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Clinical Trial Details

Trial ID: L4304
Source ID: NCT02547935
Associated Drug: Dapagliflozin 10 Mg
Title: A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02547935/results
Conditions: Type 2 Diabetes Mellitus, CKD and Albuminuria
Interventions: DRUG: Dapagliflozin 10 mg|DRUG: Saxagliptin 2.5 mg|DRUG: Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Outcome Measures: Primary: Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24, HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a mixed model repeated measures (MMRM) model., Baseline and Week 24|Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24, UACR was analysed at baseline and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. UACR values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24., Baseline and Week 24 | Secondary: Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24, Total body weight was measured in kilograms (kg) at baseline and at Week 1 then every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. Total body weight values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24., Baseline and Week 24|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, FPG was analysed at baseline and Week 1 then every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model., Baseline and Week 24|Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24, The percentage of patients meeting the criteria of at least a 30% reduction in UACR, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (Last Observation Carried Forward \[LOCF\])., From baseline up to Week 24|Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24, The percentage of patients meeting the criteria of a less than 7% reduction in HbA1c, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (LOCF). Only measurements prior to rescue or treatment discontinuation were analysed., From baseline to Week 24|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24, Seated SBP was analysed at baseline, Week 1 and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model., Baseline and Week 24|Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24, HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model., Baseline and Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 459
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-09-21
Completion Date: 2018-05-18
Results First Posted: 2019-06-04
Last Update Posted: 2019-08-21
Locations: Research Site, Peoria, Arizona, 85381, United States|Research Site, Chula Vista, California, 91910, United States|Research Site, Concord, California, 94520, United States|Research Site, El Centro, California, 92243, United States|Research Site, La Mesa, California, 92123, United States|Research Site, Long Beach, California, 90807, United States|Research Site, Los Gatos, California, 95032, United States|Research Site, North Hollywood, California, 91606, United States|Research Site, Riverside, California, 92505, United States|Research Site, San Diego, California, 92111, United States|Research Site, San Dimas, California, 91773, United States|Research Site, Hollywood, Florida, 33024, United States|Research Site, Miami, Florida, 33126, United States|Research Site, New Port Richey, Florida, 34652, United States|Research Site, Palm Harbor, Florida, 34684, United States|Research Site, Pompano Beach, Florida, 33060, United States|Research Site, Augusta, Georgia, 30909, United States|Research Site, Meridian, Idaho, 83642, United States|Research Site, Chicago, Illinois, 60643, United States|Research Site, Bangor, Maine, 04401, United States|Research Site, Kansas City, Missouri, 64111, United States|Research Site, Las Vegas, Nevada, 89148, United States|Research Site, Bronx, New York, 10459, United States|Research Site, Springfield Gardens, New York, 11413, United States|Research Site, Greensboro, North Carolina, 27408, United States|Research Site, Morehead City, North Carolina, 28557, United States|Research Site, Rocky Mount, North Carolina, 27804, United States|Research Site, Philadelphia, Pennsylvania, 19107, United States|Research Site, Greenville, South Carolina, 29605, United States|Research Site, Brownsville, Texas, 78520, United States|Research Site, Cypress, Texas, 77429, United States|Research Site, Houston, Texas, 77004, United States|Research Site, San Antonio, Texas, 78215, United States|Research Site, Sugar Land, Texas, 77479, United States|Research Site, Salt Lake City, Utah, 84124, United States|Research Site, Burke, Virginia, 22015, United States|Research Site, Richmond, Virginia, 23219, United States|Research Site, Box Hill, 3128, Australia|Research Site, Campbelltown, 2560, Australia|Research Site, Geelong, 3220, Australia|Research Site, Herston, 4029, Australia|Research Site, Winnipeg, Manitoba, R3E 3P4, Canada|Research Site, Moncton, New Brunswick, E1G 1A7, Canada|Research Site, Ajax, Ontario, L1Z 0M1, Canada|Research Site, Cambridge, Ontario, N1R 6V6, Canada|Research Site, Scarborough, Ontario, M1H 3G4, Canada|Research Site, Scarborough, Ontario, M1R 3A6, Canada|Research Site, Toronto, Ontario, M5C 2T2, Canada|Research Site, Chicoutimi, Quebec, G7H 7K9, Canada|Research Site, Saint-Jerome, Quebec, J7Z 5T3, Canada|Research Site, Sherbrooke, Quebec, J1H 5N4, Canada|Research Site, Quebec, G2J 0C4, Canada|Research Site, Chuo-ku, 103-0002, Japan|Research Site, Chuo-ku, 103-0027, Japan|Research Site, Chuo-ku, 103-0028, Japan|Research Site, Hachioji-shi, 192-0071, Japan|Research Site, Higashiosaka-shi, 577-0803, Japan|Research Site, Kisarazu-shi, 292-0038, Japan|Research Site, Kyoto-shi, 615-8125, Japan|Research Site, Neyagawa-shi, 572-0015, Japan|Research Site, Nishinomiya-shi, 663-8113, Japan|Research Site, Oita-shi, 870-0039, Japan|Research Site, Osaka-shi, 530-0001, Japan|Research Site, Osaka-shi, 559-0012, Japan|Research Site, Sendai-shi, 980-0021, Japan|Research Site, Shinjuku-ku, 160-0008, Japan|Research Site, Toyonaka-shi, 560-0082, Japan|Research Site, Ansan-si, 15355, Korea, Republic of|Research Site, Busan, 47392, Korea, Republic of|Research Site, Cheongju-si, 28644, Korea, Republic of|Research Site, Daejeon, 35015, Korea, Republic of|Research Site, Seongnam-si, 13620, Korea, Republic of|Research Site, Seoul, 02841, Korea, Republic of|Research Site, Seoul, 03080, Korea, Republic of|Research Site, Seoul, 06351, Korea, Republic of|Research Site, Suwon-si, 16499, Korea, Republic of|Research Site, Wonju-si, 26426, Korea, Republic of|Research Site, Aguascalientes, 20230, Mexico|Research Site, Guadalajara, 44160, Mexico|Research Site, Guadalajara, 44600, Mexico|Research Site, Guadalajara, 44670, Mexico|Research Site, Mexico, 03800, Mexico|Research Site, Mexico, 06726, Mexico|Research Site, Monterey, 64060, Mexico|Research Site, Monterrey, 64460, Mexico|Research Site, Monterrey, 64465, Mexico|Research Site, México, 03300, Mexico|Research Site, Queretaro, 76000, Mexico|Research Site, Zapopan, Jalisco, 45200, Mexico|Research Site, Zapopan, 45116, Mexico|Research Site, Benoni, 1501, South Africa|Research Site, Cape Town, 1730, South Africa|Research Site, Cape Town, 7925, South Africa|Research Site, Durban, 4092, South Africa|Research Site, Kuilsrivier, 7580, South Africa|Research Site, Mamelodi East, 0184, South Africa|Research Site, Muckleneuk, 0002, South Africa|Research Site, Paarl, 7646, South Africa|Research Site, Pretoria, 184, South Africa|Research Site, A Coruña, 15006, Spain|Research Site, Barcelona, 08035, Spain|Research Site, Madrid, 28046, Spain|Research Site, Sabadell (Barcelona), 08208, Spain|Research Site, Santiago(A Coruña), 15706, Spain|Research Site, Valencia, 46017, Spain|Research Site, Changhua, 500, Taiwan|Research Site, Kaohsiung Hsien, 83342, Taiwan|Research Site, New Taipei City, 23148, Taiwan|Research Site, New Taipei, Taiwan|Research Site, Taichung, 40705, Taiwan|Research Site, Taipei City, 112, Taiwan|Research Site, Yong-Kang City, 71004, Taiwan
URL: https://clinicaltrials.gov/show/NCT02547935

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details
D447 Saxagliptin small molecule DB06335 Details