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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
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 u...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7540052/ https://www.ncbi.nlm.nih.gov/pubmed/32118347 http://dx.doi.org/10.1002/dmrr.3304 |
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author | Bonadonna, Riccardo C. Giaccari, Andrea Buzzetti, Raffaella Perseghin, Gianluca Cucinotta, Domenico Avogaro, Angelo Aimaretti, Gianluca Larosa, Monica Fanelli, Carmine G. Bolli, Geremia B. |
author_facet | Bonadonna, Riccardo C. Giaccari, Andrea Buzzetti, Raffaella Perseghin, Gianluca Cucinotta, Domenico Avogaro, Angelo Aimaretti, Gianluca Larosa, Monica Fanelli, Carmine G. Bolli, Geremia B. |
author_sort | Bonadonna, Riccardo C. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7540052 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-75400522020-10-09 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 Bonadonna, Riccardo C. Giaccari, Andrea Buzzetti, Raffaella Perseghin, Gianluca Cucinotta, Domenico Avogaro, Angelo Aimaretti, Gianluca Larosa, Monica Fanelli, Carmine G. Bolli, Geremia B. Diabetes Metab Res Rev Research Articles 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. John Wiley & Sons, Inc. 2020-04-05 2020-09 /pmc/articles/PMC7540052/ /pubmed/32118347 http://dx.doi.org/10.1002/dmrr.3304 Text en © 2020 SANOFI. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Articles Bonadonna, Riccardo C. Giaccari, Andrea Buzzetti, Raffaella Perseghin, Gianluca Cucinotta, Domenico Avogaro, Angelo Aimaretti, Gianluca Larosa, Monica Fanelli, Carmine G. Bolli, Geremia B. 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7540052/ https://www.ncbi.nlm.nih.gov/pubmed/32118347 http://dx.doi.org/10.1002/dmrr.3304 |
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