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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
Author(s) -
Bonadonna Riccardo C.,
Giaccari Andrea,
Buzzetti Raffaella,
Perseghin Gianluca,
Cucinotta Domenico,
Avogaro Angelo,
Aimaretti Gianluca,
Larosa Monica,
Fanelli Carmine G.,
Bolli Geremia B.
Publication year - 2020
Publication title -
diabetes/metabolism research and reviews
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.307
H-Index - 110
eISSN - 1520-7560
pISSN - 1520-7552
DOI - 10.1002/dmrr.3304
Subject(s) - medicine , insulin glargine , discontinuation , type 2 diabetes , insulin , diabetes mellitus , population , adverse effect , clinical endpoint , incidence (geometry) , hypoglycemia , randomized controlled trial , endocrinology , physics , environmental health , optics
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 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 HbA 1c . 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, HbA 1c 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 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.