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.
Diabetes Metab Res Rev
; 36(6): e3304, 2020 09.
Article
em En
| MEDLINE
| ID: mdl-32118347
ABSTRACT
AIMS:
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. MATERIALS ANDMETHODS:
ITAS was a multicentre, phase IV, 24-week, open-label, randomized (11), 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 HbA1c . Secondary outcomes included hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs), and adverse events.RESULTS:
Three hundred and fifty five participants were included in the intention-to-treat population. At Week 24, HbA1c reduction from baseline was non-inferior in patient- vs physician-managed arms [least squares mean (LSM) change (SE) -1.60% (0.06) vs -1.49% (0.06), respectively; LSM difference -0.11% (95% CI -0.26 to 0.04)]. The incidence and rates of hypoglycaemia were similarly low in both arms relative risk of confirmed and/or severe nocturnal (0000-0559 hours) hypoglycaemia was 0.77 (95% CI 0.27 to 2.18). No differences were observed for improvement in PROs. No safety concerns were reported.CONCLUSIONS:
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Médicos
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Biomarcadores
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Diabetes Mellitus Tipo 2
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Autogestão
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Hipoglicemia
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Hipoglicemiantes
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Insulina
Tipo de estudo:
Clinical_trials
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Etiology_studies
/
Incidence_studies
/
Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adolescent
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Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article