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Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized Controlled Trial

Mathieu, Chantal, Dandona, Paresh, Gillard, Pieter, Senior, Peter, Hasslacher, Christoph, Araki, Eiichi, Lind, Marcus, Bain, Stephen C. +155 more·2018·Diabetes Care
DOI 10.2337/dc18-0623
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Abstract

Objective This 24-week, double-blinded, phase 3 clinical trial (DEPICT-2; ClinicalTrials.gov, NCT02460978) evaluated efficacy and safety of dapagliflozin as adjunct therapy to adjustable insulin in patients with inadequately controlled type 1 diabetes (HbA 1c 7.5-10.5%). Research design and methods Patients were randomized 1:1:1 to dapagliflozin 5 mg ( n = 271), dapagliflozin 10 mg ( n = 270), or placebo ( n = 272) plus insulin. Insulin dose was adjusted by investigators according to self-monitored glucose readings, local guidance, and individual circumstances. Results Baseline characteristics were balanced between treatment groups. At week 24, dapagliflozin significantly decreased HbA 1c (primary outcome; difference vs. placebo: dapagliflozin 5 mg -0.37% [95% CI -0.49, -0.26], dapagliflozin 10 mg -0.42% [-0.53, -0.30]), total daily insulin dose (-10.78% [-13.73, -7.72] and -11.08% [-14.04, -8.02], respectively), and body weight (-3.21% [-3.96, -2.45] and -3.74% [-4.49, -2.99], respectively) ( P 70 to ≤180 mg/dL) versus placebo were significantly improved. More patients receiving dapagliflozin achieved a reduction in HbA 1c ≥0.5% without severe hypoglycemia compared with placebo. Adverse events were reported for 72.7%, 67.0%, and 63.2% of patients receiving dapagliflozin 5 mg, dapagliflozin 10 mg, and placebo, respectively. Hypoglycemia, including severe hypoglycemia, was balanced between groups. There were more adjudicated definite diabetic ketoacidosis (DKA) events with dap…

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  • Use of preventative processes may have contributed to the lower rates of ketoacidosis seen in some studies of SGLT inhibitors for adjunctive glycemic management in type 1 diabetes compared with those that did not include preventative strategies.

    “Use of these processes may have contributed to the lower rates of ketoacidosis seen in some of the studies of these agents for adjunctive glycemic management in people with type 1 diabetes (314-316) compared with those that did not include preventative strategies (310,317).”

    From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [315]

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Authors
Mathieu, C., Dandona, P., Gillard, P., Senior, P., Hasslacher, C., Araki, E., Lind, M., Bain, S. C., Jabbour, S., Arya, N., Hansen, L., Thorén, F., Langkilde, A. M., DEPICT-2 Investigators, Luquez, C., Manghi, F. P., Ulla, M. R., Moisello, M. A., Visco, V., De Lapertoza, S. G., Solis, S. E., Farias, J., Sposetti, G., Gillard, P., Abrams, P., van Ypersele de Strihou, M., Conway, J., Pedersen, S., Senior, P., Liutkus, J. F., Yip, C.-E., Punthakee, Z., Bernier, F., Lochnan, H., Woo, V., Elliott, T., Palma, J., Merino, C. S., Vargas, A. D., Wendisch, U., Reichel, A., Seufert, J., Becker, B., Alawi, H., Birkenfeld, A. L., Hasslacher, C., Luedemann, J., Schaum, T., Marck, C., Sauter, J., Aigner, U., Onishi, Y., Seino, H., Sato, Y., Nunoi, K., Yamauchi, A., Nakashima, E., Ikeda, H., Shiraiwa, T., Yamasaki, Y., Yokoyama, H., Nakamura, K., Noritake, M., Miyauchi, S., Hakoda, T., Hirohata, Y., Hasegawa, A., Fukumoto, Y., Nagashima, H., Takihata, M., Kamada, T., Jinnouchi, H., Ono, Y., Watanabe, T., Ohashi, H., Takai, M., Seguchi, T., Yamazaki, K., Maeda, H., Iwasaki, S., De Valk, H. W., Kooy, A., Landewe-Cleuren, S., Madziarska, K., Stankiewicz, A., Wasilewska, K., Rudofsky, G., Malecki, M., Pankowska, E., Szyprowska, E., Lukaszewicz, M., Tokarska, L., Bondar, I., Karpova, I., Ruyatkina, L., Zalevskaya, A., Sardinov, R., Khalimov, Y., Sjoberg, F., Koskinen, P., Curiac, D., Lind, M., Bach-Kliegel, B., Schultes, B., Issa, B. G., Kilvert, A., Pereira, O., Bain, S., Mishra, B., Bhatnagar, D., Chuck, L., Gorson, D., Robertson, D., Casaubon, L., Chaykin, L., Frias, J. P., Hsia, S., Jenders, R., Lerman, S., Segel, S., Weissman, P., Chang, A., Reed, J., Madu, I.-J., Bressler, P., Abbott, L., Gangi, S., Wheeler, K., Cohen, K., Biggs, W., Jabbour, S., Karounos, D., Menon, S., Miers, W., Aleppo, G., Lefebvre, G., Sugimoto, D., Ferraro, R., Kelly, R., Twahirwa, M., Case, C., Klonoff, D., Denker, P., Hollander, P., Welch, M., Leinung, M., Kotek, L., McGill, J., Shlesinger, Y., Huffman, C., Aronoff, S., Lorber, D., Terrelonge, A., Akhrass, F., Bredefeld, C., Hershon, K., Lenhard, J., Donovan, D., Stonesifer, L., Greenberg, C., Ipp, E., Bhargava, A., & Bao, S.
Affiliations
  • KU Leuven (BE)
  • University at Buffalo, State University of New York (US)
  • Kumamoto University (JP)
  • Diabetes Research Unit, Swansea University, Swansea, Wales, U.K.
  • AstraZeneca (United States) (US)
  • MedImmune, Gaithersburg, MD
  • AstraZeneca, Gothenburg, Sweden
  • AstraZeneca (Sweden) (SE)
  • University of Alberta (CA)
  • Diabetesinstitut Heidelberg (DE)
  • NU Hospital Group (SE)
  • Swansea University (GB)
  • Thomas Jefferson University (US)
Corresponding author
Mathieu, Chantal
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2018-07-19
Volume
41
Issue
9
Pages
1938-1946
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc18-0623
OpenAlex
W2884380775
Cited by
252
References
23
Citations by year
2026: 10 · 2025: 27 · 2024: 19 · 2023: 25 · 2022: 25 · 2021: 27 · 2020: 52 · 2019: 55 · 2018: 11 · 2017: 1
FWCI
29.05
Type
journal article
Language
en
Open access
closed
Licence
www.diabetesjournals.org/content/license (vor, 34 d)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
  • Lirias (submittedVersion)
  • VUBIR (Vrije Universiteit Brussel) (submittedVersion)
Funders
  • AstraZeneca
  • Bristol-Myers Squibb
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
dapagliflozin, type 1 diabetes, inadequate glycemic control, SGLT2 inhibitors, insulin dose reduction, HbA1c reduction, weight loss, hypoglycemia, adverse events, glycemic variability, drug safety and efficacy
MeSH terms
Adult, Benzhydryl Compounds, Blood Glucose, Body Weight, Diabetes Mellitus, Type 1, Double-Blind Method, Drug Therapy, Combination, Female, Glucosides, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Diabetic Ketoacidosis, Treatment Outcome

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