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Clinical Trial Details

Trial ID: L3850
Source ID: NCT02268214
Associated Drug: Dapagliflozin
Title: Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Acronym: DEPICT 1
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02268214/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin|DRUG: Placebo for dapagliflozin
Outcome Measures: Primary: 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: Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24, Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model\[RMM\]), From Baseline to Week 24|Adjusted Mean Percent Change in Body Weight From Baseline at Week 24, Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model\[RMM\]), From Baseline to Week 24|Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24, Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model\[RMM\]), From Baseline to Week 24|Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24, Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model\[RMM\]), 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, Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose \> 70 and \<= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model\[RMM\]), From Baseline to Week 24|Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events, Subjects with HbA1c reduction from baseline to week 24 (LOCF) \>= 0.5% and without severe hypoglycemia events, From Baseline to Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 833
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-11-11
Completion Date: 2017-08-25
Results First Posted: 2018-03-29
Last Update Posted: 2018-09-13
Locations: Research Site, Little Rock, Arkansas, 72205, United States|Research Site, Encino, California, 91436, United States|Research Site, La Mesa, California, 91942, United States|Research Site, San Diego, California, 92161, United States|Research Site, Tarzana, California, 91356, United States|Research Site, Torrance, California, 90502, United States|Research Site, Aurora, Colorado, 80045, United States|Research Site, Denver, Colorado, 80220, United States|Research Site, Cooper City, Florida, 33024, United States|Research Site, Jacksonville, Florida, 32258, United States|Research Site, Miami, Florida, 33136, United States|Research Site, Port Orange, Florida, 32127, United States|Research Site, Idaho Falls, Idaho, 83404-7596, United States|Research Site, Des Moines, Iowa, 50314, United States|Research Site, Louisville, Kentucky, 40213, United States|Research Site, Portland, Maine, 04101, United States|Research Site, Hyattsville, Maryland, 20782, United States|Research Site, Rockville, Maryland, 20852, United States|Research Site, Kalamazoo, Michigan, 49008, United States|Research Site, Minneapolis, Minnesota, 55416, United States|Research Site, Chesterfield, Missouri, 63017, United States|Research Site, Las Vegas, Nevada, 89148, United States|Research Site, Albany, New York, 12206, United States|Research Site, Buffalo, New York, 14215, United States|Research Site, Asheville, North Carolina, 28803, United States|Research Site, Chapel Hill, North Carolina, 27517, United States|Research Site, Greenville, North Carolina, 27834, United States|Research Site, Morehead City, North Carolina, 28557, United States|Research Site, Langhorne, Pennsylvania, 19047, United States|Research Site, Kingsport, Tennessee, 37660, United States|Research Site, Nashville, Tennessee, 37212, United States|Research Site, Amarillo, Texas, 79106, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, Houston, Texas, 77090, United States|Research Site, Salt Lake City, Utah, 84108, United States|Research Site, Olympia, Washington, 98502, United States|Research Site, Concord, 2139, Australia|Research Site, Daw Park, 5041, Australia|Research Site, Fitzroy, 3065, Australia|Research Site, Heidelberg West, 3081, Australia|Research Site, Newcastle, 2291, Australia|Research Site, Southport, 4215, Australia|Research Site, Wollongong, 2500, Australia|Research Site, Innsbruck, 6020, Austria|Research Site, Saint Stefan/Stainz, 8511, Austria|Research Site, Wien, 1060, Austria|Research Site, Wien, 1090, Austria|Research Site, Wien, 1130, Austria|Research Site, Bonheiden, 2820, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Liege, B-4000, Belgium|Research Site, Vancouver, British Columbia, V5Y 3W2, Canada|Research Site, Winnipeg, Manitoba, R3E 3P4, Canada|Research Site, London, Ontario, N6A 4V2, Canada|Research Site, Laval, Quebec, H7T 2P5, Canada|Research Site, Arhus C, 8000, Denmark|Research Site, Esbjerg, 6700, Denmark|Research Site, Odense, 5000, Denmark|Research Site, Randers NØ, 8930, Denmark|Research Site, Helsinki, 00014, Finland|Research Site, Jyvaskyla, 40100, Finland|Research Site, Kuopio, 70100, Finland|Research Site, Oulu, 90100, Finland|Research Site, Tampere, 33520, Finland|Research Site, Besançon Cedex, 25000, France|Research Site, Corbeil-Essonnes, 91106, France|Research Site, Dijon, 21000, France|Research Site, SAINT HERBLAIN Cedex, 44805, France|Research Site, Vandoeuvre les Nancy, 54500, France|Research Site, Aschaffenburg, 63739, Germany|Research Site, Aßlar, 35614, Germany|Research Site, Bad Oeynhausen, 32545, Germany|Research Site, Falkensee, 14612, Germany|Research Site, Munich, 80939, Germany|Research Site, Munster, 48145, Germany|Research Site, Neuwied, 56564, Germany|Research Site, Oldenburg, 23758, Germany|Research Site, Pohlheim, 35415, Germany|Research Site, Schweinfurt, 97421, Germany|Research Site, Sulzbach, 92237, Germany|Research Site, Witten, 58455, Germany|Research Site, Baja, 6500, Hungary|Research Site, Balatonfured, 8230, Hungary|Research Site, Budapest, 1213, Hungary|Research Site, Létavértes, 4281, Hungary|Research Site, Szeged, 6726, Hungary|Research Site, Zalaegerszeg, 8900, Hungary|Research Site, Haifa, 31096, Israel|Research Site, Jerusalem, 91120, Israel|Research Site, Safed, 13100, Israel|Research Site, Tel-Aviv, 61480, Israel|Research Site, Tikva, 49202, Israel|Research Site, Firenze, 50141, Italy|Research Site, Milano, 20132, Italy|Research Site, Padowa, 35100, Italy|Research Site, Palermo, 90127, Italy|Research Site, Ravenna, 48100, Italy|Research Site, Sesto San Giovanni, 20099, Italy|Research Site, Siena, 53100, Italy|Research Site, Aguascalientes, 20230, Mexico|Research Site, Chihuahua, 31237, Mexico|Research Site, Cuernavaca, 62250, Mexico|Research Site, Guadalajara, 44150, Mexico|Research Site, Merida, 97070, Mexico|Research Site, Mexico, 6090, Mexico|Research Site, Monterrey, 64020, Mexico|Research Site, Monterrey, 64460, Mexico|Research Site, Torreon, 27000, Mexico|Research Site, Zapopan, Jalisco, 45200, Mexico|Research Site, Zapopan, 45116, Mexico|Research Site, Bucuresti, 010825, Romania|Research Site, Bucuresti, 020045, Romania|Research Site, Dolj, 200134, Romania|Research Site, Galati, 800098, Romania|Research Site, Iasi, 700515, Romania|Research Site, Timisoara, 300736, Romania|Research Site, A Coruña, 15006, Spain|Research Site, Almeria, 04001, Spain|Research Site, Barcelona, 08036, Spain|Research Site, Sevilla, 41071, Spain|Research Site, Valencia, 46009, Spain|Research Site, Göteborg, 413 45, Sweden|Research Site, Karlstad, 651 85, Sweden|Research Site, Lund, 22185, Sweden|Research Site, Uppsala, 75185, Sweden|Research Site, Belfast, BT12 6BA, United Kingdom|Research Site, Chesterfield, S40 4AA, United Kingdom|Research Site, Dundee, DD1 9SY, United Kingdom|Research Site, Nottingham, NG7 2UH, United Kingdom|Research Site, Sheffield, S5 7AU, United Kingdom|Research Site, Welwyn Garden City, AL7 4HQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02268214

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details