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A Randomized, Open-Label Comparison of Once-Weekly Insulin Icodec Titration Strategies Versus Once-Daily Insulin Glargine U100

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posted on 16.04.2021, 22:16 by Ildiko Lingvay, John B. Buse, Edward Franek, Melissa V. Hansen, Mette M. Koefoed, Chantal Mathieu, Jeremy Pettus, Karolina Stachlewska, Julio Rosenstock
OBJECTIVE

Insulin icodec (icodec) is a novel once-weekly basal insulin analog. This trial investigated the efficacy and safety of icodec using different once-weekly titration algorithms.

RESEARCH DESIGN AND METHODS

This was a phase 2, randomized, open-label, 16-week, treat-to-target study. Insulin-naïve adults (n = 205) with type 2 diabetes and HbA1c 7–10% while treated with oral glucose-lowering medications initiated once-weekly icodec titrations A (pre-breakfast self-measured blood glucose target, 80–130 mg/dL; adjustment ±21U/week; n = 51), B (80–130 mg/dL; ±28U/week; n = 51), C (70–108 mg/dL; ±28U/week; n = 52), or once-daily insulin glargine U100 (IGlar U100; 80–130 mg/dL; ±4U/day; n = 51), all titrated weekly. Percentage time in range (TIR; 70–180 mg/dL) during weeks 15&16 was measured using continuous glucose monitoring.

RESULTS

TIR improved from baseline (means: A, 57.0%; B, 55.2%; C, 51.0%; IGlar U100, 55.3%) to weeks 15&16 (estimated mean: A, 76.6%; B, 83.0%; C, 80.9%; IGlar U100, 75.9%). TIR was greater for titration B than for IGlar U100 (estimated treatment difference: 7.08%-points; 95% CI, 2.12%–12.04%; P = 0.005). No unexpected safety signals were observed. Level 2 hypoglycemia (<54 mg/dL) was low in all groups (0.05, 0.15, 0.38, 0.00 events per patient/year for icodec titrations A, B, C, IGlar U100, respectively), with no episodes of severe hypoglycemia.

CONCLUSION

Once-weekly icodec was efficacious and well tolerated across all three titration algorithms investigated. Icodec titration A (80–130 mg/dL; ±21U/week) displayed the best balance between glycemic control and risk of hypoglycemia.

Funding

Novo Nordisk funded the trial and was responsible for trial design and data analysis. J.B.B.’s effort in this study was supported in part through grants from the NIH (UL1TR002489, P30DK124723).

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