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Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes

AIM: To compare the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL (Gla‐300) in people with inadequately controlled type 2 diabetes. METHODS: Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multi‐national, open‐label, controlled, two‐arm, pa...

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Autores principales: Russell‐Jones, David, Dauchy, Arnaud, Delgado, Elías, Dimitriadis, George, Frandsen, Hans A., Popescu, Luiza, Schultes, Bernd, Strojek, Krzysztof, Bonnemaire, Mireille, Roborel de Climens, Aude, Davies, Melanie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6767413/
https://www.ncbi.nlm.nih.gov/pubmed/30851006
http://dx.doi.org/10.1111/dom.13697
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author Russell‐Jones, David
Dauchy, Arnaud
Delgado, Elías
Dimitriadis, George
Frandsen, Hans A.
Popescu, Luiza
Schultes, Bernd
Strojek, Krzysztof
Bonnemaire, Mireille
Roborel de Climens, Aude
Davies, Melanie
author_facet Russell‐Jones, David
Dauchy, Arnaud
Delgado, Elías
Dimitriadis, George
Frandsen, Hans A.
Popescu, Luiza
Schultes, Bernd
Strojek, Krzysztof
Bonnemaire, Mireille
Roborel de Climens, Aude
Davies, Melanie
author_sort Russell‐Jones, David
collection PubMed
description AIM: To compare the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL (Gla‐300) in people with inadequately controlled type 2 diabetes. METHODS: Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multi‐national, open‐label, controlled, two‐arm, parallel‐group study in insulin‐naïve and pre‐treated participants, randomized 1:1 to a self‐ or physician‐managed titration of Gla‐300. The fasting self‐monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non‐inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant‐reported outcomes (PROs). RESULTS: At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self‐ and physician‐managed groups, respectively, with an LS mean difference of −0.13% [95% confidence interval −0.2619 to −0.0004] (–1.4 mmol/mol [–2.863 to –0.004]), demonstrating non‐inferiority (P < 0.0001) and superiority (P = 0.0247) of self‐ versus physician‐managed titration. Significantly more of the self‐ than physician‐managed group achieved SMPG target without hypoglycaemia (67% vs 58%; P = 0.0187). Overall, hypoglycaemia incidence was similar in each group. No safety concerns were reported. In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self‐management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self‐managed group. CONCLUSIONS: Self‐managed titration of Gla‐300 was superior to physician‐managed titration in terms of HbA1c reduction, accompanied by similar total PRO scores, with a clinically relevant reduction in emotional burden, and similar hypoglycaemia frequency.
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spelling pubmed-67674132019-10-03 Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes Russell‐Jones, David Dauchy, Arnaud Delgado, Elías Dimitriadis, George Frandsen, Hans A. Popescu, Luiza Schultes, Bernd Strojek, Krzysztof Bonnemaire, Mireille Roborel de Climens, Aude Davies, Melanie Diabetes Obes Metab Original Articles AIM: To compare the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL (Gla‐300) in people with inadequately controlled type 2 diabetes. METHODS: Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multi‐national, open‐label, controlled, two‐arm, parallel‐group study in insulin‐naïve and pre‐treated participants, randomized 1:1 to a self‐ or physician‐managed titration of Gla‐300. The fasting self‐monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non‐inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant‐reported outcomes (PROs). RESULTS: At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self‐ and physician‐managed groups, respectively, with an LS mean difference of −0.13% [95% confidence interval −0.2619 to −0.0004] (–1.4 mmol/mol [–2.863 to –0.004]), demonstrating non‐inferiority (P < 0.0001) and superiority (P = 0.0247) of self‐ versus physician‐managed titration. Significantly more of the self‐ than physician‐managed group achieved SMPG target without hypoglycaemia (67% vs 58%; P = 0.0187). Overall, hypoglycaemia incidence was similar in each group. No safety concerns were reported. In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self‐management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self‐managed group. CONCLUSIONS: Self‐managed titration of Gla‐300 was superior to physician‐managed titration in terms of HbA1c reduction, accompanied by similar total PRO scores, with a clinically relevant reduction in emotional burden, and similar hypoglycaemia frequency. Blackwell Publishing Ltd 2019-04-30 2019-07 /pmc/articles/PMC6767413/ /pubmed/30851006 http://dx.doi.org/10.1111/dom.13697 Text en © 2019 The Authors. Diabetes, Obesity and Metabolism 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 Original Articles
Russell‐Jones, David
Dauchy, Arnaud
Delgado, Elías
Dimitriadis, George
Frandsen, Hans A.
Popescu, Luiza
Schultes, Bernd
Strojek, Krzysztof
Bonnemaire, Mireille
Roborel de Climens, Aude
Davies, Melanie
Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes
title Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes
title_full Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes
title_fullStr Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes
title_full_unstemmed Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes
title_short Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes
title_sort take control: a randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 u/ml in patients with uncontrolled type 2 diabetes
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6767413/
https://www.ncbi.nlm.nih.gov/pubmed/30851006
http://dx.doi.org/10.1111/dom.13697
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