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Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial

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posted on 27.05.2021, 10:20 by Harpreet S Bajaj, Richard M Bergenstal, Andreas Christoffersen, Melanie J Davies, Amoolya Gowda, Joakim Isendahl, Ildiko Lingvay, Peter A Senior, Robert J Silver, Roberto Trevisan, Julio Rosenstock

OBJECTIVE Insulin icodec (icodec) is a novel once-weekly basal insulin analog. This trial investigated two approaches for switching to icodec versus once-daily insulin glargine U100 (IGlar U100) in people with type 2 diabetes receiving daily basal insulin and one or more oral glucose-lowering medications.


RESEARCH DESIGN AND METHODS This multicenter, open-label, treat-to-target phase 2 trial randomized (1:1:1) eligible basal insulin–treated (total daily dose 10–50 units) people with type 2 diabetes (HbA1c 7.0–10.0% [53.0–85.8 mmol/mol]) to icodec with an initial 100% loading dose (in which only the first dose was doubled [icodec LD]), icodec with no loading dose (icodec NLD), or IGlar U100 for 16 weeks. Primary end point was percent time in range (TIR; 3.9–10.0 mmol/L [70–180 mg/dL]) during weeks 15 and 16, measured using continuous glucose monitoring. Key secondary end points included HbA1c, adverse events (AEs), and hypoglycemia.


RESULTS Estimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD; n = 54), 66.0% (icodec NLD; n = 50), and 65.0% (IGlar U100; n = 50), with a statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points [95% CI 1.8–13.9%]). Mean HbA1c reduced from 7.9% (62.8 mmol/mol) at baseline to 7.1% (54.4 mmol/mol icodec LD) and 7.4% (57.6 mmol/mol icodec NLD and IGlar U100); incidences and rates of AEs and hypoglycemic episodes were comparable.


CONCLUSIONS Switching from daily basal insulin to once-weekly icodec was well tolerated and provided effective glycemic control. Loading dose use when switching to once-weekly icodec significantly increased percent TIR during weeks 15 and 16 versus once-daily IGlar U100, without increasing hypoglycemia risk.

History

Citation

Diabetes Care 2021 Apr; dc202877. https://doi.org/10.2337/dc20-2877

Author affiliation

Diabetes Research Centre, College of Life Sciences

Version

AM (Accepted Manuscript)

Published in

Diabetes care

Publisher

American Diabetes Association

issn

0149-5992

eissn

1935-5548

Acceptance date

15/02/2021

Copyright date

2021

Available date

27/05/2021

Spatial coverage

United States

Language

eng

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