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Clinical Trial Details

Trial ID: L6522
Source ID: NCT02460978
Associated Drug: Dapagliflozin
Title: Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Acronym: DEPICT 2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02460978/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin|OTHER: Placebo for dapagliflozin
Outcome Measures: Primary: 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: Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24, To compare the percent change from baseline in total daily insulin dose with 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|Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24, To compare the percentage change from baseline in body weight with 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|Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24, To compare the change from baseline in mean value of 24-hour glucose readings obtained from CGM with 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|Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24, To compare the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour glucose readings obtained from CGM with 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|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, To compare the 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 with 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|Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24, To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the proportion of subjects achieving an HbA1c reduction from baseline to Week 24 visit \>=0.5% without severe hypoglycemia events, Baseline and 24 weeks
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 815
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-07-08
Completion Date: 2018-04-18
Results First Posted: 2018-11-06
Last Update Posted: 2019-03-05
Locations: Research Site, Concord, California, 94520, United States|Research Site, Fresno, California, 93720, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Orange, California, 92868, United States|Research Site, San Mateo, California, 94401, United States|Research Site, San Ramon, California, 94583, United States|Research Site, Walnut Creek, California, 94598, United States|Research Site, Golden, Colorado, 80401, United States|Research Site, Newark, Delaware, 19713, United States|Research Site, Bradenton, Florida, 34201, United States|Research Site, Clearwater, Florida, 33756, United States|Research Site, Fort Lauderdale, Florida, 33312, United States|Research Site, Jacksonville, Florida, 32216, United States|Research Site, Miami Springs, Florida, 33166, United States|Research Site, Miami, Florida, 33156, United States|Research Site, Saint Petersburg, Florida, 33709, United States|Research Site, Tampa, Florida, 33634, United States|Research Site, Atlanta, Georgia, 30308, United States|Research Site, Atlanta, Georgia, 30318, United States|Research Site, Roswell, Georgia, 30076, United States|Research Site, Chicago, Illinois, 60607, United States|Research Site, Chicago, Illinois, 60611, United States|Research Site, Des Moines, Iowa, 50314, United States|Research Site, Overland Park, Kansas, 66209, United States|Research Site, Lexington, Kentucky, 40502, United States|Research Site, Lexington, Kentucky, 40503, United States|Research Site, Kalamazoo, Michigan, 49008, United States|Research Site, Edina, Minnesota, 55435, United States|Research Site, Jefferson City, Missouri, 65109, United States|Research Site, Saint Louis, Missouri, 63110, United States|Research Site, Reno, Nevada, 89511, United States|Research Site, Albuquerque, New Mexico, 87109, United States|Research Site, Albany, New York, 12208, United States|Research Site, Flushing, New York, 11355, United States|Research Site, Mineola, New York, 11501, United States|Research Site, New Hyde Park, New York, 11042, United States|Research Site, New York, New York, 10029, United States|Research Site, Philadelphia, Pennsylvania, 19107-4824, United States|Research Site, Amarillo, Texas, 79106, United States|Research Site, Austin, Texas, 78731, United States|Research Site, Dallas, Texas, 75231, United States|Research Site, Edinburg, Texas, 78539, United States|Research Site, Mesquite, Texas, 74194, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, San Antonio, Texas, 78258, United States|Research Site, Bennington, Vermont, 05201, United States|Research Site, Federal Way, Washington, 98003, United States|Research Site, Buenos Aires, 1180AAX, Argentina|Research Site, Buenos Aires, C1405BCH, Argentina|Research Site, Caba, 1056, Argentina|Research Site, Cordoba, 5000, Argentina|Research Site, Cordoba, X5006IKK, Argentina|Research Site, Corrientes, 3400, Argentina|Research Site, Mar del Plata, B7600FZN, Argentina|Research Site, Ramos Mejía, B1704ETD, Argentina|Research Site, Brussels (Uccle), 1180, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Calgary, Alberta, T2V 4J2, Canada|Research Site, Edmonton, Alberta, T6G 2E1, Canada|Research Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Research Site, Cambridge, Ontario, N1R 7L6, Canada|Research Site, Hamilton, Ontario, L8N 3Z5, Canada|Research Site, Ottawa, Ontario, K1H 7W9, Canada|Research Site, Smiths Falls, Ontario, K7A 4W8, Canada|Research Site, Sherbrooke, Quebec, J1H 5N4, Canada|Research Site, Santiago, 7500010, Chile|Research Site, Santiago, 8053095, Chile|Research Site, Temuco, 4781156, Chile|Research Site, Dresden, 1307, Germany|Research Site, Essen, 45355, Germany|Research Site, Falkensee, 14612, Germany|Research Site, Freiburg im Breisgau, 79106, Germany|Research Site, Hamburg, 22607, Germany|Research Site, Heidelberg, 69115, Germany|Research Site, Oldenburg, 23758, Germany|Research Site, Pohlheim, 35415, Germany|Research Site, Saarlouis, 66740, Germany|Research Site, Sulzbach-Rosenberg, 92237, Germany|Research Site, Wangen, 88239, Germany|Research Site, Aki-gun, 735-0021, Japan|Research Site, Amagasaki-shi, 661-0002, Japan|Research Site, Chitose-shi, 066-0032, Japan|Research Site, Chuo-ku, 103-0002, Japan|Research Site, Fukuyama-shi, 721-0927, Japan|Research Site, Higashiosaka-shi, 577-0802, Japan|Research Site, Ibusuki-shi, 891-0401, Japan|Research Site, Kagoshima-shi, 892-0824, Japan|Research Site, Kamakura-shi, 247-0056, Japan|Research Site, Kashiwara-shi, 582-0005, Japan|Research Site, Kitakyushu-shi, 807-0857, Japan|Research Site, Koriyama-shi, 963-8851, Japan|Research Site, Kumamoto-shi, 862-0976, Japan|Research Site, Kurume-shi, 830-8543, Japan|Research Site, Miura-shi, 238-0101, Japan|Research Site, Nagoya-shi, 455-8530, Japan|Research Site, Obihiro-shi, 080-0016, Japan|Research Site, Oita-shi, 870-0855, Japan|Research Site, Osaka-shi, 530-0001, Japan|Research Site, Oyama-shi, 323-0022, Japan|Research Site, Sapporo-shi, 060-0001, Japan|Research Site, Shibuya-ku, 150-0013, Japan|Research Site, Shinjuku-ku, 169-0073, Japan|Research Site, Shizuoka-shi, 424-0855, Japan|Research Site, Tsukuba-shi, 305-0812, Japan|Research Site, Ushiku-shi, 300-1207, Japan|Research Site, Uwajima-shi, 798-8510, Japan|Research Site, Yokohama-shi, 231-8682, Japan|Research Site, Yokohama-shi, 235-0045, Japan|Research Site, Hoogeveen, 7909 AA, Netherlands|Research Site, Maastricht, 6020 AZ, Netherlands|Research Site, Utrecht, 3584 CX, Netherlands|Research Site, Białystok, 15-351, Poland|Research Site, Białystok, 15-435, Poland|Research Site, Gdańsk, 80-546, Poland|Research Site, Krakow, 31-501, Poland|Research Site, Kraków, 31-156, Poland|Research Site, Kraków, 31-261, Poland|Research Site, Lublin, 20-044, Poland|Research Site, Warsaw, 04736, Poland|Research Site, Wroclaw, 51-685, Poland|Research Site, Novosibirsk, 630091, Russian Federation|Research Site, Saint Petersburg, 199034, Russian Federation|Research Site, Saint-Petersburg, 194354, Russian Federation|Research Site, St. Petersburg, 191015, Russian Federation|Research Site, St.Petersburg, 194354, Russian Federation|Research Site, Göteborg, 413 45, Sweden|Research Site, Helsingborg, 25220, Sweden|Research Site, Linkoping, 587 58, Sweden|Research Site, Uddevalla, 451 80, Sweden|Research Site, Olten, 4600, Switzerland|Research Site, St. Gallen, 9016, Switzerland|Research Site, Zollikerberg, 8125, Switzerland|Research Site, Manchester, M23 9LT, United Kingdom|Research Site, Northampton, NN1 5BD, United Kingdom|Research Site, Oldham, OL1 2JH, United Kingdom|Research Site, Swansea, SA2 8QA, United Kingdom|Research Site, Wakefield, WF1 4DG, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02460978

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