Switching to Degludec From Other Basal Insulins Is Associated With Reduced Hypoglycemia Rates: A Prospective Study.
Adult
Aged
Blood Glucose
/ drug effects
Diabetes Mellitus, Type 1
/ blood
Diabetes Mellitus, Type 2
/ blood
Drug Substitution
/ statistics & numerical data
Europe
/ epidemiology
Female
Follow-Up Studies
Glycated Hemoglobin
/ drug effects
Humans
Hypoglycemia
/ chemically induced
Insulin, Long-Acting
/ therapeutic use
Insulins
/ therapeutic use
Male
Middle Aged
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
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
5977-5990Informations de copyright
Copyright © 2019 Endocrine Society.
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