Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
NCT ID: NCT02268214
Last Updated: 2018-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
833 participants
INTERVENTIONAL
2014-11-11
2017-08-25
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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Arm A: Dapagliflozin
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
Dapagliflozin
Tablets
Arm B: Dapagliflozin
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
Dapagliflozin
Tablets
Arm C: Placebo for Dapagliflozin
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 metformin and/or thiazolidinediones within 2 months prior to screening
* Taking any antidiabetic medication (other than insulin), 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
* 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
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Little Rock, Arkansas, United States
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Encino, California, United States
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La Mesa, California, United States
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San Diego, California, United States
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Tarzana, California, United States
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Torrance, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Cooper City, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Port Orange, Florida, United States
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Idaho Falls, Idaho, United States
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Des Moines, Iowa, United States
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Louisville, Kentucky, United States
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Portland, Maine, United States
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Hyattsville, Maryland, United States
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Rockville, Maryland, United States
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Kalamazoo, Michigan, United States
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Minneapolis, Minnesota, United States
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Chesterfield, Missouri, United States
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Las Vegas, Nevada, United States
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Albany, New York, United States
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Buffalo, New York, United States
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Asheville, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Greenville, North Carolina, United States
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Morehead City, North Carolina, United States
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Langhorne, Pennsylvania, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Olympia, Washington, United States
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Concord, , Australia
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Daw Park, , Australia
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Fitzroy, , Australia
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Heidelberg West, , Australia
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Newcastle, , Australia
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Southport, , Australia
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Wollongong, , Australia
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Innsbruck, , Austria
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Saint Stefan/Stainz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Bonheiden, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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London, Ontario, Canada
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Laval, Quebec, Canada
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Arhus C, , Denmark
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Esbjerg, , Denmark
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Odense, , Denmark
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Randers NØ, , Denmark
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Helsinki, , Finland
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Jyväskylä, , Finland
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Kuopio, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Besançon, , France
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Corbeil-Essonnes, , France
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Dijon, , France
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Saint-Herblain, , France
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Vandœuvre-lès-Nancy, , France
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Aschaffenburg, , Germany
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Aßlar, , Germany
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Bad Oeynhausen, , Germany
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Falkensee, , Germany
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Munich, , Germany
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Münster, , Germany
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Neuwied, , Germany
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Oldenburg, , Germany
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Pohlheim, , Germany
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Schweinfurt, , Germany
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Sulzbach, , Germany
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Witten, , Germany
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Baja, , Hungary
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Létavértes, , Hungary
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Szeged, , Hungary
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Zalaegerszeg, , Hungary
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Haifa, , Israel
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Jerusalem, , Israel
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Safed, , Israel
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Tel Aviv, , Israel
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Tikva, , Israel
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Florence, , Italy
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Milan, , Italy
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Padowa, , Italy
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Palermo, , Italy
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Ravenna, , Italy
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Sesto San Giovanni, , Italy
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Siena, , Italy
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Aguascalientes, , Mexico
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Chihuahua City, , Mexico
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Cuernavaca, , Mexico
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Guadalajara, , Mexico
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Mérida, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Torreón, , Mexico
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Zapopan, , Mexico
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Zapopan, Jalisco, , Mexico
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Bucharest, , Romania
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Bucharest, , Romania
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Dolj, , Romania
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Galati, , Romania
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Iași, , Romania
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Timișoara, , Romania
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A Coruña, , Spain
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Almería, , Spain
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Barcelona, , Spain
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Seville, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Karlstad, , Sweden
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Lund, , Sweden
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Uppsala, , Sweden
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Belfast, , United Kingdom
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Chesterfield, , United Kingdom
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Dundee, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
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Welwyn Garden City, , 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.
Dandona P, Mathieu C, Phillip M, Hansen L, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study. Diabetes Care. 2018 Dec;41(12):2552-2559. doi: 10.2337/dc18-1087. Epub 2018 Oct 23.
Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):864-876. doi: 10.1016/S2213-8587(17)30308-X. Epub 2017 Sep 14.
Related Links
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Other Identifiers
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2013-004674-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1695C00006
Identifier Type: OTHER
Identifier Source: secondary_id
MB102-229
Identifier Type: -
Identifier Source: org_study_id
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