Switching to Degludec From Other Basal Insulins Is Associated With Reduced Hypoglycemia Rates: A Prospective Study.


Journal

The Journal of clinical endocrinology and metabolism
ISSN: 1945-7197
Titre abrégé: J Clin Endocrinol Metab
Pays: United States
ID NLM: 0375362

Informations de publication

Date de publication:
01 12 2019
Historique:
received: 01 05 2019
accepted: 05 08 2019
pubmed: 10 8 2019
medline: 29 5 2020
entrez: 10 8 2019
Statut: ppublish

Résumé

Observational studies of insulin degludec (degludec) with hypoglycemia events prospectively recorded are lacking. To evaluate the safety and effectiveness of degludec in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) switching from other basal insulins in routine care. Results From Real-World Clinical Treatment With Tresiba® was a multinational, multicenter, prospective, observational, single-arm study comprising a 4-week baseline period (preswitch basal insulin) and 12-month follow-up (degludec). Routine clinical practice. Insulin-treated patients (≥18 years) with T1D (n = 556) or T2D (n = 611) with treatment plans to initiate degludec. Switching to degludec from other basal insulins. Change from baseline in number of overall hypoglycemic events recorded in patient diaries. In T1D, the 12-month follow-up/baseline rate ratios (95% CI) of overall [0.80 (0.74 to 0.88)], nonsevere [0.83 (0.76 to 0.91)], severe [0.28 (0.14 to 0.56)], and nocturnal [0.61 (0.50 to 0.73)] hypoglycemia suggested significantly lower hypoglycemia rates with degludec (all Ps < 0.001). At 12 months, HbA1c, fasting plasma glucose (FPG), and basal insulin dosage decreased significantly. Body weight increased, and treatment satisfaction improved significantly. In T2D, the hypoglycemia rate ratios were overall [0.46 (0.38 to 0.56)], nonsevere [0.53 (0.44 to 0.64)], and nocturnal [0.35 (0.20 to 0.62)] (all Ps < 0.001; too few events for analysis of severe hypoglycemia). At 12 months, HbA1c and FPG decreased significantly. Body weight and insulin dosages remained unchanged, and treatment satisfaction was significantly improved. In a routine clinical care setting, switching to degludec from other basal insulins was associated with significantly lower rates of hypoglycemia, improved glycemic control, and treatment satisfaction in patients with T1D or T2D.

Identifiants

pubmed: 31397845
pii: 5544842
doi: 10.1210/jc.2019-01021
pmc: PMC6812737
doi:

Substances chimiques

Blood Glucose 0
Glycated Hemoglobin A 0
Insulin, Long-Acting 0
Insulins 0
insulin degludec 54Q18076QB

Banques de données

ClinicalTrials.gov
['NCT02392117']

Types de publication

Journal Article Multicenter Study Observational Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

5977-5990

Informations de copyright

Copyright © 2019 Endocrine Society.

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Auteurs

Gian Paolo Fadini (GP)

Department of Medicine, Division of Metabolic Diseases, University of Padova, Padova, Italy.

Michael Feher (M)

Beta Cell Diabetes Centre, Chelsea and Westminster Hospital, London, United Kingdom.
Department of Clinical and Experimental Medicine, University of Surrey, Guildford, United Kingdom.

Troels Krarup Hansen (TK)

Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.

Harold W de Valk (HW)

Department of Internal Medicine, University Medical Center Utrecht, CX Utrecht, Netherlands.

Mette Marie Koefoed (MM)

Novo Nordisk A/S, Søborg, Denmark.

Michael Wolden (M)

Novo Nordisk A/S, Søborg, Denmark.

Esther Zimmermann (E)

Novo Nordisk A/S, Søborg, Denmark.

Johan Jendle (J)

Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Örebro, Sweden.

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Classifications MeSH