Clinical trial NCT05182840: A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
Official title: Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Disease, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 714
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study.

The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin.

In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine.

In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine.

Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call.

Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.


Eligibility criteria: Inclusion criteria

* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
* Male or female patients of legal adult age (according to local legislation) and aged ≥ 18 years at time of consent.
* estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) ≥ 30 and \< 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis.
* Urine Albumin Creatinine Ratio (UACR) ≥ 200 and \< 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1
* If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone ≤10 mg or equivalent).
* Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for ≥ 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial.
* In the Investigator's opinion, any kind of diagnosed chronic kidney disease (Diagnosis can be reached by standard clinical method, no biopsy required). Patients with diabetic kidney disease must have type 2 diabetes mellitus and their treatment (including GLP1 receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation.
* Glycated Haemoglobin (HbA1c) \< 10.0% at Visit 1 measured by the central laboratory.
* Serum potassium ≤ 4.8 mmol/L at Visit 1 measured by the central laboratory.
* Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 160 mmHg and Diastolic Blood Pressure (DBP) ≥ 65 and ≤ 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement.
* Body Mass Index (BMI) ≥ 18.5 and \< 50 kg/m2 at Visit 1.
* Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP.

Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period):

* Serum potassium ≤ 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
* eGFR (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) ≥ 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.

Exclusion criteria

* Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase.
* Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded.
* Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA))
* Patients at increased risk of ketoacidosis in the opinion of the investigator.
* Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial.

Further criteria apply.

Primary outcomes:
measure: 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
timeFrame: 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.
measure: Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients
timeFrame: 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.
measure: Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin
timeFrame: 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.
measure: 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
timeFrame: 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 outcomes:
measure: 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
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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)
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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)
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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)
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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)
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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
timeFrame: 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.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
measure: 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
timeFrame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Aventiv Research Inc.
state: Arizona
city: Phoenix
country: United States
facility: AKDHC Medical Research Services, LLC
state: Arizona
city: Canyon Country
country: United States
facility: Clearview Medical Research, LLC
state: California
city: Long Beach
country: United States
facility: Pacific Renal Associates
state: California
city: Northridge
country: United States
facility: Amicis Research Center
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: San Dimas
country: United States
facility: California Kidney Specialists
state: California
city: Denver
country: United States
facility: Colorado Kidney Care
state: Colorado
city: Brandon
country: United States
facility: Clinical Research of Brandon LLC
state: Florida
city: Coral Gables
country: United States
facility: Horizon Research Group
state: Florida
city: Fort Lauderdale
country: United States
facility: Elixia Fort Lauderdale, LLC
state: Florida
city: Lauderdale Lakes
country: United States
facility: South Florida Research Institute
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Total Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Horizon Research Group, LLC
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center
state: Florida
city: Temple Terrace
country: United States
facility: Elixia Tampa, LLC
state: Florida
city: Nampa
country: United States
facility: Boise Kidney and Hypertension PLLC
state: Idaho
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Wichita
country: United States
facility: Kansas Nephrology Research Institute, LLC
state: Kansas
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Flint
country: United States
facility: Elite Research Center, LLC
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Forte Family Practice
state: Nevada
city: Albuquerque
country: United States
facility: New Mexico Clinical Research and Osteoporosis Center, Inc.
state: New Mexico
city: Asheboro
country: United States
facility: Triad Internal Medicine
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Canton
country: United States
facility: Diabetes & Endocrinology Associates of Stark County
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Beaver
country: United States
facility: Heritage Valley Medical Group
state: Pennsylvania
city: Upland
country: United States
facility: Elixia Upland, LLC
state: Pennsylvania
city: Rapid City
country: United States
facility: Monument Health
state: South Dakota
city: Knoxville
country: United States
facility: Knoxville Kidney Center PLLC
state: Tennessee
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: El Paso
country: United States
facility: Academy Of Diabetes, Thyroid And Endocrine, PA
state: Texas
city: Houston
country: United States
facility: PrimeCare Medical Group
state: Texas
city: Lufkin
country: United States
facility: P&I Clinical Research, LLC
state: Texas
city: Sugar Land
country: United States
facility: Simcare Medical Research, LLC
state: Texas
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
city: Tacoma
country: United States
facility: Universal Research Group, LLC
state: Washington
city: Buenos Aires
country: Argentina
facility: CIMEL centro de Investigaciones Médicas Lanús
city: Caba
country: Argentina
facility: CEDIC - Centro de Investigacion Clinica
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Glenny Corp. S.A. Bioclinica Argentina
city: Cordoba
country: Argentina
facility: Instituto Privado de Investigaciones Clínica Córdoba S.A.
city: Junín
country: Argentina
facility: Centro de Salud Renal Junín
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Médicas Mar del Plata
city: Rosario
country: Argentina
facility: Instituto Médico Catamarca - IMEC
city: Villa Luro
country: Argentina
facility: CEMEDIC - Centro de Especialidades Medicas
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Monash University
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Brussel
country: Belgium
facility: Brussels - UNIV UZ Brussel
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: La Louvière
country: Belgium
facility: La Louvière - UNIV CHU Tivoli
city: Leuven/Vlaams-Brabant
country: Belgium
facility: UZ Leuven
city: Lodelinsart
country: Belgium
facility: Charleroi - UNIV CHU de Charleroi
city: Belém
country: Brazil
facility: Hospital Universitário João de Barros Barreto
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu - UNESP
city: Curitiba
country: Brazil
facility: Fundação Pró Renal Brasil
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica
city: Sao Paulo
country: Brazil
facility: BR Trials
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clinica - CPCLIN
city: São Bernardo do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos
city: São Paulo
country: Brazil
facility: Hospital do RIM - UNIFESP
city: Ruse
country: Bulgaria
facility: Medical Center Rusemed
city: Sofia
country: Bulgaria
facility: Robert Koch Clinic Sofia
city: Sofia
country: Bulgaria
facility: Medical Center Synexus Sofia EOOD
city: Stara Zagora
country: Bulgaria
facility: MHAT Prof Stoyan Kirkovich AD
city: Red Deer
country: Canada
facility: The Bailey Clinic
state: Alberta
city: Brampton
country: Canada
facility: LMC Clinical Research Inc. (Brampton)
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Waterloo
country: Canada
facility: Sameh Fikry Medicine Professional Corporation
state: Ontario
city: Waterloo
country: Canada
facility: Shivinder Jolly, Nephrologist
state: Ontario
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: The First Afiliated Hospital, Sun Yet-sen University
city: Hangzhou
country: China
facility: Zhejiang Province People's Hospital
city: Nanning
country: China
facility: The First People's Hospital of Nanning
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital affiliated to Fudan University
city: Havirov
country: Czechia
facility: DIKa centrum s.r.o.
city: Prague
country: Czechia
facility: Synexus Czech s.r.o.
city: Pribram
country: Czechia
facility: MILAN KVAPIL s.r.o.
city: Slany
country: Czechia
facility: Hospital Slany, Internal Department
city: Kuopio
country: Finland
facility: Satucon Oy
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital / TYKS
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
city: Berlin
country: Germany
facility: Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH
city: Dresden
country: Germany
facility: Cardiologicum Dresden und Pirna
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Düsseldorf
country: Germany
facility: DaVita Clinical Research Germany GmbH
city: Frankfurt
country: Germany
facility: Synexus Clinical Research GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Synexus Clinical Research GmbH
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg AÖR
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
city: Athens
country: Greece
facility: "Attiko" Hospital of Athens
city: Ioannina
country: Greece
facility: Univ. Gen. Hosp. of Ioannina
city: P. Faliro
country: Greece
facility: Iatriko of Athens Group/ Iatriko of P. Faliro
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Baja
country: Hungary
facility: Lausmed Kft. Outpatient Unit of Internal Medicine
city: Balatonfured
country: Hungary
facility: DRC Drug Research Ltd
city: Budapest
country: Hungary
facility: Synexus Hungary Healthcare Service Ltd.
city: Budapest
country: Hungary
facility: Semmelweis University
city: Debrecen
country: Hungary
facility: University Debrecen Hospital
city: Eger
country: Hungary
facility: Markhot Ferenc Hospital, Eger
city: Hatvan
country: Hungary
facility: BKS Research Ltd
city: Aurangabad
country: India
facility: Government Medical College & Hospital
city: Jaipur
country: India
facility: SMS Medical College and HospitaL
city: Jaipur
country: India
facility: Jaipur National University Institute for Medical Science & Research Centre
city: Kanpur
country: India
facility: Ganesh Shankar Vidyarthi Memorial Medical College
city: Mysore
country: India
facility: K R Hospital Mysore Medical College and Research Centre
city: Nagpur
country: India
facility: Kingsway Hospitals
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
city: Varanasi
country: India
facility: Galaxy Lifecare Services Pvt. Ltd.
city: Vellore
country: India
facility: Christian Medical College
city: Bari
country: Italy
facility: A.O. Policlinico Giovanni XXIII di Bari
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
city: Aichi, Ichinomiya
country: Japan
facility: Daiyukai Clinic
city: Aichi, Nagoya
country: Japan
facility: Meitetsu Hospital
city: Aichi, Nagoya
country: Japan
facility: Nagoya Kyoritsu Hospital
city: Aichi, Nagoya
country: Japan
facility: TOSAKI Clinic for Diabetes and Endocrinology
city: Gumma, Takasaki
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
city: Kyoto, Kuse-gun
country: Japan
facility: Kyoto Okamoto Memorial Hospital
city: Nagano, Ina
country: Japan
facility: Ina Central Hospital
city: Nagano, Suwa
country: Japan
facility: Suwa Red Cross Hospital
city: Saitama, Kawagoe
country: Japan
facility: Asano Clinic
city: Shiga, Omihachiman
country: Japan
facility: Omihachiman Community Medical Center
city: Tokyo, Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo, Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Tokyo, Shinagawa-ku
country: Japan
facility: Miho Clinic
city: Ueda, Nagano
country: Japan
facility: Yamaura Medical Clinic
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Cheongiu
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Cheras, Kuala Lumpur
country: Malaysia
facility: University Kebangsaan Malaysia
city: Johor Bahru
country: Malaysia
facility: Klinik Kesihatan Mahmoodiah
city: Kangar
country: Malaysia
facility: Tuanku Fauziah Hospital
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II, Kota Bharu
city: Seri Manjung
country: Malaysia
facility: Hospital Seri Manjung
city: Aguascalientes
country: Mexico
facility: Centro de Investigacion Cardiometabolica de Aguascalientes
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clinica y Atencion Medica HEPA SC
city: Mexico
country: Mexico
facility: Centro Mexicano de Desarrollo de Estudios Clínicos SA -CEMDEC
city: Mexico
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
city: México
country: Mexico
facility: Clinstile S.A. de C.V.
city: México
country: Mexico
facility: CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc
city: Nuevo León
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Nordbyhagen
country: Norway
facility: Akershus Universitetssykehus HF
city: Stavanger
country: Norway
facility: Helse Stavanger, Stavanger Universitetssykehus
city: Cebu City
country: Philippines
facility: Norzel Medical and Diagnostic Clinic
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Iloilo City
country: Philippines
facility: West Visayas State University Medical Center
city: Marikina city
country: Philippines
facility: Institute for Studies on Diabetes Foundation Inc.
city: Pasig City
country: Philippines
facility: The Medical City
city: Quezon City
country: Philippines
facility: Philippine Heart Center
city: Tarlac
country: Philippines
facility: Senor Santo Nino Hospital
city: Bydgoszcz
country: Poland
facility: INTERCORE Medical Center
city: Gdansk
country: Poland
facility: Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice
city: Katowice
country: Poland
facility: Pro Familia Altera
city: Lodz
country: Poland
facility: Synexus Lodz Medical Center
city: Lublin
country: Poland
facility: Clinical Best Solutions
city: Lublin
country: Poland
facility: NZOZ Specialized Ambulance "MEDICA"
city: Pomorskie
country: Poland
facility: Hospitals of Tczew S.A.
city: Poznan
country: Poland
facility: Omedica Medical Centre, Poznan
city: Poznan
country: Poland
facility: Synexus Poland, Branch in Poznan
city: Poznan
country: Poland
facility: Medical Center HCP Sp. z o.o
city: Warszawa
country: Poland
facility: Centrum Medyczne Synexus
city: Warszawa
country: Poland
facility: Barwijuk Clinics
city: Wroclaw
country: Poland
facility: Synexus Poland, Branch in Wroclaw
city: Almada
country: Portugal
facility: ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta
city: Aveiro
country: Portugal
facility: ULS da Região de Aveiro
city: Carnaxide
country: Portugal
facility: CHLO, EPE - Hospital de Santa Cruz
city: Leiria
country: Portugal
facility: ULS da Região de Leiria, E.P.E.
city: Lisboa
country: Portugal
facility: APDP - Associação Protectora dos Diabéticos de Portugal
city: Vila Nova de Gaia
country: Portugal
facility: ULS de Gaia/Espinho, EPE
city: Bloemfontein
country: South Africa
facility: Iatros International
city: Cape Town
country: South Africa
facility: Synexus Helderberg Clinical Research Centre
city: Cape Town
country: South Africa
facility: TREAD Research
city: Cape Town
country: South Africa
facility: Langeberg Clinical Trials
city: Cape Town
country: South Africa
facility: Paarl Research Centre
city: Durban
country: South Africa
facility: Latiff, GHVM
city: Krugersdorp
country: South Africa
facility: DJW Navorsing
city: Pretoria
country: South Africa
facility: Synexus Watermeyer Clinical Research Centre
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Burela
country: Spain
facility: Hospital Público Da Mariña
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
city: Kristianstad
country: Sweden
facility: Centralsjukhuset, Kristianstad
city: Linköping
country: Sweden
facility: Universitetssjukhuset, Linköping
city: Stockholm
country: Sweden
facility: Citydiabetes, Stockholm
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
References: