Mannkind Corporation presented their three late-breaking posters at the 76th Scientific Sessions of the American Diabetes Association or ADA, with four additional analyses for Afrezza Inhalation Powder or insulin human. They reported a faster onset and shorter duration of action of their lead candidate drug as compared with rapid-acting insulin analogs for patients having diabetes mellitus.
FDA approved Afrezza in 2014 for the treatment of patients with type 1 and type 2 diabetes milletus because it can help improve glycemic control. Afrezza is the only product with inhaled form of insulin sold in the US.
The company presented a controlled, randomized, crossover dose-response and six treatment study. In the first poster, Afrezza was compared with Lispro, a rapid-acting insulin analog. Thirty patients with type 1 diabetes milletus participated in the study.
Results show that across the studies, the onset of action of Afrezza is 16 to 21 minutes faster as compared with 45 to 52 minutes for insulin drug administered subcutaneously. At clinically relevant doses, the duration of action of Afrezza is shorter by 2 to 3 hours. The labeled dose of Afrezza overestimates the drug effect thus there is a need for appropriate titration of doses.
A similar result was reported in the second poster. The company conducted another meta-analysis with three open-label clamp trial. They compare Afrezza’s onset of action with a regular human insulin or Lispro. Afrezza was 25 to 34 minutes faster than 53 to 60 minutes with subcutaneous Lispro.
The data confirms that Afrezza has faster onset of action as compared with subcutaneous insulin which is relevant in optimal dosing. It also supports Afrezza’s claims for using it to rapidly control high glucose levels.
People having type 1 diabetes and type 2 diabetes inject rapid-acting insulin analogs to prevent elevated blood sugar levels caused by taking food. If blood sugar levels drops, a person may suffer a dangerous condition called hypoglycemia. It usually happens when the effect of a rapid-acting insulin analog extends the food absorption or past mealtime.
In the US, insulin-related hypoglycemia results in almost 100,000 hospital visits a year. In 2007 to 2011, US spent over $600 million between these five-year periods.
Raymond W. Urbanski, MD, PhD, Mannkind’s Chief Medical Officer said that when administering an injectable rapid-acting insulin analog or inhaled-rapid acting insulin, it is important to balance the prandial glucose control to minimize the risk of post-prandial hypoglycemic events. Urbanski also added that Afrezza begins to work more rapidly in the body and it leaves the bloodstream faster than the injectable form of rapid-acting insulin analog. This may translate more flexibility in terms of timing of administration and lower potential of having hypoglycemic episodes after taking a meal.
In the third poster, additional data was presented to highlight Afrezza’s dosing as compared with subcutaneous rapid-acting insulin. There is no single conversion factor that was used to fully describe the effect, but they noted that faster onset and shorter duration of action was maintained across the matched dosing. The investigators of the study concluded that it is important to titrate the dose for each patient.
In the pharmacodynamic and pharmacokinetic data, the investigators observed that 4 units of Afrezza have the same efficacy with 3.1 IU of Lispro.
Preventing Hypoglycemic Attacks
Patients with diabetes are at risk of having hypoglycemic attacks. Hence, there is a need for rapid-acting insulin analogs to prevent this from happening. But, it is very important for the patients to administer the drug at the proper interval or else an insulin-related hypoglycemia may occur. Afrezza is a potential drug that offers faster onset of action with shorter-duration of effect which will be very helpful for patients with type 1 and type 2 diabetes.