New Fast Acting Insulin Gets an FDA's Approval - Diabetes Health Page

New Fast Acting Insulin Gets an FDA’s Approval

By Gabriela | Diabetes

New Fast Acting Insulin Gets an FDA's Approval

Recently the FDA approved the insulin aspart injection from Novo Nordisk. This is a fast-acting insulin during mealtime that improves the glycemic control in people with type 1 diabetes and types 2 diabetes. (1)

This insulin aspart injection got the name Fiasp. Fiasp is a new formulation of NovoLog which includes niacinamide. The niacinamide, aids to increase the speed of the absorption of insulin. This injection needs to be administrated before a meal or within 20 after the meal. (2)

Creation of Fiasp

Producers of Fiasp created this product to match the physiological insulin mealtime response of people with diabetes. Along with niacinamide, i.e., vitamin B3, there is L-Arginine which is naturally occurring amino acid that also helps increase the speed of absorption.

This insulin injection got its approval thanks to the the clinical trials. These clinical trials showed that Fiasp leads to improvement in the glucose level in the long-term.

According to the trial researchers, there is comparable overall rate of serious or blood glucose confirmed hypoglycemia between aspart and Fiasp.

The third phase clinical program had four trials with around 2100 people with type 1 diabetes and type 2 diabetes. At the 53rd European Association for the Study of Diabetes Annual Meeting, there was presentation of data about this topic. (3)

According to that data in the first trial, over a 52-week study, divided into two, 26-week treatment periods, there is comparison between Fiasp and the conventional insulin aspart in people with type 1 diabetes.

Over this period, Fiasp showed a statistically notably greater overall blood glucose reduction of around -0.10 percent in adults that have type 1 diabetes. This is in comparison with the conventional insulin aspart. (4)

In addition, Fiasp showed a statistically notable reduction in one-hour post-meal glucose increment of around -0.91 mmol or L.

However, in the two-hour post-meal glucose increment there were no notable differences in comparison with the conventional insulin aspart.

New Hope

In October 2016, Novo Nordisk from the FDA received a CRL, i.e., Complete Response Letter for Fiasp. And later in March 29, 2017, resubmitted the new medication application.

In the video below PharmD, Jennifer Goldman talks about pipeline the diabetes medication. Also about the promise of this drug for treating people with diabetes type 2 in the future. Every new step, research and drug is a new hope for people with diabetes.