Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
NCT ID: NCT02460978
Last Updated: 2019-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
815 participants
INTERVENTIONAL
2015-07-08
2018-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dapagliflozin 5 mg
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
Dapagliflozin
Tablets
Dapagliflozin 10 mg
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
Dapagliflozin
Tablets
Placebo
Placebo tablet orally, once daily for 52 weeks
Placebo for dapagliflozin
Tablets
Interventions
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Dapagliflozin
Tablets
Placebo for dapagliflozin
Tablets
Eligibility Criteria
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Inclusion Criteria
* Central laboratory C-peptide \< 0.7 ng/ml (0.23 nmol/L)
* Insulin use for at least 12 months per patient reported or medical records
* Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening
* Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to screening
* If on MDI insulin administration, subject must be on ≥ 3x injections per day
* Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%
* Body mass index (BMI) ≥ 18.5 kg/m2
Exclusion Criteria
* Taking any non-insulin antihyperglicemic agent within 1 month prior to screening
* Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration
* Taking metformin and/or thiazolidinediones within 2 months prior to screening
* History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening
* History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening
* Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening
* History of Addison's disease
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Maria Langkilde, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Concord, California, United States
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Fresno, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Mateo, California, United States
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San Ramon, California, United States
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Walnut Creek, California, United States
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Golden, Colorado, United States
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Newark, Delaware, United States
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Bradenton, Florida, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami Springs, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Roswell, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Des Moines, Iowa, United States
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Overland Park, Kansas, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Kalamazoo, Michigan, United States
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Edina, Minnesota, United States
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Jefferson City, Missouri, United States
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St Louis, Missouri, United States
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Reno, Nevada, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Flushing, New York, United States
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Mineola, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Philadelphia, Pennsylvania, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Edinburg, Texas, United States
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Mesquite, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Bennington, Vermont, United States
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Federal Way, Washington, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Corrientes, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Ramos Mejía, , Argentina
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Brussels (Uccle), , Belgium
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Leuven, , Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Cambridge, Ontario, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Smiths Falls, Ontario, Canada
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Sherbrooke, Quebec, Canada
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Dresden, , Germany
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Essen, , Germany
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Falkensee, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Oldenburg, , Germany
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Pohlheim, , Germany
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Saarlouis, , Germany
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Sulzbach-Rosenberg, , Germany
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Wangen, , Germany
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Aki-gun, , Japan
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Amagasaki-shi, , Japan
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Chitose-shi, , Japan
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Chūōku, , Japan
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Fukuyama-shi, , Japan
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Higashiosaka-shi, , Japan
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Ibusuki-shi, , Japan
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Kagoshima, , Japan
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Kamakura-shi, , Japan
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Kashiwara-shi, , Japan
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Kitakyushu-shi, , Japan
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Koriyama-shi, , Japan
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Kumamoto, , Japan
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Kurume-shi, , Japan
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Miura-shi, , Japan
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Nagoya, , Japan
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Obihiro-shi, , Japan
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Osaka, , Japan
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Oyama-shi, , Japan
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Ōita, , Japan
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Sapporo, , Japan
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Shibuya-ku, , Japan
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Shinjuku-ku, , Japan
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Shizuoka, , Japan
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Tsukuba, , Japan
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Ushiku-shi, , Japan
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Uwajima-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Hoogeveen, , Netherlands
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Maastricht, , Netherlands
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Utrecht, , Netherlands
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Bialystok, , Poland
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Bialystok, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Gothenburg, , Sweden
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Helsingborg, , Sweden
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Linköping, , Sweden
Research Site
Uddevalla, , Sweden
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Olten, , Switzerland
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Sankt Gallen, , Switzerland
Research Site
Zollikerberg, , Switzerland
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Manchester, , United Kingdom
Research Site
Northampton, , United Kingdom
Research Site
Oldham, , United Kingdom
Research Site
Swansea, , United Kingdom
Research Site
Wakefield, , United Kingdom
Countries
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References
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Nardone M, Kugathasan L, Sridhar VS, Dutta P, Campbell DJT, Layton AT, Perkins BA, Barbour S, Lam TKT, Levin A, Lovblom LE, Mucsi I, Rabasa-Lhoret R, Rac VE, Senior P, Sigal RJ, Stanimirovic A, Persson F, Stougaard EB, Doria A, Cherney DZI. Modeling Cardiorenal Protection with Sodium-Glucose Cotransporter 2 Inhibition in Type 1 Diabetes: An Analysis of DEPICT-1 and DEPICT-2. Clin J Am Soc Nephrol. 2025 Apr 1;20(4):529-538. doi: 10.2215/CJN.0000000641. Epub 2025 Feb 7.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Melin J, Tang W, Rekic D, Hamren B, Penland RC, Boulton DW, Parkinson J. Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus. J Clin Pharmacol. 2022 Oct;62(10):1227-1235. doi: 10.1002/jcph.2062. Epub 2022 May 2.
Groop PH, Dandona P, Phillip M, Gillard P, Edelman S, Jendle J, Xu J, Scheerer MF, Thoren F, Iqbal N, Repetto E, Mathieu C. Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials. Lancet Diabetes Endocrinol. 2020 Oct;8(10):845-854. doi: 10.1016/S2213-8587(20)30280-1.
Mathieu C, Dandona P, Birkenfeld AL, Hansen TK, Iqbal N, Xu J, Repetto E, Scheerer MF, Thoren F, Phillip M. Benefit/risk profile of dapagliflozin 5 mg in the DEPICT-1 and -2 trials in individuals with type 1 diabetes and body mass index >/=27 kg/m2. Diabetes Obes Metab. 2020 Nov;22(11):2151-2160. doi: 10.1111/dom.14144. Epub 2020 Aug 20.
Parkinson J, Tang W, Astrand M, Melin J, Ekholm E, Hamren B, Boulton DW. Model-based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2019 Jun;21(6):1381-1387. doi: 10.1111/dom.13664. Epub 2019 Mar 14.
Mathieu C, Dandona P, Gillard P, Senior P, Hasslacher C, Araki E, Lind M, Bain SC, Jabbour S, Arya N, Hansen L, Thoren F, Langkilde AM; DEPICT-2 Investigators. 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. Diabetes Care. 2018 Sep;41(9):1938-1946. doi: 10.2337/dc18-0623. Epub 2018 Jul 19.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Other Identifiers
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2014-004599-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1695C00007
Identifier Type: OTHER
Identifier Source: secondary_id
MB102-230
Identifier Type: -
Identifier Source: org_study_id
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