Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial

Aims To investigate the safety and tolerability of 5 and 10 mg dapagliflozin added to insulin therapy over 52 weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM). Materials and methods This randomized, open‐label, parallel‐group, multicentre phase III clinical tri...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2020-04, Vol.22 (4), p.540-548
Main Authors: Araki, Eiichi, Watada, Hirotaka, Uchigata, Yasuko, Tomonaga, Osamu, Fujii, Hitomi, Ohashi, Hiroshi, Okabe, Tadashi, Asano, Michiko, Thoren, Fredrik, Kim, Hyosung, Yajima, Toshitaka, Langkilde, Anna Maria
Format: Article
Language:English
Subjects:
Antidiabetics
Body mass index
Body weight
Clinical trials
Diabetes
Diabetes mellitus (insulin dependent)
Hemoglobin
Hypoglycemia
Insulin
Ketoacidosis
Obesity
Original
Safety
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Summary:Aims To investigate the safety and tolerability of 5 and 10 mg dapagliflozin added to insulin therapy over 52 weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM). Materials and methods This randomized, open‐label, parallel‐group, multicentre phase III clinical trial was conducted from October 26, 2015 to June 15, 2017. The primary endpoint was the occurrence of adverse events such as hypoglycaemia and diabetic ketoacidosis. Secondary endpoints included changes in glycaemic parameters, total daily insulin dosage and body weight over time. The efficacy of dapagliflozin in patients stratified by body mass index (BMI)
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.13922