Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7020
Source ID: NCT02413398
Associated Drug: Dapagliflozin 10 Mg
Title: A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
Acronym: DERIVE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02413398/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin 10 mg|DRUG: Matching Placebo for Dapagliflozin
Outcome Measures: Primary: Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24, To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24., Baseline, Week 24 | Secondary: Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24., To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" represents the number with change from baseline available at Week 24., Baseline, Week 24|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24., To compare the mean change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" represents the number with change from baseline available at Week 24., Baseline, Week 24|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24., To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" represents the number with change from baseline available at Week 24., Baseline, Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 321
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-06-15
Completion Date: 2017-11-07
Results First Posted: 2018-10-31
Last Update Posted: 2018-10-31
Locations: Research Site, Huntsville, Alabama, 35801, United States|Research Site, Burbank, California, 91505, United States|Research Site, Chula Vista, California, 91910, United States|Research Site, Concord, California, 94520, United States|Research Site, Fullerton, California, 92835-3404, United States|Research Site, Huntington Beach, California, 92648, United States|Research Site, Los Gatos, California, 95032, United States|Research Site, Newport Beach, California, 92663, United States|Research Site, Salinas, California, 93901-4446, United States|Research Site, Miami Springs, Florida, 33166, United States|Research Site, Miami, Florida, 33015, United States|Research Site, Miami, Florida, 33144, United States|Research Site, Pembroke Pines, Florida, 33027, United States|Research Site, Chicago, Illinois, 60643, United States|Research Site, Brownsburg, Indiana, 46112, United States|Research Site, Louisville, Kentucky, 40213, United States|Research Site, Monroe, Louisiana, 71203, United States|Research Site, Flint, Michigan, 48504, United States|Research Site, Jackson, Michigan, 39209, United States|Research Site, Chesterfield, Missouri, 63017, United States|Research Site, Kansas City, Missouri, 64111, United States|Research Site, Chapel Hill, North Carolina, 27517, United States|Research Site, Chattanooga, Tennessee, 37404, United States|Research Site, Houston, Texas, 77004, United States|Research Site, San Antonio, Texas, 78215, United States|Research Site, San Antonio, Texas, 78224, United States|Research Site, Manassas, Virginia, 20110, United States|Research Site, Blagoevgrad, 2700, Bulgaria|Research Site, Botevgrad, 2140, Bulgaria|Research Site, Kozloduy, 3320, Bulgaria|Research Site, Kyustendil, 2500, Bulgaria|Research Site, Sofia, 1233, Bulgaria|Research Site, Sofia, 1407, Bulgaria|Research Site, Sofia, 1606, Bulgaria|Research Site, Stara Zagora, 6000, Bulgaria|Research Site, Red Deer, Alberta, T4N 6V7, Canada|Research Site, Surrey, British Columbia, V3S 2N6, Canada|Research Site, Halifax, Nova Scotia, B3H 1V7, Canada|Research Site, Brampton, Ontario, L6S 0S9, Canada|Research Site, Cambridge, Ontario, N1R 6V6, Canada|Research Site, Concord, Ontario, L4K 4M2, Canada|Research Site, Courtice, Ontario, L1E 3C3, Canada|Research Site, Etobicoke, Ontario, M9R 4E1, Canada|Research Site, Guelph, Ontario, N1H 1B1, Canada|Research Site, London, Ontario, N6G 5A9, Canada|Research Site, North York, Ontario, M3J 1N2, Canada|Research Site, Oakville, Ontario, L6M 4H8, Canada|Research Site, Sudbury, Ontario, P3E 6C3, Canada|Research Site, Toronto, Ontario, M3M 0B2, Canada|Research Site, Toronto, Ontario, M4G 3E8, Canada|Research Site, Saskatoon, Saskatchewan, S7H 5M3, Canada|Research Site, Quebec, G1V 4G2, Canada|Research Site, Cheb, 350 02, Czechia|Research Site, Horovice, 268 01, Czechia|Research Site, Krnov, 794 01, Czechia|Research Site, Kutna Hora, 284 30, Czechia|Research Site, Ostrava, 702 00, Czechia|Research Site, Praha - Klanovice, 190 14, Czechia|Research Site, Praha 10, 104 00, Czechia|Research Site, Bari, 70124, Italy|Research Site, Bergamo, 24127, Italy|Research Site, Chieti Scalo, 66013, Italy|Research Site, Milano, 20122, Italy|Research Site, Napoli, 80138, Italy|Research Site, Padova, 35128, Italy|Research Site, Pisa, 56100, Italy|Research Site, San Giovanni Rotondo, 71013, Italy|Research Site, Bielsko-Biała, 43-300, Poland|Research Site, Bydgoszcz, 85-231, Poland|Research Site, Mrągowo, 11-700, Poland|Research Site, Ostrowiec Świętokrzyski, 27-400, Poland|Research Site, Tczew, 83-110, Poland|Research Site, Wrocław, 50-403, Poland|Research Site, Łódź, 90-132, Poland|Research Site, A Coruña, 15006, Spain|Research Site, Alicante, 03010, Spain|Research Site, Ferrol, 15405, Spain|Research Site, La Laguna (Tenerife), 38320, Spain|Research Site, Lérida, 25198, Spain|Research Site, Madrid, 28007, Spain|Research Site, Madrid, 28034, Spain|Research Site, Málaga, 29010, Spain|Research Site, Pozuelo de Alarcon, 28223, Spain|Research Site, Göteborg, 413 45, Sweden|Research Site, Lund, 221 85, Sweden|Research Site, Stockholm, 111 57, Sweden|Research Site, Stockholm, 11324, Sweden
URL: https://clinicaltrials.gov/show/NCT02413398

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details
D184 Simvastatin small molecule DB00641 Details