Diabetes Update: The New Concentrated Insulin Products

In the US, approximately 22 million adults are living with diabetes; of these, 90–95% are classified as having type 2 diabetes (T2DM), a progressive disease in which beta cell function declines based on the duration of the disease and level of glycemic control. The American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE) both recognize that achieving and maintaining the patient’s glycemic goals are essential for the prevention, or delay in progression, of chronic complications associated with diabetes. However, about half of US adults are not meeting their glycemic goals. Based on the most recent data, 50% of adults with diabetes are taking only oral medications for glycemic control; at least 30% are using insulin, either in combination with oral therapy or as monotherapy. With the rising rates of obesity and T2DM, insulin is emerging as a “sooner rather than later” treatment option.

Why more insulin products? For the past several decades, pharmaceutical companies have attempted to develop insulin formulations that kinetically mimic endogenous insulin secretion. An ideal bolus insulin should have a rapid onset and short duration of action, while an ideal basal insulin would produce smooth or constant plasma levels over a prolonged duration. Although insulin products have improved over the years, there is no product that mimics physiologic insulin secretion exactly.

In 2015, the FDA approved 3 new concentrated insulin products (lispro U-200, glargine U-300, degludec U-200), and in 2016 a new prefilled delivery device for regular U-500 insulin was approved. Compared with neutral protamine Hagedorn (NPH) insulin, the new long-acting products more closely resemble an ideal basal insulin.

Insulin is considered a high-alert medication by the Institute for Safe Medication Practices in both the inpatient and outpatient settings. It is fraught with dosing, dispensing, and administration errors. The emergence of the concentrated insulin products challenges providers to educate both patients and other healthcare professionals about the differences, benefits, practical use, safety, and efficacy of these agents.