| Outcome Measures: |
Primary: Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients, The adjusted mean change (95% confidence interval) in log transformed FMV UACR from baseline at 14 weeks is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient., The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.|Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients, Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for all patients is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient., The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.|Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin, The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient., The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.|Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin, Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient., The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.|Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin, The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of empagliflozin in the Run-in period is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient., The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.|Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin, Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of empagliflozin in the Run-in period is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient., The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period. | Secondary: UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation, Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder, Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF), Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis, Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation, Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder, Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF), Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis, Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation, Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder, Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward, Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.|UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis, Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation, Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 week. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder, Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF), Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis, Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation, Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder, Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF), Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation, Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder, Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward, Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14., UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis, Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.|UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis, Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available., At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
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| Locations: |
Aventiv Research Inc., Mesa, Arizona, 85206, United States|AKDHC Medical Research Services, LLC, Phoenix, Arizona, 85027, United States|Clearview Medical Research, LLC, Canyon Country, California, 91351, United States|Pacific Renal Associates, Long Beach, California, 90806, United States|Amicis Research Center, Northridge, California, 91324, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|California Kidney Specialists, San Dimas, California, 91773, United States|Colorado Kidney Care, Denver, Colorado, 80230, United States|Clinical Research of Brandon LLC, Brandon, Florida, 33511, United States|Horizon Research Group, Coral Gables, Florida, 33134, United States|Elixia Fort Lauderdale, LLC, Fort Lauderdale, Florida, 33308, United States|South Florida Research Institute, Lauderdale Lakes, Florida, 33313, United States|San Marcus Research Clinic, Inc., Miami, Florida, 33014, United States|Total Research Group, LLC, Miami, Florida, 33126, United States|Horizon Research Group, LLC, Miami, Florida, 33150, United States|West Orange Endocrinology, Ocoee, Florida, 34761, United States|Pines Care Research Center, Pembroke Pines, Florida, 33024, United States|Elixia Tampa, LLC, Temple Terrace, Florida, 33637, United States|Boise Kidney and Hypertension PLLC, Nampa, Idaho, 83687, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|Kansas Nephrology Research Institute, LLC, Wichita, Kansas, 67214, United States|Aa Mrc Llc, Flint, Michigan, 48504, United States|Elite Research Center, LLC, Flint, Michigan, 48532, United States|Clinical Research Consultants, LLC, Kansas City, Missouri, 64111, United States|Forte Family Practice, Las Vegas, Nevada, 89103, United States|New Mexico Clinical Research and Osteoporosis Center, Inc., Albuquerque, New Mexico, 87106, United States|Triad Internal Medicine, Asheboro, North Carolina, 27203, United States|Lucas Research, Inc., Morehead City, North Carolina, 28557, United States|Diabetes & Endocrinology Associates of Stark County, Canton, Ohio, 44718, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Heritage Valley Medical Group, Beaver, Pennsylvania, 15009, United States|Elixia Upland, LLC, Upland, Pennsylvania, 19013, United States|Monument Health, Rapid City, South Dakota, 57701, United States|Knoxville Kidney Center PLLC, Knoxville, Tennessee, 37923, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Academy Of Diabetes, Thyroid And Endocrine, PA, El Paso, Texas, 79935, United States|PrimeCare Medical Group, Houston, Texas, 77024, United States|P&I Clinical Research, LLC, Lufkin, Texas, 75904, United States|Simcare Medical Research, LLC, Sugar Land, Texas, 77478, United States|Providence Medical Research Center, Spokane, Washington, 99204, United States|Universal Research Group, LLC, Tacoma, Washington, 98405, United States|CIMEL centro de Investigaciones Médicas Lanús, Buenos Aires, B1824KAJ, Argentina|CEDIC - Centro de Investigacion Clinica, Caba, C1060ABN, Argentina|Glenny Corp. S.A. Bioclinica Argentina, Ciudad Autonoma Buenos Aires, C1430CKE, Argentina|Instituto Privado de Investigaciones Clínica Córdoba S.A., Cordoba, X5000AAW, Argentina|Centro de Salud Renal Junín, Junín, B6000GMA, Argentina|Centro de Investigaciones Médicas Mar del Plata, Mar del Plata, B7600FYK, Argentina|Instituto Médico Catamarca - IMEC, Rosario, S2000AJU, Argentina|CEMEDIC - Centro de Especialidades Medicas, Villa Luro, C1440CFD, Argentina|John Hunter Hospital, New Lambton Heights, New South Wales, 2305, Australia|Monash University, Box Hill, Victoria, 3128, Australia|St Vincent's Hospital Melbourne, Fitzroy, Victoria, 3065, Australia|Brussels - UNIV UZ Brussel, Brussel, 1090, Belgium|Brussels - UNIV Saint-Luc, Bruxelles, 1200, Belgium|La Louvière - UNIV CHU Tivoli, La Louvière, 7100, Belgium|UZ Leuven, Leuven/Vlaams-Brabant, 3000, Belgium|Charleroi - UNIV CHU de Charleroi, Lodelinsart, 6042, Belgium|Hospital Universitário João de Barros Barreto, Belém, CEP 66073-, Brazil|Faculdade de Medicina de Botucatu - UNESP, Botucatu, 18618-687, Brazil|Fundação Pró Renal Brasil, Curitiba, 80440-020, Brazil|Universidade Federal do Rio Grande do Sul, Porto Alegre, 90430-001, Brazil|Ruschel Medicina e Pesquisa Clínica, Rio de Janeiro, 22270-060, Brazil|BR Trials, Sao Paulo, 01236-030, Brazil|Centro de Pesquisa Clinica - CPCLIN, Sao Paulo, 01244-030, Brazil|CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo, 09780-000, Brazil|Hospital do RIM - UNIFESP, São Paulo, 04023-062, Brazil|Medical Center Rusemed, Ruse, 7013, Bulgaria|Robert Koch Clinic Sofia, Sofia, 1407, Bulgaria|Medical Center Synexus Sofia EOOD, Sofia, 1784, Bulgaria|MHAT Prof Stoyan Kirkovich AD, Stara Zagora, 6000, Bulgaria|The Bailey Clinic, Red Deer, Alberta, T4N 6V7, Canada|LMC Clinical Research Inc. (Brampton), Brampton, Ontario, L6S 0C6, Canada|Toronto General Hospital, Toronto, Ontario, M5G 2N2, Canada|Sameh Fikry Medicine Professional Corporation, Waterloo, Ontario, N2J 1C4, Canada|Shivinder Jolly, Nephrologist, Waterloo, Ontario, N2T 0C1, Canada|Recherche GCP Research, Montreal, Quebec, H1M 1B1, Canada|Guangdong Provincial People's Hospital, Guangzhou, 510080, China|The First Afiliated Hospital, Sun Yet-sen University, Guangzhou, 510080, China|Zhejiang Province People's Hospital, Hangzhou, 310014, China|The First People's Hospital of Nanning, Nanning, 530000, China|Huashan Hospital, Fudan University, Shanghai, 200040, China|Shanghai Fifth People's Hospital affiliated to Fudan University, Shanghai, 200240, China|DIKa centrum s.r.o., Havirov, 73601, Czechia|Synexus Czech s.r.o., Prague, 120 00, Czechia|MILAN KVAPIL s.r.o., Pribram, 26101, Czechia|Hospital Slany, Internal Department, Slany, 274 01, Czechia|Satucon Oy, Kuopio, 70100, Finland|Tampere University Hospital, Tampere, 33521, Finland|Turku University Hospital / TYKS, Turku, 20520, Finland|Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Bad Oeynhausen, 32545, Germany|Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH, Berlin, 10437, Germany|Cardiologicum Dresden und Pirna, Dresden, 01277, Germany|Universitätsklinikum Carl Gustav Carus Dresden, Dresden, 01307, Germany|DaVita Clinical Research Germany GmbH, Düsseldorf, 40210, Germany|Synexus Clinical Research GmbH, Frankfurt, 60313, Germany|Medizinische Hochschule Hannover, Hannover, 30625, Germany|Synexus Clinical Research GmbH, Leipzig, 04103, Germany|Universitätsklinikum Würzburg AÖR, Würzburg, 97080, Germany|General Hospital of Athens "Laiko", Athens, 115 27, Greece|"Attiko" Hospital of Athens, Athens, 124 62, Greece|Univ. Gen. Hosp. of Ioannina, Ioannina, 455 00, Greece|Iatriko of Athens Group/ Iatriko of P. Faliro, P. Faliro, 17562, Greece|Prince of Wales Hospital, Hong Kong, 999077, Hong Kong|Queen Mary Hospital, Hong Kong, Hong Kong|Lausmed Kft. Outpatient Unit of Internal Medicine, Baja, 6500, Hungary|DRC Drug Research Ltd, Balatonfured, 8230, Hungary|Synexus Hungary Healthcare Service Ltd., Budapest, 1036, Hungary|Semmelweis University, Budapest, 1083, Hungary|University Debrecen Hospital, Debrecen, 4032, Hungary|Markhot Ferenc Hospital, Eger, Eger, 3300, Hungary|BKS Research Ltd, Hatvan, 3000, Hungary|Government Medical College & Hospital, Aurangabad, 431001, India|SMS Medical College and HospitaL, Jaipur, 302001, India|Jaipur National University Institute for Medical Science & Research Centre, Jaipur, 302017, India|Ganesh Shankar Vidyarthi Memorial Medical College, Kanpur, 208002, India|K R Hospital Mysore Medical College and Research Centre, Mysore, 570001, India|Kingsway Hospitals, Nagpur, 440001, India|All India Institute of Medical Sciences, New Delhi, 110029, India|Shree Giriraj Multispeciality Hospital, Rajkot, 360005, India|Galaxy Lifecare Services Pvt. Ltd., Varanasi, 221010, India|Christian Medical College, Vellore, 632004, India|A.O. Policlinico Giovanni XXIII di Bari, Bari, 70124, Italy|ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII, Bergamo, 24127, Italy|Daiyukai Clinic, Aichi, Ichinomiya, 491-8551, Japan|Meitetsu Hospital, Aichi, Nagoya, 451-8511, Japan|Nagoya Kyoritsu Hospital, Aichi, Nagoya, 454-0933, Japan|TOSAKI Clinic for Diabetes and Endocrinology, Aichi, Nagoya, 468-0009, Japan|National Hospital Organization Takasaki General Medical Center, Gumma, Takasaki, 370-0829, Japan|Kyoto Okamoto Memorial Hospital, Kyoto, Kuse-gun, 613-0034, Japan|Ina Central Hospital, Nagano, Ina, 396-8555, Japan|Suwa Red Cross Hospital, Nagano, Suwa, 392-8510, Japan|Asano Clinic, Saitama, Kawagoe, 350-0851, Japan|Omihachiman Community Medical Center, Shiga, Omihachiman, 523-0082, Japan|The University of Tokyo Hospital, Tokyo, Bunkyo-ku, 113-8655, Japan|Tokyo Medical University Hachioji Medical Center, Tokyo, Hachioji, 193-0998, Japan|Miho Clinic, Tokyo, Shinagawa-ku, 141-0032, Japan|Yamaura Medical Clinic, Ueda, Nagano, 386-0407, Japan|Korea University Ansan Hospital, Ansan, 15355, Korea, Republic of|Chungbuk National University Hospital, Cheongiu, 28644, Korea, Republic of|Inje University Ilsan Paik Hospital, Goyang, 10380, Korea, Republic of|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Severance Hospital, Seoul, 03722, Korea, Republic of|SMG-SNU Boramae Medical Center, Seoul, 156-707, Korea, Republic of|Hospital Selayang, Batu Caves, 68100, Malaysia|University Kebangsaan Malaysia, Cheras, Kuala Lumpur, 56000, Malaysia|Klinik Kesihatan Mahmoodiah, Johor Bahru, 80100, Malaysia|Tuanku Fauziah Hospital, Kangar, 01000, Malaysia|Hospital Raja Perempuan Zainab II, Kota Bharu, Kota Bharu, 15200, Malaysia|Hospital Seri Manjung, Seri Manjung, 32040, Malaysia|Centro de Investigacion Cardiometabolica de Aguascalientes, Aguascalientes, 20230, Mexico|Unidad de Investigación Clinica y Atencion Medica HEPA SC, Guadalajara, 44670, Mexico|Centro Mexicano de Desarrollo de Estudios Clínicos SA -CEMDEC, Mexico, 06100, Mexico|Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V., Mexico, 20010, Mexico|Clinstile S.A. de C.V., México, 06700, Mexico|CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc, México, 11650, Mexico|Hospital Universitario Dr Jose Eleuterio Gonzalez, Nuevo León, 64460, Mexico|Akershus Universitetssykehus HF, Nordbyhagen, 1478, Norway|Helse Stavanger, Stavanger Universitetssykehus, Stavanger, 4011, Norway|Norzel Medical and Diagnostic Clinic, Cebu City, 6000, Philippines|Davao Doctors Hospital, Davao City, 8000, Philippines|West Visayas State University Medical Center, Iloilo City, 5000, Philippines|Institute for Studies on Diabetes Foundation Inc., Marikina city, 1810, Philippines|The Medical City, Pasig City, 1605, Philippines|Philippine Heart Center, Quezon City, 850, Philippines|Senor Santo Nino Hospital, Tarlac, 2306, Philippines|INTERCORE Medical Center, Bydgoszcz, 85-605, Poland|Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk, Gdansk, 80-382, Poland|Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice, Katowice, 40-040, Poland|Pro Familia Altera, Katowice, 40-648, Poland|Synexus Lodz Medical Center, Lodz, 90127, Poland|Clinical Best Solutions, Lublin, 20-078, Poland|NZOZ Specialized Ambulance "MEDICA", Lublin, 20-538, Poland|Hospitals of Tczew S.A., Pomorskie, 83-110, Poland|Omedica Medical Centre, Poznan, Poznan, 60-111, Poland|Synexus Poland, Branch in Poznan, Poznan, 60-702, Poland|Medical Center HCP Sp. z o.o, Poznan, 61-485, Poland|Centrum Medyczne Synexus, Warszawa, 02-672, Poland|Barwijuk Clinics, Warszawa, 02-884, Poland|Synexus Poland, Branch in Wroclaw, Wroclaw, 50-088, Poland|ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta, Almada, 2801-951, Portugal|ULS da Região de Aveiro, Aveiro, 3810-164, Portugal|CHLO, EPE - Hospital de Santa Cruz, Carnaxide, 2790-134, Portugal|ULS da Região de Leiria, E.P.E., Leiria, 2410-197, Portugal|APDP - Associação Protectora dos Diabéticos de Portugal, Lisboa, 1250-189, Portugal|ULS de Gaia/Espinho, EPE, Vila Nova de Gaia, 4434-502, Portugal|Iatros International, Bloemfontein, 9324, South Africa|Synexus Helderberg Clinical Research Centre, Cape Town, 7130, South Africa|TREAD Research, Cape Town, 7500, South Africa|Langeberg Clinical Trials, Cape Town, 7570, South Africa|Paarl Research Centre, Cape Town, 7646, South Africa|Latiff, GHVM, Durban, 4001, South Africa|DJW Navorsing, Krugersdorp, 1739, South Africa|Synexus Watermeyer Clinical Research Centre, Pretoria, 0184, South Africa|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Hospital Público Da Mariña, Burela, 27880, Spain|Hospital Universitario Reina Sofía, Córdoba, 14004, Spain|Fundación Jiménez Díaz, Madrid, 28040, Spain|Hospital Puerta de Hierro, Majadahonda, 28222, Spain|Centralsjukhuset, Kristianstad, Kristianstad, 291 33, Sweden|Universitetssjukhuset, Linköping, Linköping, 581 85, Sweden|Citydiabetes, Stockholm, Stockholm, 112 21, Sweden|University Hospital of Lausanne, Lausanne, 1011, Switzerland|Istanbul University, Istanbul, 34093, Turkey
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