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One study that type 1 diabetes patients asked me from a conference of the American Diabetes Association was apex study, where stem cell-derived islet cells were administered to individuals with type 1 diabetes and lasted for a year. They reported on 12 participants, and essentially these small islet cells worked.
Of course, the problem and the reason I had to disappoint patients is because it didn't work without immunosuppression. These patients required immunosuppression, but in an immunosuppressive setting, small new islet cells worked.
An increase in C-peptide production was observed. Most patients got off insulin. The patient had no episodes of severe hypoglycemia and the patient was essentially treated for type 1 diabetes. At least a few people lasted for a year. Of course, the downside is immunosuppression, which is where the side effects occurred.
I think this was really interesting. Because it is certainly proof of concept that it can ingest stem cells, create islet cells, infuse them into humans and make them work. We have to find a way to do it without immunosuppression.
The next study that my patients and I found interesting came from the Barbara Davis Center and was conducted by Dr. Harris Akturk and his colleagues. We were considering using 1 mg of semaglutide as an adjunct to insulin in people with type 1 diabetes and obese using an automated insulin delivery system.
Currently, with full disclosure, I am always hoping to try this out-of-combined therapy with semaglutide in patients who are overweight or obese, but this is the first randomized controlled trial to show benefits.
This was called the Adjusted T1D Trial. It was a double-blind study. This is a 26-week placebo-controlled study, enrolling 72 individuals with type 1 diabetes from four US clinics. They were randomized to semaglutide or placebo weekly, continuing with the usual automated insulin delivery system.
Adjustment of insulin was guided by patients with and with patients examining range, subrange times, and other continuous glucose monitoring parameters. These individuals had a BMI ≥30 and between 7% and 10% of A1c had to appear in the study. These were fairly typical individuals with overweight type 1 diabetes, with a baseline A1C of 7.7%.
The main results are composite results, looking at the number of people who achieved time in the range of >70%, <4%, and >5% weight loss. This composite endpoint was filled with 36% of participants in the semaglutide group, which was extremely important compared to the placebo group.
Regarding secondary outcomes, there was a 0.7% decrease in A1C in the Semaglutide group compared to 0.3% in the placebo group. Time within range has been improved. On average, people lost 18 pounds, reducing their daily total insulin dose. There was no diabetic ketosidosis, but each group had two episodes of severe hypoglycemia.
I think this is truly a proof of concept and it shows that it is beneficial for all of us who deal with a lot of people with type 1 diabetes and use incretin therapy. What we still need to pay attention to is that I don't think this is good for anyone, so I think it's obviously too fast weight loss and the fact that people need less insulin is obviously weight loss because they need to reduce the insulin dose as people use these agents.
Patients with these automated insulin delivery systems tend to do quite well. I often adjust the sensitivity according to the carbohydrate ratio and perhaps the pump, but I've found this to be a fairly safe and effective method. I think you start lower and slowly rise and make sure the patient is tolerating the medication. I think patients really see benefits.
What's not measured here is the benefit of non-glycemia that we know, and I think that's important. In my own clinic, I looked at the results two years later retrospectively, and while people still remained weight loss, some of the improvements in blood sugar faded over time.
I think it just shows how difficult it is to manage people with type 1 diabetes. I think this would be helpful, but I think it was a really good test. I am very grateful to the investigators who conducted this research.
These two presentations highlight some of the progression in ways you are thinking about dealing with type 1 diabetes. First, the concept of having a treatment that hopefully one day helps people with type 1 diabetes has new beta cells that actually work. The second shows that we are using some of the drugs we are currently used to, and can be done safely and effectively, in terms of benefits for type 1 diabetes patients.
This was Dr. Anne Peters of Medscape. thank you.