Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2020 Apr;22(4):540-548.
doi: 10.1111/dom.13922. Epub 2019 Dec 26.

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

Eiichi Araki  1 , Hirotaka Watada  2 , Yasuko Uchigata  3 , Osamu Tomonaga  4 , Hitomi Fujii  5 , Hiroshi Ohashi  6 , Tadashi Okabe  7 , Michiko Asano  8 , Fredrik Thoren  9 , Hyosung Kim  8 , Toshitaka Yajima  8 , Anna Maria Langkilde  9
Affiliations
Clinical Trial

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

Eiichi Araki et al. Diabetes Obes Metab. 2020 Apr.

Abstract

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) <25.0 and ≥25.0 kg/m2 was evaluated in a subgroup analysis.

Results: In total, 151 patients received 5 mg (n = 76) or 10 mg (n = 75) dapagliflozin once daily for 52 weeks. Adverse events were observed in 88.2% and 73.3% of patients in the 5 and 10 mg dapagliflozin groups, respectively. Severe hypoglycaemia was reported in 2.6% (n = 2) and 6.7% (n = 5) of patients, and diabetic ketoacidosis in 2.6% (n = 2) and 1.3% (n = 1) of patients in the 5 and 10 mg dapagliflozin groups, respectively. The adjusted mean (95% confidence interval) changes in glycated haemoglobin at week 52 were -0.33% (-0.50, -0.15) and -0.36% (-0.53, -0.18) in the 5 and 10 mg dapagliflozin groups, respectively. There were no differences in efficacy parameters when stratified by BMI.

Conclusions: This study demonstrated the long-term safety and tolerability of dapagliflozin added to insulin therapy in Japanese patients with inadequately controlled T1DM.

PubMed Disclaimer

Conflict of interest statement

E.A. has participated on advisory panels for Alcon, Astellas Pharma, AstraZeneca, Eli Lilly, Kowa Pharmaceutical, Nippon Boehringer Ingelheim, Novo Nordisk Pharma, Sanofi, and Terumo Corporation; has received honoraria for lectures from Astellas Pharma, MSD, Ono Pharmaceutical, Novo Nordisk Pharma, and Sanofi; and has received scholarship grants from Astellas Pharma, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Novo Nordisk Pharma, Ono Pharmaceutical, Sanofi, Shionogi, Sumitomo Dainippon Pharma, and Takeda Pharmaceutical. H.W. reports acting as an advisory board member for Novo Nordisk and as a speaker for Astellas Pharma, Sanofi, Mitsubishi Tanabe Pharma, Novo Nordisk, Kowa Pharmaceutical, AstraZeneca, Takeda Pharmaceutical, Novartis, Nippon Boehringer Ingelheim, Merck Sharp & Dohme, Sumitomo Dainippon Pharma, Eli Lilly Japan, Sanwa Kagaku Kenkyusho, Ono Pharmaceutical, Kissei Pharmaceutical, and FUJIFILM Pharma; and receiving grants from Astellas Pharma, Sanofi, Mitsubishi Tanabe Pharma, Novo Nordisk Pharma, AstraZeneca, Takeda Pharmaceutical, Novartis Pharma, Nippon Boehringer Ingelheim, Merck Sharp & Dohme, Sumitomo Dainippon Pharma, Eli Lilly Japan, Ono Pharmaceutical, Kyowa Kirin, Daiichi Sankyo, Terumo, Pfizer Japan, Mochida Pharmaceutical, Taisho Toyama Pharmaceutical, Johnson & Johnson, and Kowa. Y.U. has received grants and honoraria from AstraZeneca K.K. and holds a position as a board member for AstraZeneca K.K. O.T., H.F., H.O. and T.O. have no conflict of interest to disclose. F.T. and A.M.L. are employees of AstraZeneca. M.A., H.K. and T.Y. are employees of AstraZeneca K.K.

Figures

Figure 1
Figure 1
Study design. Abbreviation: T1DM, type 1 diabetes mellitus
Figure 2
Figure 2
Mean change from baseline in the following. A, HbA1c. B, Total daily insulin dose. C, Body weight. Error bars represent 95% confidence intervals for the adjusted mean change from baseline. Abbreviation: HbA1c, glycated haemoglobin
See this image and copyright information in PMC

References

    1. Chiang JL, Kirkman MS, Laffel LMB, Peters AL; Type 1 Diabetes Sourcebook Authors. Type 1 diabetes through the life span: A position statement of the American Diabetes Association. Diabetes Care. 2014;37:2034‐2054. - PMC - PubMed
    1. Conway B, Miller RG, Costacou T, et al. Temporal patterns in overweight and obesity in Type 1 diabetes. Diabet Med. 2010;27:398‐404. - PMC - PubMed
    1. Szadkowska A, Madej A, Ziolkowska K, et al. Gender and age‐dependent effect of type 1 diabetes on obesity and altered body composition in young adults. Ann Agric Environ Med. 2015;22:124‐128. - PubMed
    1. Emerging Risk Factors Collaboration, Sarwar N, Gao P, et al. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta‐analysis of 102 prospective studies. Lancet. 2010;375:2215‐2222. - PMC - PubMed
    1. Rao Kondapally Seshasai S, Kaptoge S, Thompson A, et al. Diabetes mellitus, fasting glucose, and risk of cause‐specific death. N Engl J Med. 2011;364:829‐841. - PMC - PubMed

Publication types