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GLYCEMIC CONTROL WITH ONCE WEEKLY BASAL INSULIN FC IN PERSONS WITH TYPE 2 DIABETES MELLITUS USING CONTINUOUS GLUCOSE MONITORING IN A PHASE 2 STUDY
Abstract
Background and Aims
Basal insulin Fc (BIF; LY3209590) is a novel, once-weekly, long-acting IgG Fc-fusion protein assessed for the treatment of diabetes mellitus. A 32-week study evaluating the safety and efficacy of BIF vs degludec in persons with type 2 diabetes mellitus (T2DM) previously treated with a basal insulin showed HbA1c non-inferiority of BIF vs degludec with significantly fewer hypoglycemic events (≤70 mg/dL). Here we present continuous glucose monitoring (CGM) data derived by Dexcom G6, allowing a more detailed assessment of glycemic control of BIF vs degludec.
Methods
The study included 2 dosing algorithms for BIF with different fasting glucose (FG) targets: ≤140 mg/dL (BIF-A1) and ≤120 mg/dL (BIF-A2). Degludec was titrated to FG ≤100 mg/dL. Subjects were randomized to 1 of the 3 arms.
Results
Subject (N=399) mean age was 60.2 yrs and baseline HbA1c was 8.1%. For the entire 32 weeks, the percent of 24 hrs in range, hyperglycemia and hypoglycemia was similar for the 3 arms (Figure). At Week 32, total duration of hypoglycemia was similar across 7 days post-injection for BIF-A1 and A2, showing that duration of hypoglycemia is independent of day post-injection.
Conclusions
CGM data confirm that BIF showed similar glycemic control vs degludec despite higher FG targets and numerically lower time in hypoglycemia. The flat pharmacokinetic profile enables near peakless insulin concentrations without an increase in hypoglycemia risk at highest exposure.