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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 (Gla-300) in Patients with Uncontrolled Type 2 Diabetes

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posted on 2019-04-17, 12:58 authored by D Russell-Jones, A Dauchy, E Delgado, G Dimitriadis, HA Frandsen, L Popescu, B Schultes, K Strojek, M Bonnemaire, AR de Climens, M Davies
Aim To compare the efficacy and safety of self‐ vs physician‐managed titration of insulin glargine 300 U/mL (Gla‐300), in patients with inadequately controlled type 2 diabetes. Methods Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multinational, open‐label, controlled, 2‐arm, parallel‐group study in insulin‐naïve and pre‐treated patients, randomized 1:1 to a self‐ or physician‐managed titration of Gla‐300. The fasting self‐monitored plasma glucose (SMPG) target was 4.4–7.2 mmol/L. The primary outcome was non‐inferiority of HbA1c change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and patient‐reported outcomes (PROs). Results At week 24, the least squares (LS) mean HbA1c reduction was 0.97 % and 0.84 % in the self‐ and physician‐managed groups, respectively, with an LS mean difference of −0.13 % [95% CI: −0.2619 to −0.0004] 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.

Funding

This work was supported by Sanofi, Paris, France. Editorial assistance was provided by Arthur Holland, PhD, of Fishawack Communications, and was funded by Sanofi.

History

Citation

Diabetes, Obesity and Metabolism, 2019

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Diabetes Research Centre

Version

  • AM (Accepted Manuscript)

Published in

Diabetes

Publisher

Wiley

issn

1462-8902

Acceptance date

2019-03-06

Copyright date

2019

Publisher version

https://onlinelibrary.wiley.com/doi/abs/10.1111/dom.13697

Notes

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com.;The file associated with this record is under embargo until 12 months after publication, in accordance with the publisher's self-archiving policy. The full text may be available through the publisher links provided above.

Language

en

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