Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes: the DEPICT-1 52-week study
Abstract
OBJECTIVE This study evaluated the long-term safety and efficacy of dapagliflozin as an adjunct to adjustable insulin in patients with type 1 diabetes and inadequate glycemic control. RESEARCH DESIGN AND METHODS DEPICT-1 (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes) was a randomized (1:1:1), double-blind, placebo-controlled phase 3 study of dapagliflozin 5 mg and 10 mg in patients with type 1 diabetes (HbA1c 7.5–10.5% [58–91 mmol/mol]) (NCT02268214). The results of the 52-week study, consisting of the 24-week short-term and 28-week extension period, are reported here. RESULTS Of the 833 patients randomized into the study, 708 (85%) completed the 52-week study. Over 52 weeks, dapagliflozin 5 mg and 10 mg led to clinically significant reductions in HbA1c (difference vs. placebo [95% CI] −0.33% [−0.49, −0.17] [−3.6 mmol/mol (−5.4, −1.9)] and −0.36% [−0.53, −0.20] [−3.9 mmol/mol (−5.8, −2.2)], respectively) and body weight (difference vs. placebo [95% CI] −2.95% [−3.83, −2.06] and −4.54% [−5.40, −3.66], respectively). Serious adverse events were reported in 13.4%, 13.5%, and 11.5% of patients in the dapagliflozin 5 mg, 10 mg, and placebo groups, respectively. Although hypoglycemia events were comparable across treatment groups, more patients in the dapagliflozin groups had events adjudicated as definite diabetic ketoacidosis (DKA; 4.0%, 3.4%, and 1.9% in dapagliflozin 5 mg, 10 mg, and placebo groups, respectively). CONCLUSIONS Over 52 weeks, dapagliflozin led to improvements in glycemic control and weight loss in patients with type 1 diabetes, while increasing the risk of DKA.
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Each incremental 5% increase in TIR is associated with clinically significant benefits for people with type 1 or type 2 diabetes.
“Importantly, as demonstrated by Beck et al. (25), Vigersky et al. (26) and Feig et al. (47), even small, incremental improvements yield significant glycemic benefits.”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [47]
Each incremental 5% increase in TIR is associated with clinically significant benefits for Pregnancy Type 1.
“Each incremental 5% increase in TIR is associated with clinically significant benefits for Pregnancy Type 1 (47; 48)”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [47]
Data from Sweden and the CONCEPTT control group report 50% TIR in the first trimester, improving to 60% TIR in the third trimester.
“Data from Sweden, and the CONCEPTT control group, report 50% TIR in the first trimester, improving to 60% TIR in the third trimester, reflecting contemporary antenatal care.”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [47]
A 5% increase in TIR is clinically significant in improving glycemic control.
“emphasizing that what may appear to be small, incremental successes (e.g. 5% increase in TIR) are, in fact, clinically significant in improving their glycemic control (25; 26; 47).”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [47]
Even small, incremental improvements yield significant glycemic benefits.
“Importantly, as demonstrated by Beck et al. (25), Vigersky et al. (26) and Feig et al. (47), even small, incremental improvements yield significant glycemic benefits.”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [47]
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References 36 · Cited by 243
- Authors
- Dandona, P., Mathieu, C., Phillip, M., Hansen, L., Tschöpe, D., Thorén, F., Xu, J., Langkilde, A. M., DEPICT-1 Investigators, Proietto, J., Stranks, S., Chen, R., O'Neal, D., Pape, A., Forbes, M., Morbey, C., Luger, A., Hanusch, U., Schnack, C., Fliesser-Goerzer, E., Hoelzl, B., Ebenbichler, C., Prager, R., Van Gaal, L., Vercammen, C., Scheen, A., Mathieu, C., Duyck, F., Nobels, F., Ruige, J., Aggarwal, N., Woo, V., St-Pierre, B., Dumas, R., Hramiak, I., Elliott, T., Hansen, T. K., Henriksen, J. E., Gram, J., Lihn, A., Bruun, J., Saltevo, J., Taurio, J., Strand, J., Valle, T., Nieminen, S., Pietilainen, K., Guerci, B., Hadjadj, S., Cariou, B., Verges, B., Borot, S., Penfornis, A., Tschöpe, D., Schaum, T., Marck, C., Horacek, T., Rose, L., Klausmann, G., Luedemann, J., Appelt, S., Aigner, U., Goebel, R., Behnke, T., Ziegler, A.-G., Peterfai, E., Kerenyi, Z., Oroszlan, T., Kiss, G. G., Konyves, L., Piros, G., Phillip, M., Mosenzon, O., Shehadeh, N., Adawi, F., Wainstein, J., Dotta, F., Piatti, P., Genovese, S., Consoli, A., Di Bartolo, P., Mannucci, E., Giordano, C., Lapolla, A., Aguilar, C., Bazzoni Ruiz, A. E., Mondragon Ramirez, G., Orozco, E. P., Stobschinski de Alba, C. A., Medina Pech, C. E., Garza Ruiz, J., Sauque Reyna, L., Llamas Esperon, G., Nevarez Ruiz, L. A., Velazquez, M. V., Flores Lozano, F., Gonzalez Gonzalez, J. G., Garcia-Hernandez, P. A., Araujo Silva, R., Villeda-Espinosa, E., Mistodie, C., Popescu, D., Constantin, C., Nicolau, A., Popa, B., Timar, R., Serafinceanu, C., Pintilei, E., Soto, A., Gimenez, M., Merino, J., Morales, C., Mezquita, P., Jendle, J., Tengmark, B.-O., Eriksson, J., Londahl, M., Eliasson, B., Gunstone, A., Heller, S. R., Darzy, K., Mansell, P., Davies, M., Reed, R., Browne, D., Courtney, H., Turner, W., Blagden, M., McCrimmon, R., Dandona, P., Bergenstal, R., Lane, W., Lucas, K., White, A., Bao, S., White, J., Jantzi, C., Rasouli, N., Ervin, W., Lewy-Alterbaum, L., Handelsman, Y., Miranda-Palma, B., Cleland, A., Fink, R., Rodbard, H., Nakhle, S., Greenberg, C., Schorr, A., Bays, H., Simmons, D., Klein, E., Kane, L., Fishman, N., Ipp, E., Garg, S., Bhargava, A., Singh, M. Z., Rosenstock, J., Thrasher, J., Warren, M., Young, L., Aroda, V., Pettus, J., Liljenquist, D., Busch, R., Wise, J., Kayne, D., & Biggs, W.
- Affiliations
- Bristol-Myers Squibb (United States) (US)
- AstraZeneca, Gothenburg, Sweden
- AstraZeneca (United States) (US)
- AstraZeneca (Sweden) (SE)
- ORCID
- Hansen, Lars
- Xu, John
- Langkilde, Anna Maria
- Chen, Roger
- O'Neal, David
- Ebenbichler, Christoph
- Vercammen, Chris
- Nobels, Frank
- Aggarwal, Naresh
- Woo, Vincent
- Hramiak, Irene
- Elliott, Thomas
- Hansen, Troels Krarup
- Henriksen, Jan Erik
- Bruun, Jens
- Taurio, Jyrki
- Guerci, Bruno
- Hadjadj, Samy
- Cariou, Bertrand
- Borot, Sophie
- Penfornis, Alfred
- Ziegler, Anette-Gabriele
- Mosenzon, Ofri
- Shehadeh, Naim
- Wainstein, Julio
- Dotta, Francesco
- Genovese, Stefano
- Consoli, Agostino
- Mannucci, Edoardo
- Giordano, Carla
- Lapolla, Annunziata
- Constantin, Ciprian
- Timar, Romulus
- Soto, Alfonso
- Jendle, Johan
- Eriksson, Jan
- Heller, Simon R.
- Davies, Melanie
- McCrimmon, Rory
- Bergenstal, Richard
- Lane, Wendy
- Lucas, Kathryn
- Bao, Shichun
- Rasouli, Neda
- Handelsman, Yehuda
- Rodbard, Helena
- Bays, Harold
- Ipp, Eli
- Garg, Satish
- Bhargava, Anuj
- Rosenstock, Julio
- Warren, Mark
- Young, Laura
- Aroda, Vanita
- Pettus, Jeremy
- Busch, Robert
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2018-10-23
- Volume
- 41
- Issue
- 12
- Pages
- 2552-2559
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2896925990
- Cited by
- 243
- References
- 36
- Citations by year
- 2026: 20 · 2025: 30 · 2024: 15 · 2023: 33 · 2022: 21 · 2021: 35 · 2020: 46 · 2019: 38 · 2018: 4 · 2016: 1
- FWCI
- 24.45
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Lirias (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, HbA1c reduction, weight loss, diabetic ketoacidosis, hypoglycemia, insulin therapy, long-term safety
- MeSH terms
- Adult, Benzhydryl Compounds, Blood Glucose, Diabetes Mellitus, Type 1, Double-Blind Method, Drug Therapy, Combination, Female, Glucosides, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Placebos, Weight Loss, Treatment Outcome
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