Phillip, M., Mathieu, C., Lind, M. et al. (11 more authors) (2021) Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes: pooled 52‐week outcomes from the DEPICT‐1 and ‐2 studies outcomes from the DEPICT‐1 and ‐2 studies. Diabetes, Obesity and Metabolism, 23 (2). pp. 549-560. ISSN 1462-8902
Abstract
Aim
To evaluate the efficacy and safety of adjunct dapagliflozin therapy in patients with type 1 diabetes (T1D).
Materials and Methods
DEPICT‐1 and ‐2 were randomized, double‐blind, parallel‐group, 24‐week studies, with 28‐week extension periods. Adults with T1D and HbA1c 7.5%‐10.5% were randomized (1:1:1) to receive dapagliflozin 5 mg, 10 mg or placebo. The short‐ and long‐term efficacy and safety of dapagliflozin were examined in an exploratory pooled analysis of both studies.
Results
Efficacy analyses included 530, 529 and 532 and safety analysis included 548, 566 and 532 patients in the dapagliflozin 5 mg, 10 mg and placebo groups, respectively. Baseline characteristics were similar between treatment groups. At week 24, reductions were seen with dapagliflozin 5 and 10 mg compared with placebo in HbA1c (−0.40%, −0.43% vs. 0.00%) and body weight (−2.45, −2.91 vs. 0.11 kg). HbA1c and body weight reductions versus placebo were also seen after 52 weeks of treatment. There was no imbalance in occurrence of severe hypoglycaemic events between groups. The proportion of patients experiencing definite diabetic ketoacidosis (DKA) was higher with dapagliflozin 5 mg (4.0%) and 10 mg (3.5%) compared with placebo (1.1%) over 52 weeks; most events were of mild or moderate severity, and all resolved with treatment.
Conclusions
Over 52 weeks, dapagliflozin provided glycaemic and weight benefits, with no increased frequency of severe hypoglycaemia compared with placebo. More DKA events were reported with dapagliflozin than placebo, highlighting the importance of appropriate patient selection, education and risk‐mitigation strategies.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2020 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, (http://creativecommons.org/licenses/by-nc/4.0/) which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
Keywords: | dapagliflozin; DEPICT; DKA; insulin adjunct; long‐term data; severe hypoglycaemia; SGLT‐2 inhibitor; T1D |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Human Metabolism (Sheffield) The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Oncology (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 28 Jan 2021 16:00 |
Last Modified: | 28 Jan 2021 16:00 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1111/dom.14248 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:169674 |