Italian Titration Approach Study (ITAS) with insulin glargine 300 U/mL in insulin-naïve type 2 diabetes: Design and population.
Aged
Biomarkers
/ blood
Blood Glucose
/ drug effects
Diabetes Mellitus, Type 2
/ blood
Female
Glycated Hemoglobin
/ metabolism
Humans
Hypoglycemic Agents
/ administration & dosage
Insulin Glargine
/ administration & dosage
Italy
Male
Middle Aged
Nurse's Role
Patient Participation
Physician's Role
Self Care
Time Factors
Treatment Outcome
Insulin glargine 300 U/mL
Insulin titration
Patient empowerment
Type 2 diabetes
Journal
Nutrition, metabolism, and cardiovascular diseases : NMCD
ISSN: 1590-3729
Titre abrégé: Nutr Metab Cardiovasc Dis
Pays: Netherlands
ID NLM: 9111474
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
15
09
2018
revised:
03
01
2019
accepted:
17
01
2019
pubmed:
7
4
2019
medline:
20
12
2019
entrez:
7
4
2019
Statut:
ppublish
Résumé
Fostering patient's self-managing of basal insulin therapy could improve glucose control, by removing patient's and physician's barriers to basal insulin initiation, titration and glucose monitoring. The Italian Titration Approaches Study (ITAS) aims at demonstrating non-inferiority (<0.3% margin) in efficacy of glucose control (change in glycated hemoglobin [HbA1c] after 24 weeks) by the same titration algorithm of insulin glargine 300 U/mL (Gla-300), managed by the (nurse assisted) patient versus the physician, in insulin naïve patients with Type 2 Diabetes Mellitus (T2DM), uncontrolled with previous treatments. ITAS is a phase IV, 24-week, national, multicenter, open label, randomized (1:1) parallel group study. 458 patients were enrolled, 359 randomized, and 339 completed the study, in 46 Italian centers. Baseline characteristics and previous medications of the ITT population (N = 355) are reported. Mean ± SD age, T2DM duration, HbA1c, FPG and BMI were 64.0 ± 9.8 years, 11.6 ± 7.6 years, 8.79 ± 0.65%, 170.9 ± 42.3 mg/dL, and 30.3 ± 5.6 kg/m ITAS is the first study to compare two different managers (nurse-assisted patient vs physician) of the same titration algorithm of Gla-300 in insulin naïve patients with T2DM in unsatisfactory glucose control. This study might provide novel evidence on the efficacy/effectiveness of patient-managed titration algorithm of Gla-300 in a pragmatic setting and may reduce barriers to basal insulin initiation and its titration.
Sections du résumé
BACKGROUND AND AIMS
Fostering patient's self-managing of basal insulin therapy could improve glucose control, by removing patient's and physician's barriers to basal insulin initiation, titration and glucose monitoring. The Italian Titration Approaches Study (ITAS) aims at demonstrating non-inferiority (<0.3% margin) in efficacy of glucose control (change in glycated hemoglobin [HbA1c] after 24 weeks) by the same titration algorithm of insulin glargine 300 U/mL (Gla-300), managed by the (nurse assisted) patient versus the physician, in insulin naïve patients with Type 2 Diabetes Mellitus (T2DM), uncontrolled with previous treatments.
METHODS AND RESULTS
ITAS is a phase IV, 24-week, national, multicenter, open label, randomized (1:1) parallel group study. 458 patients were enrolled, 359 randomized, and 339 completed the study, in 46 Italian centers. Baseline characteristics and previous medications of the ITT population (N = 355) are reported. Mean ± SD age, T2DM duration, HbA1c, FPG and BMI were 64.0 ± 9.8 years, 11.6 ± 7.6 years, 8.79 ± 0.65%, 170.9 ± 42.3 mg/dL, and 30.3 ± 5.6 kg/m
CONCLUSION
ITAS is the first study to compare two different managers (nurse-assisted patient vs physician) of the same titration algorithm of Gla-300 in insulin naïve patients with T2DM in unsatisfactory glucose control. This study might provide novel evidence on the efficacy/effectiveness of patient-managed titration algorithm of Gla-300 in a pragmatic setting and may reduce barriers to basal insulin initiation and its titration.
Identifiants
pubmed: 30952575
pii: S0939-4753(19)30028-6
doi: 10.1016/j.numecd.2019.01.011
pii:
doi:
Substances chimiques
Biomarkers
0
Blood Glucose
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
hemoglobin A1c protein, human
0
Insulin Glargine
2ZM8CX04RZ
Types de publication
Clinical Trial, Phase IV
Comparative Study
Equivalence Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
496-503Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright © 2019. Published by Elsevier B.V.