Comparable efficacy with similarly low risk of hypoglycaemia in patient- vs physician-managed basal insulin initiation and titration in insulin-naïve type 2 diabetic subjects: The Italian Titration Approach Study.
Adolescent
Adult
Aged
Aged, 80 and over
Biomarkers
/ analysis
Blood Glucose
/ analysis
Diabetes Mellitus, Type 2
/ drug therapy
Female
Follow-Up Studies
Glycated Hemoglobin
/ analysis
Glycemic Control
Humans
Hypoglycemia
/ chemically induced
Hypoglycemic Agents
/ administration & dosage
Incidence
Insulin
/ administration & dosage
Italy
/ epidemiology
Male
Middle Aged
Physician-Patient Relations
Physicians
/ statistics & numerical data
Prognosis
Self-Management
/ methods
Young Adult
glargine 300 U/mL
glycaemic control
hypoglycaemia
insulin analogues
personalized medicine
randomized trial
type 2 diabetes
Journal
Diabetes/metabolism research and reviews
ISSN: 1520-7560
Titre abrégé: Diabetes Metab Res Rev
Pays: England
ID NLM: 100883450
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
16
07
2019
revised:
09
12
2019
accepted:
24
02
2020
pubmed:
3
3
2020
medline:
18
8
2021
entrez:
3
3
2020
Statut:
ppublish
Résumé
People with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin. Patient-managed titration may reduce such deferral. The Italian Titration Approach Study (ITAS) compared the efficacy and safety of insulin glargine 300 U/mL (Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin-naïve patients with uncontrolled T2DM. ITAS was a multicentre, phase IV, 24-week, open-label, randomized (1:1), parallel-group study. Insulin-naïve adults with T2DM for ≥1 year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides, and were randomized to self-titrate insulin dose (nurse-assisted) or have it done by the physician. The primary endpoint was change in HbA Three hundred and fifty five participants were included in the intention-to-treat population. At Week 24, HbA In the T2DM insulin-naïve, SU/glinides discontinued population, patient-managed (nurse-assisted) titration of Gla-300 may be a suitable option as it provides improved glycaemic control with low risk of hypoglycaemia, similar to physician-managed titration.
Identifiants
pubmed: 32118347
doi: 10.1002/dmrr.3304
pmc: PMC7540052
doi:
Substances chimiques
Biomarkers
0
Blood Glucose
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin
0
hemoglobin A1c protein, human
0
Types de publication
Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e3304Subventions
Organisme : Sanofi, Milan, Italy
Pays : International
Informations de copyright
© 2020 SANOFI. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.
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