This transcript has been edited for clarity.
The U.S. Food and Drug Administration's Endocrine Advisory Committee voted against recommending approval of once-weekly insulin Icodec to treat people with diabetes. Type 1 diabetesThe vote was 7 to 4. The reasons for the no vote were: Hypoglycemia Weekly icodec was compared with standard care.
This data is ONWARDS 6 TRIALIn a study conducted by the American College of Cardiology (AACSB), 582 people with type 1 diabetes were randomly assigned to one of two regimens. One regimen consisted of Icodec plus 10 mg of glycemic control before meals. Insulin Aspart And one is Insulin degludec They were given insulin aspart before meals. The researchers followed the patients for a year and found that overall, there was no difference between the two groups in terms of blood sugar control, except that patients taking Icodec had a higher incidence of mild and severe hypoglycemia.
The increased risk of hypoglycemia is likely due to the peak of once-weekly icodec. Its hypoglycemic effect peaks 2-4 days after injection. This occurs even after the patient has stabilized. During that period, the risk of hypoglycemia is increased. During that period, the patient should theoretically reduce their dose of fast-acting insulin to account for the greater effect of the long-acting insulin. This is somewhat difficult for the general population to achieve, or at least for those who are not participating in clinical trials.
Overall safety showed no disparities in deaths or other serious adverse events, except for hypoglycemia or discontinuation. At week 57, insulin Icodec was associated with a 50% higher rate of hypoglycemia and an 80% higher event rate.
These high rates were observed regardless of whether hypoglycemia was detected by fingerstick glucose monitoring or continuous glucose monitoring. The risk was higher 2 to 4 days after the weekly injection, and time below range (i.e., below 54) was longer in the insulin Icodec group. Hypoglycemic episodes were similar in duration, management, and recovery; they were just more frequent in patients taking Icodec.
There are some suggestions to try to find ways to reduce the risk of hypoglycemia. To me, they are a bit complicated, but they make some sense. The patients with the highest coefficient of variation were the worst off. One way to reduce some of the risk is to only select patients with a low coefficient of variation, that is, a coefficient of variation of 36% or less.
Everyone taking this insulin should wear a continuous glucose monitor to address the increased risk of hypoglycemia. People with a history of hypoglycemia unawareness or severe hypoglycemia should not take it. Obviously, I think if you have hypoglycemic symptoms that cannot be alleviated, you should stop taking it. I think education will be key, because you will need to reduce your insulin dose somewhat on days 2-4 after your weekly injection.
These are the recommendations from the company. I think if you give this more frequently, say twice a week, it will work, but that's difficult. I'm talking about people with type 1 diabetes. This is actually, Type 2 diabetes. Clinical Trials It has been shown that there is no increased risk of hypoglycemia in type 2 diabetes patients. The idea of combining both for patients on basal insulin and weekly incretin therapy is a good one. It makes sense to me.
This is a problem for people with type 1 diabetes, and I have long held the hope that once-weekly insulin could help those at risk for diabetes. Diabetic ketoacidosis Just getting some basal insulin into your system will prevent other complications as well, so I need to see how this works and how it actually addresses the risk of hypoglycemia, because hypoglycemia is the biggest limiting factor for insulin use in my patients.
That's Dr. Anne Peters from Medscape. Thank you very much.