Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
DEPICT 1
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus
3 other identifiers
interventional
833
16 countries
126
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2014
Typical duration for phase_3
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedStudy Start
First participant enrolled
November 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2017
CompletedResults Posted
Study results publicly available
March 29, 2018
CompletedSeptember 13, 2018
August 1, 2018
2.2 years
October 15, 2014
March 2, 2018
August 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change in HbA1c From Baseline at Week 24
Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model\[RMM\]).
From Baseline to Week 24
Secondary Outcomes (6)
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
From Baseline to Week 24
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
From Baseline to Week 24
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
From Baseline to Week 24
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24
From Baseline to Week 24
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24
From Baseline to Week 24
- +1 more secondary outcomes
Study Arms (3)
Arm A: Dapagliflozin
EXPERIMENTALDapagliflozin 5 mg tablet orally, once daily for 52 weeks
Arm B: Dapagliflozin
EXPERIMENTALDapagliflozin 10 mg tablet orally, once daily for 52 weeks
Arm C: Placebo for Dapagliflozin
PLACEBO COMPARATORPlacebo tablet orally, once daily for 52 weeks
Interventions
Eligibility Criteria
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (131)
Research Site
Little Rock, Arkansas, 72205, United States
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Encino, California, 91436, United States
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La Mesa, California, 91942, United States
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San Diego, California, 92161, United States
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Tarzana, California, 91356, United States
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Torrance, California, 90502, United States
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Aurora, Colorado, 80045, United States
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Denver, Colorado, 80220, United States
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Cooper City, Florida, 33024, United States
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Jacksonville, Florida, 32258, United States
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Miami, Florida, 33136, United States
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Port Orange, Florida, 32127, United States
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Idaho Falls, Idaho, 83404-7596, United States
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Des Moines, Iowa, 50314, United States
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Louisville, Kentucky, 40213, United States
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Portland, Maine, 04101, United States
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Hyattsville, Maryland, 20782, United States
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Rockville, Maryland, 20852, United States
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Kalamazoo, Michigan, 49008, United States
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Minneapolis, Minnesota, 55416, United States
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Chesterfield, Missouri, 63017, United States
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Las Vegas, Nevada, 89148, United States
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Albany, New York, 12206, United States
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Buffalo, New York, 14215, United States
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Asheville, North Carolina, 28803, United States
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Chapel Hill, North Carolina, 27517, United States
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Greenville, North Carolina, 27834, United States
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Morehead City, North Carolina, 28557, United States
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Langhorne, Pennsylvania, 19047, United States
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Kingsport, Tennessee, 37660, United States
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Nashville, Tennessee, 37212, United States
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Amarillo, Texas, 79106, United States
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Dallas, Texas, 75230, United States
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Houston, Texas, 77090, United States
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Salt Lake City, Utah, 84108, United States
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Olympia, Washington, 98502, United States
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Concord, 2139, Australia
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Daw Park, 5041, Australia
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Fitzroy, 3065, Australia
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Heidelberg West, 3081, Australia
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Newcastle, 2291, Australia
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Southport, 4215, Australia
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Wollongong, 2500, Australia
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Innsbruck, 6020, Austria
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Saint Stefan/Stainz, 8511, Austria
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Vienna, 1060, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Bonheiden, 2820, Belgium
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Leuven, 3000, Belgium
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Liège, B-4000, Belgium
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Vancouver, British Columbia, V5Y 3W2, Canada
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Winnipeg, Manitoba, R3E 3P4, Canada
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London, Ontario, N6A 4V2, Canada
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Laval, Quebec, H7T 2P5, Canada
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Arhus C, 8000, Denmark
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Esbjerg, 6700, Denmark
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Odense, 5000, Denmark
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Randers NØ, 8930, Denmark
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Helsinki, 00014, Finland
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Jyväskylä, 40100, Finland
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Kuopio, 70100, Finland
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Oulu, 90100, Finland
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Tampere, 33520, Finland
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Besançon, 25000, France
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Corbeil-Essonnes, 91106, France
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Dijon, 21000, France
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Saint-Herblain, 44805, France
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Vandœuvre-lès-Nancy, 54500, France
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Aschaffenburg, 63739, Germany
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Aßlar, 35614, Germany
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Bad Oeynhausen, 32545, Germany
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Falkensee, 14612, Germany
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Munich, 80939, Germany
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Münster, 48145, Germany
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Neuwied, 56564, Germany
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Oldenburg, 23758, Germany
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Pohlheim, 35415, Germany
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Schweinfurt, 97421, Germany
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Sulzbach, 92237, Germany
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Witten, 58455, Germany
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Baja, 6500, Hungary
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Balatonfüred, 8230, Hungary
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Budapest, 1213, Hungary
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Létavértes, 4281, Hungary
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Szeged, 6726, Hungary
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Zalaegerszeg, 8900, Hungary
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Safed, 13100, Israel
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Tel Aviv, 61480, Israel
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Tikva, 49202, Israel
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Florence, 50141, Italy
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Milan, 20132, Italy
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Padowa, 35100, Italy
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Palermo, 90127, Italy
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Ravenna, 48100, Italy
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Sesto San Giovanni, 20099, Italy
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Siena, 53100, Italy
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Aguascalientes, 20230, Mexico
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Chihuahua City, 31237, Mexico
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Cuernavaca, 62250, Mexico
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Guadalajara, 44150, Mexico
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Mérida, 97070, Mexico
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México, 6090, Mexico
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Monterrey, 64020, Mexico
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Monterrey, 64460, Mexico
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Torreón, 27000, Mexico
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Zapopan, 45116, Mexico
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Zapopan, Jalisco, 45200, Mexico
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Bucharest, 010825, Romania
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Bucharest, 020045, Romania
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Dolj, 200134, Romania
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Galati, 800098, Romania
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Iași, 700515, Romania
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Timișoara, 300736, Romania
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A Coruña, 15006, Spain
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Almería, 04001, Spain
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Barcelona, 08036, Spain
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Seville, 41071, Spain
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Valencia, 46009, Spain
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Gothenburg, 413 45, Sweden
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Karlstad, 651 85, Sweden
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Lund, 22185, Sweden
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Uppsala, 75185, Sweden
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Belfast, BT12 6BA, United Kingdom
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Chesterfield, S40 4AA, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
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Sheffield, S5 7AU, United Kingdom
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Welwyn Garden City, AL7 4HQ, United Kingdom
Related Publications (8)
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: 39918875DERIVEDNatale 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: 38770818DERIVEDMelin 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: 35403243DERIVEDGroop 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: 32946821DERIVEDMathieu 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: 32691513DERIVEDParkinson 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: 30756462DERIVEDDandona 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.
PMID: 30352894DERIVEDDandona 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.
PMID: 28919061DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anna Maria Langkilde
- Organization
- AstraZenenca
Study Officials
- STUDY DIRECTOR
Anna Maria Langkilde
AstraZeneca
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
October 15, 2014
First Posted
October 20, 2014
Study Start
November 11, 2014
Primary Completion
January 4, 2017
Study Completion
August 25, 2017
Last Updated
September 13, 2018
Results First Posted
March 29, 2018
Record last verified: 2018-08