Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

NCT02460978 | Completed Phase 3 Results DMC

• 3 other identifiers: MB102-2302014-004599-49D1695C00007
• Study Type: interventional
• Target: 815
• Locations: 13 countries
• Sites: 136

Brief Summary

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Conditions

Type 1 Diabetes Mellitus

Keywords

Dapagliflozin; Efficacy; Safety; Add on to insulin; Oral Antidiabetic; Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in HbA1c at Week 24

  To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

  Baseline and 24 weeks

Secondary Outcomes (6)

• Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24

  Baseline and 24 weeks

• Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24

  Baseline and 24 weeks

• Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24

  Baseline and 24 weeks

• Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24

  Baseline and 24 weeks

• Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24

  Baseline and 24 weeks

Study Arms (3)

Dapagliflozin 5 mg

EXPERIMENTAL

Dapagliflozin 5 mg tablet orally, once daily for 52 weeks

Drug: Dapagliflozin

Dapagliflozin 10 mg

EXPERIMENTAL

Dapagliflozin 10 mg tablet orally, once daily for 52 weeks

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo tablet orally, once daily for 52 weeks

Other: Placebo for dapagliflozin

Interventions

Dapagliflozin DRUG

Tablets

Dapagliflozin 10 mg; Dapagliflozin 5 mg

Placebo for dapagliflozin OTHER

Tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Type 1 Diabetes mellitus (T1DM)
• 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

You may not qualify if:

• History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity
• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (136)

Research Site

Concord, California, 94520, United States

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Fresno, California, 93720, United States

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Los Angeles, California, 90057, United States

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Orange, California, 92868, United States

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San Mateo, California, 94401, United States

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San Ramon, California, 94583, United States

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Walnut Creek, California, 94598, United States

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Golden, Colorado, 80401, United States

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Newark, Delaware, 19713, United States

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Bradenton, Florida, 34201, United States

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Clearwater, Florida, 33756, United States

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Fort Lauderdale, Florida, 33312, United States

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Jacksonville, Florida, 32216, United States

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Miami, Florida, 33156, United States

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Miami Springs, Florida, 33166, United States

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St. Petersburg, Florida, 33709, United States

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Tampa, Florida, 33634, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30318, United States

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Roswell, Georgia, 30076, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60611, United States

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Des Moines, Iowa, 50314, United States

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Overland Park, Kansas, 66209, United States

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Lexington, Kentucky, 40502, United States

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Lexington, Kentucky, 40503, United States

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Kalamazoo, Michigan, 49008, United States

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Edina, Minnesota, 55435, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63110, United States

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Reno, Nevada, 89511, United States

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Albuquerque, New Mexico, 87109, United States

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Albany, New York, 12208, United States

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Flushing, New York, 11355, United States

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Mineola, New York, 11501, United States

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New Hyde Park, New York, 11042, United States

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New York, New York, 10029, United States

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Philadelphia, Pennsylvania, 19107-4824, United States

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Amarillo, Texas, 79106, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75231, United States

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Edinburg, Texas, 78539, United States

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Mesquite, Texas, 74194, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78258, United States

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Bennington, Vermont, 05201, United States

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Federal Way, Washington, 98003, United States

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Buenos Aires, 1180AAX, Argentina

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Buenos Aires, C1405BCH, Argentina

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CABA, 1056, Argentina

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Corrientes, 3400, Argentina

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Córdoba, 5000, Argentina

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Córdoba, X5006IKK, Argentina

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Mar del Plata, B7600FZN, Argentina

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Ramos Mejía, B1704ETD, Argentina

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Brussels (Uccle), 1180, Belgium

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Leuven, 3000, Belgium

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Calgary, Alberta, T2V 4J2, Canada

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Edmonton, Alberta, T6G 2E1, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Cambridge, Ontario, N1R 7L6, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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Ottawa, Ontario, K1H 7W9, Canada

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Smiths Falls, Ontario, K7A 4W8, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Santiago, 7500010, Chile

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Santiago, 8053095, Chile

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Temuco, 4781156, Chile

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Dresden, 1307, Germany

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Essen, 45355, Germany

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Falkensee, 14612, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 22607, Germany

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Heidelberg, 69115, Germany

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Oldenburg, 23758, Germany

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Pohlheim, 35415, Germany

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Saarlouis, 66740, Germany

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Sulzbach-Rosenberg, 92237, Germany

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Wangen, 88239, Germany

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Aki-gun, 735-0021, Japan

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Amagasaki-shi, 661-0002, Japan

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Chitose-shi, 066-0032, Japan

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Chūōku, 103-0002, Japan

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Fukuyama-shi, 721-0927, Japan

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Higashiosaka-shi, 577-0802, Japan

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Ibusuki-shi, 891-0401, Japan

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Kagoshima, 892-0824, Japan

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Kamakura-shi, 247-0056, Japan

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Kashiwara-shi, 582-0005, Japan

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Kitakyushu-shi, 807-0857, Japan

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Koriyama-shi, 963-8851, Japan

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Kumamoto, 862-0976, Japan

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Kurume-shi, 830-8543, Japan

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Miura-shi, 238-0101, Japan

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Nagoya, 455-8530, Japan

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Obihiro-shi, 080-0016, Japan

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Osaka, 530-0001, Japan

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Oyama-shi, 323-0022, Japan

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Ōita, 870-0855, Japan

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Sapporo, 060-0001, Japan

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Shibuya-ku, 150-0013, Japan

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Shinjuku-ku, 169-0073, Japan

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Shizuoka, 424-0855, Japan

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Tsukuba, 305-0812, Japan

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Ushiku-shi, 300-1207, Japan

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Uwajima-shi, 798-8510, Japan

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Yokohama, 231-8682, Japan

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Yokohama, 235-0045, Japan

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Hoogeveen, 7909 AA, Netherlands

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Maastricht, 6020 AZ, Netherlands

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Utrecht, 3584 CX, Netherlands

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Bialystok, 15-351, Poland

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Bialystok, 15-435, Poland

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Gdansk, 80-546, Poland

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Krakow, 31-156, Poland

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Krakow, 31-261, Poland

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Krakow, 31-501, Poland

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Lublin, 20-044, Poland

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Warsaw, 04736, Poland

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Wroclaw, 51-685, Poland

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Novosibirsk, 630091, Russia

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Saint Petersburg, 191015, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 199034, Russia

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Gothenburg, 413 45, Sweden

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Helsingborg, 25220, Sweden

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Linköping, 587 58, Sweden

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Uddevalla, 451 80, Sweden

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Olten, 4600, Switzerland

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Sankt Gallen, 9016, Switzerland

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Zollikerberg, 8125, Switzerland

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Manchester, M23 9LT, United Kingdom

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Northampton, NN1 5BD, United Kingdom

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Oldham, OL1 2JH, United Kingdom

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Swansea, SA2 8QA, United Kingdom

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Wakefield, WF1 4DG, United Kingdom

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Related Publications (7)

• 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.

  PMID: 39918875 DERIVED

• 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.

  PMID: 38770818 DERIVED

• 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.

  PMID: 35403243 DERIVED

• 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.

  PMID: 32946821 DERIVED

• 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.

  PMID: 32691513 DERIVED

• 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.

  PMID: 30756462 DERIVED

• 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.

  PMID: 30026335 DERIVED

Related Links

• MB102230\_CSP
• MB102230\_SAP

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Anna Maria Langkilde
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

+46 31 7761000

Study Officials

• Anna Maria Langkilde, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: July 8, 2015
• Primary Completion: September 2, 2017
• Study Completion: April 18, 2018
• Last Updated: March 5, 2019
• Results First Posted: November 6, 2018

Record last verified: 2019-02

Locations

NL (3); GB (5); CL (3); US (47); AR (8); BE (2); PL (9); JP (29); RU (4); CA (8); SE (4); DE (11); CH (3)