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

被引:64
作者
Lingvay, Ildiko [1 ,2 ]
Buse, John B. [3 ]
Franek, Edward [4 ]
Hansen, Melissa V. [5 ]
Koefoed, Mette M. [5 ]
Mathieu, Chantal [6 ]
Pettus, Jeremy [7 ]
Stachlewska, Karolina [5 ]
Rosenstock, Julio [8 ]
机构
[1] Univ Texas Southwestern Med Ctr Dallas, Dept Internal Med, Endocrinol Div, Dallas, TX 75390 USA
[2] Univ Texas Southwestern Med Ctr Dallas, Dept Populat & Data Sci, Dallas, TX 75390 USA
[3] Univ N Carolina, Sch Med, Chapel Hill, NC USA
[4] Mossakowski Med Res Ctr, Warsaw, Poland
[5] Novo Nordisk AS, Soborg, Denmark
[6] Univ Leuven, Clin & Expt Endocrinol, Leuven, Belgium
[7] Univ Calif San Diego, Sch Med, San Diego, CA 92103 USA
[8] Dallas Diabet Res Ctr Med City, Dallas, TX USA
基金
美国国家卫生研究院;
关键词
TYPE-2; TRIAL; ADHERENCE; THERAPY; DETEMIR;
D O I
10.2337/dc20-2878
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 HbA(1c) 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.
引用
收藏
页码:1595 / 1603
页数:9
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