Advances in Insulin Delivery Systems - Episode 7
An expert endocrine clinical pharmacist and nurse practitioner discuss clinical trial data on how inhaled insulin affects glucose management in T1D and T2D.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: What do we know about glucose management with inhaled insulin from clinical trials? Natalie, can you share some of it?
Natalie Bellini, DNP, FNP-BC: One of the things that we know from the STAT study is that, overall, those with type 1 on aspart, which is one of the meal insulins, achieved comparable time in range. Dr Isaacs and I are big time-in-range fans because it’s an easily explainable statistic to a patient that we want them, most patients, in range 70 percent of the time and reducing those highs and lows. When you compare it to aspart, the time in range is similar, but less time is spent hypoglycemic. What do you think?
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: Oh, for sure. Not overtreating the highs and the fact that it wears off more quickly definitely helps so much with the hypoglycemia. We see that it’s one of the reasons a regular insulin like your NPH [neutral protamine Hagedorn] insulin is more likely to lead to hypoglycemia, because it’s just hanging out in the body. Let’s say someone’s like, “I want to go exercise now.” Well, that insulin is still working in their body, and they eat extra food, and it’s a whole ordeal.
Natalie Bellini, DNP, FNP-BC: I absolutely agree. When we do a trial and give someone a medication, we have them bring back their pills, and we do pill counts. In trials with inhaled insulin, they measure whether or not the patient is actually using it. In those patients in the STAT study who were using it, the TI [Technosphere insulin]-compliant group were the patients who were using it consistently, and the time in range was significantly better. It went up to 62 percent from 53 percent. That’s about a 10 percent difference. That to me is a big deal, too. If you’re going to use it and use it the way that it was indicated to do so, your time in range increases significantly.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: They say every 5 percent increase in time in range is clinically significant, so 10 percent is a big deal.
Natalie Bellini, DNP, FNP-BC: Finally, they found that there was some weight loss with the Afrezza group and some weight gain with the aspart group.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: I’m not surprised, because someone is getting ready to exercise, and now has to eat all of this extra food. We talk about the rule of 15, which is taking 15 grams of fast-acting carbs, but in the moment, it’s really hard to just eat 15 grams. What happens is people do eat more, which can lead to weight gain, but also leads to more hyperglycemia.
Natalie Bellini, DNP, FNP-BC: When you are hyperglycemic and then you treat it with insulin and become hypoglycemic, you have to eat again. It’s both sides. People who overtreat low blood sugars end up high, and then they take insulin and end up low. Then, they consume so many more calories than they think they do, and we see that that causes weight gain. It’s a combination of different things.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: There’s data to suggest that when there’s more glycemic variability, that roller coaster of going up and down, [it] leads to worse cardiovascular outcomes.
Natalie Bellini, DNP, FNP-BC: Exactly. The patients who used the Technosphere insulin actually had less hypoglycemia at all of the levels: 1, 2, and 3.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: That’s awesome. Any other clinical data you would like to share?
Natalie Bellini, DNP, FNP-BC: The AFFINITY trial, in patients with type 1 receiving basal insulin, the [HbA1C] reduction with type 1 was noninferior. What we need to remember about this is that they had less hypoglycemia, or less weight gain, but a slightly increased incidence of cough, but with that outcome specifically is that patients should be given the option. Sometimes, we put things in compartments and forget about offering options, and it’s important that we remember that part of what we’re doing is, if it’s noninferior, which means, if it’s more convenient for the patient, then let’s give it a try. I do have patients who only use inhaled insulin at 1 meal a day. They only use it at lunch. I don’t care how they get their insulin in. We need to expand our thought and use that IFCC framework to say, “They’re struggling with lunch. Maybe start there.” Then, they might decide to take it at dinner, and we can use some of these background studies to say, “Where does this play a role?”
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: Or, even just using it for correction doses. There’s nothing to say that a person shouldn’t be using different insulin at mealtimes, but to be able to correct high glucose levels is important to have as a tool in their toolbox. To summarize, we’ve seen from these trials that there can be less hypoglycemia and improved time in range. It’s definitely noninferior to other options, which offers another tool in the toolbox to be able to deliver insulin.
Transcript edited for clarity