Both studies examined insulin icodec, a new insulin analog that is designed to be taken once weekly as a basal insulin regimen. In theory, this once-weekly basal insulin could be used for either type 1 or type 2 diabetes. But since people with type 1 require multiple daily doses of mealtime insulin in some form, limiting basal insulin to a once-weekly injections would seem to offer little benefit to this group. Instead, insulin icodec is aimed at people with type 2 who may be hesitant to administer daily insulin injections, especially those who only require basal insulin therapy.
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Weekly insulin shows promise as basal therapy in studies
The first study involved 205 participants with type 2 diabetes from seven countries — the United States, Germany, Spain, Croatia, Hungary, Poland and Slovakia — who had never had insulin therapy before, but were considered candidates for it because they had an A1C level (a measure of long-term blood glucose control) between 7% and 10% while taking oral diabetes drugs. Participants underwent a two-week screening period, followed by 16 weeks of insulin therapy. They were randomly assigned to one of four different groups, making adjustments to their insulin dose based on glucose measurements throughout the week. Three of the groups took insulin icodec weekly, with each group having slightly different target glucose levels or making adjustments to their weekly dose in slightly different increments. The fourth group took insulin glargine (Lantus) daily.
During weeks 15 and 16 of the study, participants wore a continuous glucose monitoring (CGM) system to calculate the percentage of time spent within the target glucose range of 70 to 180 mg/dl. The researchers found that compared with before taking insulin, participants spent a much greater amount time in their target glucose range — 57.0%, 55.2% and 51.0% in each of the insulin icodec groups, and 55.3% in the insulin glargine group. There were no unexpected safety issues, and the rate of hypoglycemia (low blood glucose) was low in each group, with no episodes of severe hypoglycemia.
The second study involved 154 participants from five countries — the United States, Canada, Germany, Italy and the Czech Republic — who already took basal insulin for their type 2 diabetes, along with at least one oral diabetes drug. This study also lasted 156 weeks, with CGM during weeks 15 and 16. There were three different groups — the first group started with a “loading dose” of insulin icodec twice as large as following doses, the second group started with a regular dose of insulin icodec, and the third group took daily insulin glargine. During the last two weeks, the percentage of time in the target glucose range was 72.9% for the insulin icodec group with the loading dose, 66.0% for the group without any loading dose, and 65.0% for the insulin glargine group. The average A1C level (a measure of long-term blood glucose control) in the loading-dose group fell from 7.9% to 7.1%, while it fell from 7.9% to 7.1% in the other two groups.
The researchers in both studies concluded that insulin icodec showed strong promise as a basal insulin therapy for type 2 diabetes — performing at about the same level as, or better than, daily long-acting insulin injections. More studies and analysis are needed, however, before this new type of insulin is available to the general population.
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