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


Journal

Diabetes care
ISSN: 1935-5548
Titre abrégé: Diabetes Care
Pays: United States
ID NLM: 7805975

Informations de publication

Date de publication:
07 2021
Historique:
received: 25 11 2020
accepted: 15 02 2021
pubmed: 21 4 2021
medline: 15 12 2021
entrez: 20 4 2021
Statut: ppublish

Résumé

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. This was a phase 2, randomized, open-label, 16-week, treat-to-target study. Insulin-naive adults ( 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; 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.

Identifiants

pubmed: 33875484
pii: dc20-2878
doi: 10.2337/dc20-2878
pmc: PMC8323172
doi:

Substances chimiques

Blood Glucose 0
Glycated Hemoglobin A 0
Hypoglycemic Agents 0
Insulin, Long-Acting 0
insulin icodec 0
Insulin Glargine 2ZM8CX04RZ

Banques de données

ClinicalTrials.gov
['NCT03951805']
figshare
['10.2337/figshare.14054921']

Types de publication

Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1595-1603

Subventions

Organisme : NIDDK NIH HHS
ID : P30 DK124723
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002489
Pays : United States

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2021 by the American Diabetes Association.

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Auteurs

Ildiko Lingvay (I)

Endocrinology Division, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX ildiko.lingvay@utsouthwestern.edu.
Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX.

John B Buse (JB)

School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.

Edward Franek (E)

Mossakowski Medical Research Centre, Warsaw, Poland.

Melissa V Hansen (MV)

Novo Nordisk A/S, Søborg, Denmark.

Mette M Koefoed (MM)

Novo Nordisk A/S, Søborg, Denmark.

Chantal Mathieu (C)

Clinical and Experimental Endocrinology, University of Leuven, Leuven, Belgium.

Jeremy Pettus (J)

School of Medicine, University of California, San Diego, San Diego, CA.

Karolina Stachlewska (K)

Novo Nordisk A/S, Søborg, Denmark.

Julio Rosenstock (J)

Dallas Diabetes Research Center at Medical City, Dallas, TX.

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Classifications MeSH