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 (ITAS)

Andrea Giaccari, Riccardo C. Bonadonna, Raffaella Buzzetti, Gianluca Perseghin, Domenico Cucinotta, Angelo Avogaro, Gianluca Aimaretti, Monica Larosa, Carmine G. Fanelli, Geremia B. Bolli

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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 AND METHODS: 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 HbA1c . Secondary outcomes included hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs) and adverse events. RESULTS: 355 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 (00.00-05.59 h) 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. This article is protected by copyright. All rights reserved.
Original languageEnglish
Pages (from-to)e3304-e3309
JournalDiabetes/Metabolism Research and Reviews
DOIs
Publication statusPublished - 2020

Keywords

  • glargine 300 U/mL
  • glycaemic control
  • hypoglycaemia
  • insulin analogues
  • personalized medicine
  • randomised trial
  • type 2 diabetes

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