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insulin ludefen + insulin aspart is a combination regimen consisting of insulin ludefen (GZR4), an investigational once-weekly ultra-long-acting basal insulin analog, and insulin aspart, a rapid-acting prandial (mealtime) insulin analog. Developed by Gan & Lee Pharmaceuticals, this regimen is designed for the treatment of type 2 diabetes mellitus. Insulin ludefen is engineered with structural modifications, including a C22 fatty diacid side chain, which enhances its binding to human serum albumin, thereby extending its half-life and allowing for once-weekly subcutaneous dosing. Insulin aspart is administered at mealtimes to control postprandial blood glucose. The combination regimen has been evaluated in the Phase III SUPER-3 trial (NCT06767761) in patients with type 2 diabetes previously treated with basal-bolus or premixed/dual insulin therapy, where it demonstrated superior HbA1c reduction compared to a daily insulin glargine U100 plus insulin aspart regimen.
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