TY - JOUR
T1 - A randomized, open-label comparison of once-weekly insulin icodec titration strategies versus once-daily insulin glargine u100
AU - Lingvay, Ildiko
AU - Buse, John B.
AU - Franek, Edward
AU - Hansen, Melissa V.
AU - Koefoed, Mette M.
AU - Mathieu, Chantal
AU - Pettus, Jeremy
AU - Stachlewska, Karolina
AU - Rosenstock, Julio
N1 - Publisher Copyright:
© 2021 by the American Diabetes Association.
PY - 2021
Y1 - 2021
N2 - OBJECTIVE Insulin 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-naive adults (n = 205) with type 2 diabetes and HbA1c 7–10% while treated with oral glucose-lowering medications initiated once-weekly icodec titrations A (prebreakfast self-measured blood glucose target 80–130 mg/dL; adjustment ±21 units/week; n = 51), B (80–130 mg/dL; ±28 units/week; n = 51), or C (70–108 mg/dL; ±28 units/week; n = 52), or once-daily insulin glargine 100 units/mL (IGlar U100) (80–130 mg/dL; ±4 units/day; n = 51), all titrated weekly. Percentage of time in range (TIR) (70–180 mg/dL) during weeks 15 and 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 and 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 to 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 of exposure for icodec titrations A, B, and C and IGlar U100, respectively), with no episodes of severe hypoglycemia. CONCLUSIONS Once-weekly icodec was efficacious and well tolerated across all three titration algorithms investigated. The results for icodec titration A (80–130 mg/dL; ±21 units/week) displayed the best balance between glycemic control and risk of hypoglycemia.
AB - OBJECTIVE Insulin 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-naive adults (n = 205) with type 2 diabetes and HbA1c 7–10% while treated with oral glucose-lowering medications initiated once-weekly icodec titrations A (prebreakfast self-measured blood glucose target 80–130 mg/dL; adjustment ±21 units/week; n = 51), B (80–130 mg/dL; ±28 units/week; n = 51), or C (70–108 mg/dL; ±28 units/week; n = 52), or once-daily insulin glargine 100 units/mL (IGlar U100) (80–130 mg/dL; ±4 units/day; n = 51), all titrated weekly. Percentage of time in range (TIR) (70–180 mg/dL) during weeks 15 and 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 and 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 to 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 of exposure for icodec titrations A, B, and C and IGlar U100, respectively), with no episodes of severe hypoglycemia. CONCLUSIONS Once-weekly icodec was efficacious and well tolerated across all three titration algorithms investigated. The results for icodec titration A (80–130 mg/dL; ±21 units/week) displayed the best balance between glycemic control and risk of hypoglycemia.
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U2 - 10.2337/dc20-2878
DO - 10.2337/dc20-2878
M3 - Article
C2 - 33875484
AN - SCOPUS:85104941019
SN - 0149-5992
VL - 44
SP - 1595
EP - 1603
JO - Diabetes care
JF - Diabetes care
IS - 7
ER -