A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (ONSET 9).


Journal

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

Informations de publication

Date de publication:
08 2020
Historique:
received: 06 11 2019
accepted: 15 02 2020
pubmed: 27 3 2020
medline: 20 2 2021
entrez: 27 3 2020
Statut: ppublish

Résumé

To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp), both with insulin degludec with or without metformin, in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen. This multicenter, double-blind, treat-to-target trial randomized participants to faster aspart ( Noninferiority for the change from baseline in HbA In combination with insulin degludec, faster aspart provided effective overall glycemic control, superior PPG control, and a lower rate of severe or BG-confirmed hypoglycemia versus IAsp in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen.

Identifiants

pubmed: 32209647
pii: dc19-2232
doi: 10.2337/dc19-2232
pmc: PMC7372057
doi:

Substances chimiques

Blood Glucose 0
Drug Combinations 0
Glycated Hemoglobin A 0
Hypoglycemic Agents 0
Insulin, Long-Acting 0
insulin degludec, insulin aspart drug combination 0
insulin degludec 54Q18076QB
Metformin 9100L32L2N
Insulin Aspart D933668QVX

Banques de données

ClinicalTrials.gov
['NCT03268005']

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1710-1716

Informations de copyright

© 2020 by the American Diabetes Association.

Références

Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102
pubmed: 30559235
PLoS One. 2016 Dec 15;11(12):e0168142
pubmed: 27977733
JAMA. 1999 Jun 2;281(21):2005-12
pubmed: 10359389
Diabetes Res Clin Pract. 2007 Aug;77(2):280-5
pubmed: 17240473
Diabetes Care. 2013 May;36(5):1384-95
pubmed: 23589542
Diabetes Care. 2003 Mar;26(3):881-5
pubmed: 12610053
Diabetes Obes Metab. 2019 Sep;21(9):2068-2075
pubmed: 31069935
Diabetes Care. 2017 Jul;40(7):951-957
pubmed: 28483786
Neurology. 2006 Jul 25;67(2):235-40
pubmed: 16864814
Diabetes Care. 2006 Jun;29(6):1214-9
pubmed: 16731998

Auteurs

Wendy S Lane (WS)

Mountain Diabetes and Endocrine Centre, Asheville, NC mountaindiabetes@msn.com.

Elena Favaro (E)

Novo Nordisk A/S, Søborg, Denmark.

Naveen Rathor (N)

Novo Nordisk A/S, Søborg, Denmark.

Hak C Jang (HC)

Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.

Maiken I S Kjærsgaard (MIS)

Novo Nordisk A/S, Aalborg, Denmark.

Alejandra Oviedo (A)

Santojanni Hospital and CENUDIAB, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina.

Ludger Rose (L)

Institute of Diabetes Research, Münster, Germany.

Peter Senior (P)

Division of Endocrinology and Metabolism, University of Alberta, Edmonton, Alberta, Canada.

Giorgio Sesti (G)

Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.

Alfonso Soto Gonzalez (A)

Service of Endocrinology and Nutrition, University Hospital of A Coruña, La Coruña, Spain.

Edward Franek (E)

Mossakowski Clinical Research Center, Polish Academy of Sciences, and Department of Endocrinology and Diabetology, Central Clinical Hospital of the MSWiA, Warsaw, Poland.

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Classifications MeSH