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)

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-naive patients with uncontrolled T2DM. MATERIALS AND METHODS: ITAS was a multicentre, phase IV, 24-week, open-label, randomized (1:1), parallel-group study. Insulin-naive 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-naive, 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.