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Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial

AIM: To investigate the long‐term efficacy and safety of dapagliflozin as an adjunct to adjustable insulin in adults with type 1 diabetes (T1D) and inadequate glycaemic control. MATERIALS AND METHODS: Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT‐2) was a...

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Autores principales: Mathieu, Chantal, Rudofsky, Gottfried, Phillip, Moshe, Araki, Eiichi, Lind, Marcus, Arya, Niki, Thorén, Fredrik, Scheerer, Markus F., Iqbal, Nayyar, Dandona, Paresh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496089/
https://www.ncbi.nlm.nih.gov/pubmed/32311204
http://dx.doi.org/10.1111/dom.14060
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author Mathieu, Chantal
Rudofsky, Gottfried
Phillip, Moshe
Araki, Eiichi
Lind, Marcus
Arya, Niki
Thorén, Fredrik
Scheerer, Markus F.
Iqbal, Nayyar
Dandona, Paresh
author_facet Mathieu, Chantal
Rudofsky, Gottfried
Phillip, Moshe
Araki, Eiichi
Lind, Marcus
Arya, Niki
Thorén, Fredrik
Scheerer, Markus F.
Iqbal, Nayyar
Dandona, Paresh
author_sort Mathieu, Chantal
collection PubMed
description AIM: To investigate the long‐term efficacy and safety of dapagliflozin as an adjunct to adjustable insulin in adults with type 1 diabetes (T1D) and inadequate glycaemic control. MATERIALS AND METHODS: Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT‐2) was a placebo‐controlled, double‐blind, multicentre, phase III study of adults with T1D (HbA1c 7.5%‐10.5%) randomized (1:1:1) to receive dapagliflozin 5, 10 mg, or placebo. The efficacy and safety of dapagliflozin over 52 weeks were exploratory endpoints in this extension to DEPICT‐2. RESULTS: Of 813 participants randomized, 88.2% completed the study. From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA1c (difference [95% CI] vs. placebo: −0.20% [−0.34, −0.06] and −0.25% [−0.38, −0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: −4.42% [−5.19, −3.64] and −4.86% [−5.63, −4.08], respectively). Serious adverse events were reported in the dapagliflozin 5, 10 mg, and placebo groups (32 [11.8%], 19 [7.0%] and 16 [5.9%], respectively). The proportion of hypoglycaemic events was similar across groups; severe hypoglycaemia was uncommon. More participants with events adjudicated as definite diabetic ketoacidosis (DKA) were in the dapagliflozin 5 and 10 mg groups versus placebo (11 [4.1%], 10 [3.7%] and 1 [0.4%], respectively); the majority of events were mild or moderate in severity and all were resolved with treatment. CONCLUSIONS: Dapagliflozin led to long‐term reductions in HbA1c and body weight in adults with T1D, but increased DKA risk compared with placebo.
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spelling pubmed-74960892020-09-25 Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial Mathieu, Chantal Rudofsky, Gottfried Phillip, Moshe Araki, Eiichi Lind, Marcus Arya, Niki Thorén, Fredrik Scheerer, Markus F. Iqbal, Nayyar Dandona, Paresh Diabetes Obes Metab Original Articles AIM: To investigate the long‐term efficacy and safety of dapagliflozin as an adjunct to adjustable insulin in adults with type 1 diabetes (T1D) and inadequate glycaemic control. MATERIALS AND METHODS: Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT‐2) was a placebo‐controlled, double‐blind, multicentre, phase III study of adults with T1D (HbA1c 7.5%‐10.5%) randomized (1:1:1) to receive dapagliflozin 5, 10 mg, or placebo. The efficacy and safety of dapagliflozin over 52 weeks were exploratory endpoints in this extension to DEPICT‐2. RESULTS: Of 813 participants randomized, 88.2% completed the study. From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA1c (difference [95% CI] vs. placebo: −0.20% [−0.34, −0.06] and −0.25% [−0.38, −0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: −4.42% [−5.19, −3.64] and −4.86% [−5.63, −4.08], respectively). Serious adverse events were reported in the dapagliflozin 5, 10 mg, and placebo groups (32 [11.8%], 19 [7.0%] and 16 [5.9%], respectively). The proportion of hypoglycaemic events was similar across groups; severe hypoglycaemia was uncommon. More participants with events adjudicated as definite diabetic ketoacidosis (DKA) were in the dapagliflozin 5 and 10 mg groups versus placebo (11 [4.1%], 10 [3.7%] and 1 [0.4%], respectively); the majority of events were mild or moderate in severity and all were resolved with treatment. CONCLUSIONS: Dapagliflozin led to long‐term reductions in HbA1c and body weight in adults with T1D, but increased DKA risk compared with placebo. Blackwell Publishing Ltd 2020-05-22 2020-09 /pmc/articles/PMC7496089/ /pubmed/32311204 http://dx.doi.org/10.1111/dom.14060 Text en © 2020 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-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Mathieu, Chantal
Rudofsky, Gottfried
Phillip, Moshe
Araki, Eiichi
Lind, Marcus
Arya, Niki
Thorén, Fredrik
Scheerer, Markus F.
Iqbal, Nayyar
Dandona, Paresh
Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial
title Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial
title_full Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial
title_fullStr Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial
title_full_unstemmed Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial
title_short Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial
title_sort long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the depict‐2 study): 52‐week results from a randomized controlled trial
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496089/
https://www.ncbi.nlm.nih.gov/pubmed/32311204
http://dx.doi.org/10.1111/dom.14060
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