Which rapid-acting insulin treatments for type 2 diabetes mellitus (DM) are approved by the FDA?

Updated: Oct 23, 2019
  • Author: Romesh Khardori, MD, PhD, FACP; Chief Editor: George T Griffing, MD  more...
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Answer

A rapid-acting inhaled insulin powder (Afrezza) for types 1 and 2 diabetes mellitus was approved by the FDA in June 2014. Approval was based on a study involving over 3,000 patients over a 24-week period. In persons with type 1 diabetes, the inhaled insulin was found to be noninferior to standard injectable insulin when used in conjunction with basal insulin at reducing hemoglobin A1c. In persons with type 2 diabetes, the inhaled insulin was compared to placebo inhalation in combination with oral diabetic agents and showed a statistically significant lower hemoglobin A1c. [220]

The first inhaled insulin (Exubera) was approved by the FDA in January 2006 as a rapid-acting prandial insulin. It did not produce better glycemic control than did conventionally injected insulins, and it required a mildly cumbersome device and skill to deliver an accurate dose (up to a few minutes to deliver 1 dose) and pulmonary function monitoring due to concerns about lung toxicity over time. Exubera was withdrawn from the market in October 2007, not because of safety concerns but because too few patients were using the product for its continued sale to be economically feasible.

In September 2017, the FDA approved the rapid-acting insulin aspart Fiasp for the treatment of adults with diabetes. This human insulin analog is formulated with niacinamide, which aids in speeding the initial absorption of insulin. Dosing can occur at the beginning of a meal or within 20 minutes after the meal commences. In a study of adult patients with type 1 DM, Fiasp could be detected in the circulation about 2.5 minutes after it was administered. Maximum insulin levels occurred approximately 63 minutes after the drug’s administration. [221, 222]


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