survival after acute
myocardial infarction in patients with diabetes mellitus.
BMJ 314:1512–1515, 1997.
6. Fritsche A, Häring H-U, Tögl E, Schweitzer M-A, the HOE901/4001 Study Group: Treat-to-target with add-on basal insulin: Can glargine reduce barrier to target attainment? (Abstract). Diabetes 52 (Suppl. 1): A119, 2003.
7. Rubin R, Peyrot M: Quality of life, treatment satisfaction, and
treatment preference associated with use of a pen device delivering a premixed
70/30 insulin aspart suspension (aspart protamine suspension/soluble aspart)
versus alternative treatment strategies. Diabetes Care 27: 2495–2497, 2004.
8. Lee WC, Balu S, Cobden D, et al.: Medication adherence and the associated health-economic impact among patients with type 2 diabetes mellitus converting to insulin pen therapy: An analysis of third-party managed care claims data. Clin Ther 28:1712–1725, 2006.[Medline]
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