The DOI matches its Crossref record; 23 of the 23 references it cites were found in a registry or an index.
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
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 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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“Even when target HbA1c levels are achieved, there is still evidence for excess mortality in patients with type 1 diabetes (3).”
BackgroundSelf-citationRisk of hypoglycaemia in types 1 and 2 diabetes: Effects of treatment modalities and their duration
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10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2024
American Diabetes Association Professional Practice Committee, ElSayed, N. A., Aleppo, G., Bannuru, R. R., Bruemmer, D., Collins, B. S., Das, S. R., Ekhlaspour, L., Hilliard, M. E., Johnson, E. L., et al. (2024) · Diabetes Care · doi:10.2337/dc24-s010 · Cited by 438
Danne, T., Garg, S., Peters, A. L., Buse, J. B., Mathieu, C., Pettus, J. H., Alexander, C. M., Battelino, T., Ampudia-Blasco, F. J., Bode, B. W., et al. (2019) · Diabetes Care · doi:10.2337/dc18-2316 · Cited by 379
Self-citation10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Das, S. R., Echouffo-Tcheugui, J. B., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s010 · Cited by 339
Self-citationBuzzetti, R., Tuomi, T., Mauricio, D., Pietropaolo, M., Zhou, Z., Pozzilli, P., & Leslie, R. D. (2020) · Diabetes · doi:10.2337/dbi20-0017 · Cited by 305
Carbohydrate-based drugs launched during 2000−2021
Cao, X., Du, X., Jiao, H., An, Q., Chen, R., Fang, P., Wang, J., & Yu, B. (2022) · Acta Pharmaceutica Sinica B · doi:10.1016/j.apsb.2022.05.020 · Cited by 285
Metadata
- 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
- Mathieu, Chantal
- Dandona, Paresh
- Araki, Eiichi
- Hansen, Lars
- Langkilde, Anna Maria
- Pedersen, Sue
- Punthakee, Zubin
- Lochnan, Heather
- Woo, Vincent
- Elliott, Thomas
- Reichel, Andreas
- Seufert, Jochen
- Birkenfeld, Andreas L.
- Onishi, Yukiko
- Seino, Hiroaki
- Sato, Yuichi
- Nunoi, Kiyohide
- Ikeda, Hiroki
- Yokoyama, Hiroki
- Miyauchi, Shozo
- Hasegawa, Atsushi
- Jinnouchi, Hideaki
- Watanabe, Takayuki
- Ohashi, Hiroshi
- Maeda, Hajime
- De Valk, H.W.
- Kooy, Adriaan
- Madziarska, Katarzyna
- Rudofsky, Gottfried
- Malecki, Maciej
- Karpova, Irina
- Zalevskaya, Alsu
- Sardinov, Ruslan
- Schultes, Bernd
- Issa, Basil G.
- Hsia, Stanley
- Jenders, Robert
- Aleppo, Grazia
- Sugimoto, Danny
- Twahirwa, Marcel
- Klonoff, David
- McGill, Janet
- Bredefeld, Cindy
- Donovan, Daniel
- Ipp, Eli
- Bhargava, Anuj
- Bao, Shichun
- 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
- 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
- FWCI
- 29.05
- Type
- journal article
- Language
- en
- Open access
- closed
- 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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