BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131676
• Other study ID #: 1245.25
• Secondary ID: 2009-016178-33
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2010
• Last updated: February 11, 2016
• Start date: July 2010
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia MedicaAustralia: Responsible Ethics CommitteeAustria: Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicinal and Health ProductsBrazil: National Health Surveillance AgencyCanada: Health CanadaColombia: Instituto Nacional de Vigilancia de Medicamentos y AlimentosCroatia: Agency for Medicinal Product and Medical DevicesCzech Republic: State Institute for Drug ControlDenmark: The Danish Health and Medicines AuthorityEstonia: The State Agency of MedicineFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Georgia: Ministry of HealthGreece: Ethics CommitteeHong Kong: Department of HealthHungary: National Institute of PharmacyIndia: Drugs Controller General of IndiaIndonesia: National Agency of Drug and Food ControlIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ethics CommitteeJapan: Ministry of Health, Labor and WelfareMalaysia: Ministry of HealthMexico: Federal Commission for Protection Against Health RisksNetherlands: Central Committee Research Involving Human SubjectsNew Zealand: MedsafeNorway: Norwegian Medicines AgencyPeru: General Directorate of Pharmaceuticals, Devices, and DrugsPhilippines: Bureau of Food and DrugsPoland: Registration Medicinal Product Medical Device Biocidal ProductPortugal: National Pharmacy and Medicines InstituteRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSingapore: Health Sciences AuthoritySouth Africa: Medicines Control CouncilSouth Korea: Ministry of Food and Drug Safety (MFDS)Spain: Spanish Agency of MedicinesSri Lanka: Ministry of Healthcare and NutritionTaiwan : Food and Drug AdministrationThailand: Food and Drug AdministrationUkraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7064
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent

2. Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization.

3. Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients

4. Age >= 18 years

5. Body Mass index <= 45 at Visit 1

6. Signed and dated informed consent

7. High cardiovascular risk

Exclusion criteria:

1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)

2. Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.

3. Planned cardiac surgery or angioplasty within 3 months

4. Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.

5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption

6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)

7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years

8. Contraindications to background therapy according to the local label

9. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight

10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus

11. Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) who:

• are nursing or pregnant or

• are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner

12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake

13. Participation in another trial with an investigational drug within 30 days prior to informed consent

14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• BI 10773 low dose
BI 10773 tablets once daily
• Placebo BI 10773 high dose
Placebo tablets identical to BI 10773
• BI 10773 high dose
BI 10773 tablets once daily
• Placebo BI 10773 low dose
Placebo tablets identical to BI 10773
• Placebo BI 10773 low dose
Placebo tablets identical to BI 10773
• Placebo BI 10773 high dose
Placebo tablets identical to BI 10773

Locations

Country	Name	City	State
Argentina	1245.25.54012 Boehringer Ingelheim Investigational Site	Buenos Aires
Argentina	1245.25.54001 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1245.25.54006 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1245.25.54013 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1245.25.54010 Boehringer Ingelheim Investigational Site	Cordoba
Argentina	1245.25.54011 Boehringer Ingelheim Investigational Site	Cordoba
Argentina	1245.25.54002 Boehringer Ingelheim Investigational Site	Córdoba
Argentina	1245.25.54003 Boehringer Ingelheim Investigational Site	Córdoba
Argentina	1245.25.54005 Boehringer Ingelheim Investigational Site	Parque Velez Sarfield
Argentina	1245.25.54008 Boehringer Ingelheim Investigational Site	Rosario
Argentina	1245.25.54009 Boehringer Ingelheim Investigational Site	Rosario
Australia	1245.25.61001 Boehringer Ingelheim Investigational Site	Ashford	South Australia
Australia	1245.25.61002 Boehringer Ingelheim Investigational Site	Fullarton	South Australia
Australia	1245.25.61003 Boehringer Ingelheim Investigational Site	Herston	Queensland
Austria	1245.25.43008 Boehringer Ingelheim Investigational Site	Feldkirch
Austria	1245.25.43006 Boehringer Ingelheim Investigational Site	Graz
Austria	1245.25.43016 Boehringer Ingelheim Investigational Site	Innsbruck
Austria	1245.25.43005 Boehringer Ingelheim Investigational Site	Salzburg
Austria	1245.25.43015 Boehringer Ingelheim Investigational Site	St. Stefan
Austria	1245.25.43001 Boehringer Ingelheim Investigational Site	Wien
Austria	1245.25.43007 Boehringer Ingelheim Investigational Site	Wien
Austria	1245.25.43009 Boehringer Ingelheim Investigational Site	Wien
Austria	1245.25.43010 Boehringer Ingelheim Investigational Site	Wien
Austria	1245.25.43013 Boehringer Ingelheim Investigational Site	Wien
Belgium	1245.25.32010 Boehringer Ingelheim Investigational Site	Bonheiden
Belgium	1245.25.32030 Boehringer Ingelheim Investigational Site	Brussel
Belgium	1245.25.32008 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1245.25.32011 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1245.25.32003 Boehringer Ingelheim Investigational Site	De Pinte
Belgium	1245.25.32002 Boehringer Ingelheim Investigational Site	Edegem
Belgium	1245.25.32004 Boehringer Ingelheim Investigational Site	Genk
Belgium	1245.25.32029 Boehringer Ingelheim Investigational Site	Halen
Belgium	1245.25.32009 Boehringer Ingelheim Investigational Site	Hasselt
Belgium	1245.25.32007 Boehringer Ingelheim Investigational Site	Huy
Belgium	1245.25.32013 Boehringer Ingelheim Investigational Site	La Louvière
Belgium	1245.25.32012 Boehringer Ingelheim Investigational Site	Leuven
Belgium	1245.25.32001 Boehringer Ingelheim Investigational Site	Liège
Belgium	1245.25.32028 Boehringer Ingelheim Investigational Site	Liège
Belgium	1245.25.32005 Boehringer Ingelheim Investigational Site	Massemen-Wetteren
Belgium	1245.25.32014 Boehringer Ingelheim Investigational Site	Oostham
Brazil	1245.25.55014 Boehringer Ingelheim Investigational Site	Belém
Brazil	1245.25.55019 Boehringer Ingelheim Investigational Site	Belo Horizonte
Brazil	1245.25.55007 Boehringer Ingelheim Investigational Site	Boqueirão
Brazil	1245.25.55015 Boehringer Ingelheim Investigational Site	Brasília
Brazil	1245.25.55027 Boehringer Ingelheim Investigational Site	Campinas
Brazil	1245.25.55028 Boehringer Ingelheim Investigational Site	Campinas
Brazil	1245.25.55025 Boehringer Ingelheim Investigational Site	Curitiba
Brazil	1245.25.55026 Boehringer Ingelheim Investigational Site	Fortaleza
Brazil	1245.25.55009 Boehringer Ingelheim Investigational Site	Goiânia
Brazil	1245.25.55002 Boehringer Ingelheim Investigational Site	Higienópolis
Brazil	1245.25.55017 Boehringer Ingelheim Investigational Site	Marilia
Brazil	1245.25.55022 Boehringer Ingelheim Investigational Site	Maringá
Brazil	1245.25.55008 Boehringer Ingelheim Investigational Site	Porto Alegre
Brazil	1245.25.55016 Boehringer Ingelheim Investigational Site	Porto Alegre
Brazil	1245.25.55020 Boehringer Ingelheim Investigational Site	Porto Alegre
Brazil	1245.25.55012 Boehringer Ingelheim Investigational Site	Ribeirão Preto
Brazil	1245.25.55013 Boehringer Ingelheim Investigational Site	São José do Rio Preto
Brazil	1245.25.55004 Boehringer Ingelheim Investigational Site	São Paulo
Brazil	1245.25.55010 Boehringer Ingelheim Investigational Site	São Paulo
Brazil	1245.25.55018 Boehringer Ingelheim Investigational Site	São Paulo
Brazil	1245.25.55023 Boehringer Ingelheim Investigational Site	São Paulo
Brazil	1245.25.55006 Boehringer Ingelheim Investigational Site	Vila Albuquerque
Brazil	1245.25.55003 Boehringer Ingelheim Investigational Site	Vila Clementino
Brazil	1245.25.55005 Boehringer Ingelheim Investigational Site	Vila Leopoldina
Brazil	1245.25.55001 Boehringer Ingelheim Investigational Site	Villa Clementino
Canada	1245.25.20045 Boehringer Ingelheim Investigational Site	Brampton	Ontario
Canada	1245.25.20042 Boehringer Ingelheim Investigational Site	Burlington	Ontario
Canada	1245.25.20050 Boehringer Ingelheim Investigational Site	Gatineau	Quebec
Canada	1245.25.20026 Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia
Canada	1245.25.20043 Boehringer Ingelheim Investigational Site	Longueuil	Quebec
Canada	1245.25.20046 Boehringer Ingelheim Investigational Site	Longueuil	Quebec
Canada	1245.25.20009 Boehringer Ingelheim Investigational Site	Newmarket	Ontario
Canada	1245.25.20044 Boehringer Ingelheim Investigational Site	Niagara Falls	Ontario
Canada	1245.25.20013 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	1245.25.20041 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	1245.25.20049 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1245.25.20047 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1245.25.20048 Boehringer Ingelheim Investigational Site	Winnipeg	Manitoba
Colombia	1245.25.57010 Boehringer Ingelheim Investigational Site	Armenia
Colombia	1245.25.57004 Boehringer Ingelheim Investigational Site	Barranquilla
Colombia	1245.25.57001 Boehringer Ingelheim Investigational Site	Bogotá
Colombia	1245.25.57003 Boehringer Ingelheim Investigational Site	Bogotá
Colombia	1245.25.57011 Boehringer Ingelheim Investigational Site	Bogotá
Colombia	1245.25.57006 Boehringer Ingelheim Investigational Site	Floridablanca
Colombia	1245.25.57009 Boehringer Ingelheim Investigational Site	Medellín
Croatia	1245.25.71005 Boehringer Ingelheim Investigational Site	Karlovac
Croatia	1245.25.71001 Boehringer Ingelheim Investigational Site	Krapinske Toplice
Croatia	1245.25.71006 Boehringer Ingelheim Investigational Site	Osijek
Croatia	1245.25.71003 Boehringer Ingelheim Investigational Site	Rijeka
Croatia	1245.25.71002 Boehringer Ingelheim Investigational Site	Zagreb
Croatia	1245.25.71004 Boehringer Ingelheim Investigational Site	Zagreb
Czech Republic	1245.25.42020 Boehringer Ingelheim Investigational Site	Brno
Czech Republic	1245.25.42018 Boehringer Ingelheim Investigational Site	Jindrichuv Hradec
Czech Republic	1245.25.42015 Boehringer Ingelheim Investigational Site	Praha 3
Czech Republic	1245.25.42019 Boehringer Ingelheim Investigational Site	Usti nad Labem
Denmark	1245.25.45006 Boehringer Ingelheim Investigational Site	Frederiksberg
Denmark	1245.25.45003 Boehringer Ingelheim Investigational Site	Gentofte
Denmark	1245.25.45007 Boehringer Ingelheim Investigational Site	Helsingør
Denmark	1245.25.45002 Boehringer Ingelheim Investigational Site	København NV
Denmark	1245.25.45004 Boehringer Ingelheim Investigational Site	Randers NØ
Denmark	1245.25.45005 Boehringer Ingelheim Investigational Site	Slagelse
Estonia	1245.25.37002 Boehringer Ingelheim Investigational Site	Tallin
Estonia	1245.25.37005 Boehringer Ingelheim Investigational Site	Tallin
Estonia	1245.25.37003 Boehringer Ingelheim Investigational Site	Tallinn
Estonia	1245.25.37001 Boehringer Ingelheim Investigational Site	Tartu
Estonia	1245.25.37004 Boehringer Ingelheim Investigational Site	Tartu
France	1245.25.33022 Boehringer Ingelheim Investigational Site	Amiens
France	1245.25.33033 Boehringer Ingelheim Investigational Site	Angers
France	1245.25.33034 Boehringer Ingelheim Investigational Site	Angers
France	1245.25.33030 Boehringer Ingelheim Investigational Site	Bourg des cptes
France	1245.25.33023 Boehringer Ingelheim Investigational Site	Corbeil Essonnes
France	1245.25.33024 Boehringer Ingelheim Investigational Site	Derval
France	1245.25.33029 Boehringer Ingelheim Investigational Site	Equeurdreville Haineville
France	1245.25.33027 Boehringer Ingelheim Investigational Site	Fleury sur Orne
France	1245.25.33021 Boehringer Ingelheim Investigational Site	Grenoble
France	1245.25.33003 Boehringer Ingelheim Investigational Site	La Rochelle Cedex 1
France	1245.25.33032 Boehringer Ingelheim Investigational Site	Le Creusot
France	1245.25.33004 Boehringer Ingelheim Investigational Site	Narbonne Cedex
France	1245.25.33047 Boehringer Ingelheim Investigational Site	Pessac
France	1245.25.33046 Boehringer Ingelheim Investigational Site	Poitiers
France	1245.25.33025 Boehringer Ingelheim Investigational Site	Saint Priez en Jarez
France	1245.25.33035 Boehringer Ingelheim Investigational Site	Tours
Georgia	1245.25.99001 Boehringer Ingelheim Investigational Site	Batumi
Georgia	1245.25.99003 Boehringer Ingelheim Investigational Site	Kutaisi
Georgia	1245.25.99002 Boehringer Ingelheim Investigational Site	Tbilisi
Georgia	1245.25.99004 Boehringer Ingelheim Investigational Site	Tbilisi
Georgia	1245.25.99005 Boehringer Ingelheim Investigational Site	Tbilisi
Georgia	1245.25.99006 Boehringer Ingelheim Investigational Site	Tbilisi
Georgia	1245.25.99007 Boehringer Ingelheim Investigational Site	Tbilisi
Georgia	1245.25.99008 Boehringer Ingelheim Investigational Site	Tbilisi
Greece	1245.25.30002 Boehringer Ingelheim Investigational Site	Athens
Greece	1245.25.30003 Boehringer Ingelheim Investigational Site	Athens
Greece	1245.25.30004 Boehringer Ingelheim Investigational Site	Athens
Greece	1245.25.30007 Boehringer Ingelheim Investigational Site	Athens
Greece	1245.25.30005 Boehringer Ingelheim Investigational Site	Larissa
Greece	1245.25.30001 Boehringer Ingelheim Investigational Site	Nikaia
Greece	1245.25.30006 Boehringer Ingelheim Investigational Site	Thessaloniki
Greece	1245.25.30008 Boehringer Ingelheim Investigational Site	Thessaloniki
Hong Kong	1245.25.85201 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1245.25.85205 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1245.25.85207 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1245.25.85208 Boehringer Ingelheim Investigational Site	Hong Kong
Hungary	1245.25.36002 Boehringer Ingelheim Investigational Site	Budapest
Hungary	1245.25.36004 Boehringer Ingelheim Investigational Site	Budapest
Hungary	1245.25.36008 Boehringer Ingelheim Investigational Site	Budapest
Hungary	1245.25.36006 Boehringer Ingelheim Investigational Site	Dunaujvaros
Hungary	1245.25.36001 Boehringer Ingelheim Investigational Site	Gyula
Hungary	1245.25.36010 Boehringer Ingelheim Investigational Site	Kisvarda
Hungary	1245.25.36003 Boehringer Ingelheim Investigational Site	Szekszard
Hungary	1245.25.36011 Boehringer Ingelheim Investigational Site	Szikszo
India	1245.25.91307 Boehringer Ingelheim Investigational Site	Ahmedabad
India	1245.25.91302 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.25.91317 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.25.91319 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.25.91320 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.25.91303 Boehringer Ingelheim Investigational Site	Chennai
India	1245.25.91315 Boehringer Ingelheim Investigational Site	Cochin
India	1245.25.91311 Boehringer Ingelheim Investigational Site	Hyderabad
India	1245.25.91318 Boehringer Ingelheim Investigational Site	Indore
India	1245.25.91305 Boehringer Ingelheim Investigational Site	Jaipur
India	1245.25.91309 Boehringer Ingelheim Investigational Site	Jalandhar
India	1245.25.91313 Boehringer Ingelheim Investigational Site	Nagpur
India	1245.25.91324 Boehringer Ingelheim Investigational Site	Nagpur
India	1245.25.91301 Boehringer Ingelheim Investigational Site	Nashik, Maharashtra
India	1245.25.91308 Boehringer Ingelheim Investigational Site	Pune
India	1245.25.91316 Boehringer Ingelheim Investigational Site	Secunderabad
India	1245.25.91321 Boehringer Ingelheim Investigational Site	Varanasi
India	1245.25.91314 Boehringer Ingelheim Investigational Site	Vijaywada
Indonesia	1245.25.62006 Boehringer Ingelheim Investigational Site	Denpasar, Bali
Indonesia	1245.25.62009 Boehringer Ingelheim Investigational Site	Depok
Indonesia	1245.25.62002 Boehringer Ingelheim Investigational Site	Jakarta
Indonesia	1245.25.62008 Boehringer Ingelheim Investigational Site	Jakarta
Indonesia	1245.25.62010 Boehringer Ingelheim Investigational Site	Jakarta
Indonesia	1245.25.62004 Boehringer Ingelheim Investigational Site	Malang
Indonesia	1245.25.62003 Boehringer Ingelheim Investigational Site	Surabaya
Indonesia	1245.25.62001 Boehringer Ingelheim Investigational Site	Yogyakarta
Israel	1245.25.97003 Boehringer Ingelheim Investigational Site	Afula
Israel	1245.25.97006 Boehringer Ingelheim Investigational Site	Hadera
Israel	1245.25.97008 Boehringer Ingelheim Investigational Site	Haifa
Israel	1245.25.97009 Boehringer Ingelheim Investigational Site	Holon
Israel	1245.25.97005 Boehringer Ingelheim Investigational Site	Nahariya
Israel	1245.25.97001 Boehringer Ingelheim Investigational Site	Safed
Israel	1245.25.97002 Boehringer Ingelheim Investigational Site	Zerifin
Italy	1245.25.39007 Boehringer Ingelheim Investigational Site	Bologna
Italy	1245.25.39002 Boehringer Ingelheim Investigational Site	Campobasso
Italy	1245.25.39008 Boehringer Ingelheim Investigational Site	Catanzaro
Italy	1245.25.39010 Boehringer Ingelheim Investigational Site	Chieti
Italy	1245.25.39024 Boehringer Ingelheim Investigational Site	Ferrara
Italy	1245.25.39009 Boehringer Ingelheim Investigational Site	Firenze
Italy	1245.25.39005 Boehringer Ingelheim Investigational Site	Foggia
Italy	1245.25.39004 Boehringer Ingelheim Investigational Site	Napoli
Italy	1245.25.39006 Boehringer Ingelheim Investigational Site	Padova
Italy	1245.25.39001 Boehringer Ingelheim Investigational Site	Pisa
Italy	1245.25.39003 Boehringer Ingelheim Investigational Site	Roma
Italy	1245.25.39011 Boehringer Ingelheim Investigational Site	Roma
Italy	1245.25.39012 Boehringer Ingelheim Investigational Site	Roma
Italy	1245.25.39014 Boehringer Ingelheim Investigational Site	Roma
Italy	1245.25.39013 Boehringer Ingelheim Investigational Site	Venezia
Japan	1245.25.81008 Boehringer Ingelheim Investigational Site	Chuo-ku, tokyo
Japan	1245.25.81010 Boehringer Ingelheim Investigational Site	Gifushi, Gifu
Japan	1245.25.81002 Boehringer Ingelheim Investigational Site	Hanyushi, Saitama
Japan	1245.25.81013 Boehringer Ingelheim Investigational Site	Kamigyo-ku, Kyotoshi, Kyoto
Japan	1245.25.81003 Boehringer Ingelheim Investigational Site	Kishiwadashi. Osaka
Japan	1245.25.81012 Boehringer Ingelheim Investigational Site	Kita-ku, Nagoyashi, Aichi
Japan	1245.25.81014 Boehringer Ingelheim Investigational Site	Kumamoto-shi, Kumamoto
Japan	1245.25.81001 Boehringer Ingelheim Investigational Site	Matsudoshi, Chiba
Japan	1245.25.81006 Boehringer Ingelheim Investigational Site	Mitoshi, Ibaraki
Japan	1245.25.81005 Boehringer Ingelheim Investigational Site	Nishi-ku, Sapporoshi, Hokkaido
Japan	1245.25.81007 Boehringer Ingelheim Investigational Site	Nodashi, Chiba
Japan	1245.25.81004 Boehringer Ingelheim Investigational Site	Shimajiri-gun,Okinawa
Japan	1245.25.81009 Boehringer Ingelheim Investigational Site	Toyamashi, Toyama
Japan	1245.25.81015 Boehringer Ingelheim Investigational Site	Toyoakeshi, Aichi
Korea, Republic of	1245.25.82030 Boehringer Ingelheim Investigational Site	Busan
Korea, Republic of	1245.25.82018 Boehringer Ingelheim Investigational Site	Daegu
Korea, Republic of	1245.25.82021 Boehringer Ingelheim Investigational Site	Daejeon
Korea, Republic of	1245.25.82031 Boehringer Ingelheim Investigational Site	Daejoen
Korea, Republic of	1245.25.82027 Boehringer Ingelheim Investigational Site	Goyang
Korea, Republic of	1245.25.82022 Boehringer Ingelheim Investigational Site	Gwangju
Korea, Republic of	1245.25.82029 Boehringer Ingelheim Investigational Site	Incheon
Korea, Republic of	1245.25.82017 Boehringer Ingelheim Investigational Site	Pusan
Korea, Republic of	1245.25.82015 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.25.82016 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.25.82019 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.25.82020 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.25.82023 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.25.82024 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.25.82025 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.25.82026 Boehringer Ingelheim Investigational Site	Suwon
Korea, Republic of	1245.25.82028 Boehringer Ingelheim Investigational Site	Wonju
Malaysia	1245.25.60019 Boehringer Ingelheim Investigational Site	Johor Bahru
Malaysia	1245.25.60020 Boehringer Ingelheim Investigational Site	Kedah
Malaysia	1245.25.60013 Boehringer Ingelheim Investigational Site	Kelantan
Malaysia	1245.25.60015 Boehringer Ingelheim Investigational Site	Kota Kinabalu
Malaysia	1245.25.60012 Boehringer Ingelheim Investigational Site	Kuala Lumpur
Malaysia	1245.25.60017 Boehringer Ingelheim Investigational Site	Kuala Lumpur
Malaysia	1245.25.60004 Boehringer Ingelheim Investigational Site	Pahang
Malaysia	1245.25.60016 Boehringer Ingelheim Investigational Site	Selangor
Malaysia	1245.25.60021 Boehringer Ingelheim Investigational Site	Selangor
Malaysia	1245.25.60018 Boehringer Ingelheim Investigational Site	Selangor Darul Ehsan
Mexico	1245.25.52009 Boehringer Ingelheim Investigational Site	Colonia Americana
Mexico	1245.25.52007 Boehringer Ingelheim Investigational Site	Distrito Federal
Mexico	1245.25.52013 Boehringer Ingelheim Investigational Site	Ladron de Guevara
Mexico	1245.25.52010 Boehringer Ingelheim Investigational Site	Los Robles
Mexico	1245.25.52001 Boehringer Ingelheim Investigational Site	Monterrey
Mexico	1245.25.52011 Boehringer Ingelheim Investigational Site	Reforma Social
Mexico	1245.25.52012 Boehringer Ingelheim Investigational Site	San Lucas tepetlcalco
Netherlands	1245.25.31015 Boehringer Ingelheim Investigational Site	Amersfoort
Netherlands	1245.25.31013 Boehringer Ingelheim Investigational Site	Apeldoorn
Netherlands	1245.25.31036 Boehringer Ingelheim Investigational Site	Baarle - Nassau
Netherlands	1245.25.31032 Boehringer Ingelheim Investigational Site	Delft
Netherlands	1245.25.31026 Boehringer Ingelheim Investigational Site	Den Helder
Netherlands	1245.25.31012 Boehringer Ingelheim Investigational Site	Geleen
Netherlands	1245.25.31017 Boehringer Ingelheim Investigational Site	Hardenberg
Netherlands	1245.25.31035 Boehringer Ingelheim Investigational Site	Heerlen
Netherlands	1245.25.31011 Boehringer Ingelheim Investigational Site	Hoogeveen
Netherlands	1245.25.31029 Boehringer Ingelheim Investigational Site	Hoogezand
Netherlands	1245.25.31023 Boehringer Ingelheim Investigational Site	Hoogwoud
Netherlands	1245.25.31009 Boehringer Ingelheim Investigational Site	Maastricht
Netherlands	1245.25.31031 Boehringer Ingelheim Investigational Site	Meppel
Netherlands	1245.25.31024 Boehringer Ingelheim Investigational Site	Nijverdal
Netherlands	1245.25.31014 Boehringer Ingelheim Investigational Site	Rotterdam
Netherlands	1245.25.31033 Boehringer Ingelheim Investigational Site	Rotterdam
Netherlands	1245.25.31030 Boehringer Ingelheim Investigational Site	Schiedam
Netherlands	1245.25.31002 Boehringer Ingelheim Investigational Site	Utrecht
Netherlands	1245.25.31028 Boehringer Ingelheim Investigational Site	Wildervank
Netherlands	1245.25.31034 Boehringer Ingelheim Investigational Site	Zutphen
New Zealand	1245.25.64004 Boehringer Ingelheim Investigational Site	Christchurch
New Zealand	1245.25.64001 Boehringer Ingelheim Investigational Site	Grafton / Auckland
New Zealand	1245.25.64003 Boehringer Ingelheim Investigational Site	Wellington
Norway	1245.25.47002 Boehringer Ingelheim Investigational Site	Fornebu
Norway	1245.25.47004 Boehringer Ingelheim Investigational Site	Gjøvik
Norway	1245.25.47009 Boehringer Ingelheim Investigational Site	Kløfta
Norway	1245.25.47008 Boehringer Ingelheim Investigational Site	Kongsvinger
Norway	1245.25.47001 Boehringer Ingelheim Investigational Site	Oslo
Norway	1245.25.47006 Boehringer Ingelheim Investigational Site	Oslo
Norway	1245.25.47007 Boehringer Ingelheim Investigational Site	Trondheim
Norway	1245.25.47005 Boehringer Ingelheim Investigational Site	Tynset
Peru	1245.25.51001 Boehringer Ingelheim Investigational Site	Arequipa
Peru	1245.25.51008 Boehringer Ingelheim Investigational Site	Arequipa
Peru	1245.25.51002 Boehringer Ingelheim Investigational Site	Bellavista
Peru	1245.25.51004 Boehringer Ingelheim Investigational Site	El Agustino
Peru	1245.25.51006 Boehringer Ingelheim Investigational Site	Ica
Peru	1245.25.51003 Boehringer Ingelheim Investigational Site	Jesus Maria
Peru	1245.25.51007 Boehringer Ingelheim Investigational Site	Lima
Peru	1245.25.51009 Boehringer Ingelheim Investigational Site	Lima
Peru	1245.25.51010 Boehringer Ingelheim Investigational Site	Lima
Peru	1245.25.51011 Boehringer Ingelheim Investigational Site	Lima
Peru	1245.25.51005 Boehringer Ingelheim Investigational Site	Miraflores
Philippines	1245.25.63016 Boehringer Ingelheim Investigational Site	Cavite City
Philippines	1245.25.63002 Boehringer Ingelheim Investigational Site	Cebu
Philippines	1245.25.63003 Boehringer Ingelheim Investigational Site	Davao
Philippines	1245.25.63020 Boehringer Ingelheim Investigational Site	Jaro Iloilo City
Philippines	1245.25.63001 Boehringer Ingelheim Investigational Site	Manila
Philippines	1245.25.63004 Boehringer Ingelheim Investigational Site	Manila
Philippines	1245.25.63018 Boehringer Ingelheim Investigational Site	Manila
Philippines	1245.25.63009 Boehringer Ingelheim Investigational Site	Marikina City
Philippines	1245.25.63021 Boehringer Ingelheim Investigational Site	Marikina City
Philippines	1245.25.63019 Boehringer Ingelheim Investigational Site	Tarlac
Poland	1245.25.48013 Boehringer Ingelheim Investigational Site	Gdansk
Poland	1245.25.48004 Boehringer Ingelheim Investigational Site	Lodz
Poland	1245.25.48009 Boehringer Ingelheim Investigational Site	Lodz
Poland	1245.25.48010 Boehringer Ingelheim Investigational Site	Lodz
Poland	1245.25.48001 Boehringer Ingelheim Investigational Site	Lublin
Poland	1245.25.48014 Boehringer Ingelheim Investigational Site	Oswiecim
Poland	1245.25.48002 Boehringer Ingelheim Investigational Site	Poznan
Poland	1245.25.48008 Boehringer Ingelheim Investigational Site	Pulawy
Poland	1245.25.48007 Boehringer Ingelheim Investigational Site	Ruda Slaska
Poland	1245.25.48005 Boehringer Ingelheim Investigational Site	Torun
Poland	1245.25.48011 Boehringer Ingelheim Investigational Site	Torun
Portugal	1245.25.35006 Boehringer Ingelheim Investigational Site	Amadora
Portugal	1245.25.35004 Boehringer Ingelheim Investigational Site	Coimbra
Portugal	1245.25.35018 Boehringer Ingelheim Investigational Site	Faro
Portugal	1245.25.35021 Boehringer Ingelheim Investigational Site	Funchal
Portugal	1245.25.35008 Boehringer Ingelheim Investigational Site	Leiria
Portugal	1245.25.35001 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1245.25.35002 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1245.25.35015 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1245.25.35017 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1245.25.35011 Boehringer Ingelheim Investigational Site	Porto
Portugal	1245.25.35005 Boehringer Ingelheim Investigational Site	Santiago do Cacém
Portugal	1245.25.35020 Boehringer Ingelheim Investigational Site	Torres Novas
Portugal	1245.25.35014 Boehringer Ingelheim Investigational Site	Viana do Castelo
Portugal	1245.25.35019 Boehringer Ingelheim Investigational Site	Vila Nova de Gaia
Romania	1245.25.40008 Boehringer Ingelheim Investigational Site	Alba Iulia
Romania	1245.25.40011 Boehringer Ingelheim Investigational Site	Baia Mare Maramures
Romania	1245.25.40003 Boehringer Ingelheim Investigational Site	Bucharest
Romania	1245.25.40007 Boehringer Ingelheim Investigational Site	Bucharest
Romania	1245.25.40005 Boehringer Ingelheim Investigational Site	Constanta
Romania	1245.25.40002 Boehringer Ingelheim Investigational Site	Craiova
Romania	1245.25.40006 Boehringer Ingelheim Investigational Site	Craiova
Romania	1245.25.40009 Boehringer Ingelheim Investigational Site	Oradea
Romania	1245.25.40010 Boehringer Ingelheim Investigational Site	Targu-Mures
Russian Federation	1245.25.70019 Boehringer Ingelheim Investigational Site	Barnaul
Russian Federation	1245.25.70015 Boehringer Ingelheim Investigational Site	Kemerovo
Russian Federation	1245.25.70020 Boehringer Ingelheim Investigational Site	Kemerovo
Russian Federation	1245.25.70003 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.25.70009 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.25.70011 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.25.70016 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.25.70021 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.25.70022 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.25.70014 Boehringer Ingelheim Investigational Site	Novosibirsk
Russian Federation	1245.25.70018 Boehringer Ingelheim Investigational Site	Novosibirsk
Russian Federation	1245.25.70024 Boehringer Ingelheim Investigational Site	Novosibirsk
Russian Federation	1245.25.70028 Boehringer Ingelheim Investigational Site	Novosibirsk
Russian Federation	1245.25.70005 Boehringer Ingelheim Investigational Site	Saint Petersburg
Russian Federation	1245.25.70025 Boehringer Ingelheim Investigational Site	Saint Petersburg
Russian Federation	1245.25.70026 Boehringer Ingelheim Investigational Site	Saint Petersburg
Russian Federation	1245.25.70027 Boehringer Ingelheim Investigational Site	Saint Petersburg
Russian Federation	1245.25.70001 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1245.25.70004 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1245.25.70006 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1245.25.70013 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1245.25.70017 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1245.25.70023 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1245.25.70002 Boehringer Ingelheim Investigational Site	Vsevolozhsk
Russian Federation	1245.25.70029 Boehringer Ingelheim Investigational Site	Yaroslavl
Singapore	1245.25.65001 Boehringer Ingelheim Investigational Site	Singapore
Singapore	1245.25.65003 Boehringer Ingelheim Investigational Site	Singapore
Singapore	1245.25.65004 Boehringer Ingelheim Investigational Site	Singapore
South Africa	1245.25.76007 Boehringer Ingelheim Investigational Site	Alberton
South Africa	1245.25.76002 Boehringer Ingelheim Investigational Site	Bellville
South Africa	1245.25.76009 Boehringer Ingelheim Investigational Site	Bloemfontein
South Africa	1245.25.76014 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1245.25.76020 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1245.25.76022 Boehringer Ingelheim Investigational Site	Chatsworth Unit 10
South Africa	1245.25.76013 Boehringer Ingelheim Investigational Site	Durban
South Africa	1245.25.76016 Boehringer Ingelheim Investigational Site	Durban
South Africa	1245.25.76019 Boehringer Ingelheim Investigational Site	Durban
South Africa	1245.25.76003 Boehringer Ingelheim Investigational Site	Goodwood
South Africa	1245.25.76001 Boehringer Ingelheim Investigational Site	Houghton
South Africa	1245.25.76021 Boehringer Ingelheim Investigational Site	Kempton Park
South Africa	1245.25.76017 Boehringer Ingelheim Investigational Site	Krugersdorp
South Africa	1245.25.76004 Boehringer Ingelheim Investigational Site	Newtown
South Africa	1245.25.76006 Boehringer Ingelheim Investigational Site	Paarl
South Africa	1245.25.76005 Boehringer Ingelheim Investigational Site	Parow
South Africa	1245.25.76018 Boehringer Ingelheim Investigational Site	Port Elizabeth
South Africa	1245.25.76015 Boehringer Ingelheim Investigational Site	Somerset West
South Africa	1245.25.76012 Boehringer Ingelheim Investigational Site	Sydenham
South Africa	1245.25.76008 Boehringer Ingelheim Investigational Site	Tongaat
South Africa	1245.25.76023 Boehringer Ingelheim Investigational Site	Worcester
Spain	1245.25.34025 Boehringer Ingelheim Investigational Site	Alcorcon (Madrid)
Spain	1245.25.34048 Boehringer Ingelheim Investigational Site	Alicante
Spain	1245.25.34050 Boehringer Ingelheim Investigational Site	Alzira
Spain	1245.25.34039 Boehringer Ingelheim Investigational Site	Avila
Spain	1245.25.34040 Boehringer Ingelheim Investigational Site	Badía del Vallès - Barcelona
Spain	1245.25.34029 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1245.25.34030 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1245.25.34049 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1245.25.34031 Boehringer Ingelheim Investigational Site	Granada
Spain	1245.25.34024 Boehringer Ingelheim Investigational Site	Leganes (Madrid)
Spain	1245.25.34013 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.25.34023 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.25.34026 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.25.34028 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.25.34033 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.25.34036 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.25.34038 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.25.34022 Boehringer Ingelheim Investigational Site	Mahadahonda (Madrid)
Spain	1245.25.34047 Boehringer Ingelheim Investigational Site	Palma de Mallorca
Spain	1245.25.34034 Boehringer Ingelheim Investigational Site	Sabadell (Barcelona)
Spain	1245.25.34027 Boehringer Ingelheim Investigational Site	Salamanca
Spain	1245.25.34037 Boehringer Ingelheim Investigational Site	Santa Cruz de Tenerife
Spain	1245.25.34046 Boehringer Ingelheim Investigational Site	Segovia
Sri Lanka	1245.25.94002 Boehringer Ingelheim Investigational Site	Colombo
Sri Lanka	1245.25.94005 Boehringer Ingelheim Investigational Site	Kalubowila
Sri Lanka	1245.25.94004 Boehringer Ingelheim Investigational Site	Kandy
Sri Lanka	1245.25.94006 Boehringer Ingelheim Investigational Site	Kandy
Sri Lanka	1245.25.94001 Boehringer Ingelheim Investigational Site	Nugegoda
Sri Lanka	1245.25.94003 Boehringer Ingelheim Investigational Site	Ragama
Taiwan	1245.25.88022 Boehringer Ingelheim Investigational Site	Hualien
Taiwan	1245.25.88010 Boehringer Ingelheim Investigational Site	Kaohsiung
Taiwan	1245.25.88019 Boehringer Ingelheim Investigational Site	Kaohsiung
Taiwan	1245.25.88009 Boehringer Ingelheim Investigational Site	Taichung
Taiwan	1245.25.88020 Boehringer Ingelheim Investigational Site	Taichung
Taiwan	1245.25.88018 Boehringer Ingelheim Investigational Site	Tainan
Taiwan	1245.25.88015 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1245.25.88016 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1245.25.88023 Boehringer Ingelheim Investigational Site	Tamsui, Taipei county
Taiwan	1245.25.88017 Boehringer Ingelheim Investigational Site	Taoyuan
Thailand	1245.25.66006 Boehringer Ingelheim Investigational Site	Bangkok
Thailand	1245.25.66007 Boehringer Ingelheim Investigational Site	Bangkok
Thailand	1245.25.66009 Boehringer Ingelheim Investigational Site	Chiang Mai
Thailand	1245.25.66004 Boehringer Ingelheim Investigational Site	Muang District
Thailand	1245.25.66010 Boehringer Ingelheim Investigational Site	Nakhonratchasima
Thailand	1245.25.66011 Boehringer Ingelheim Investigational Site	Pathum Tani
Ukraine	1245.25.75009 Boehringer Ingelheim Investigational Site	Kharkiv
Ukraine	1245.25.75011 Boehringer Ingelheim Investigational Site	Kharkiv
Ukraine	1245.25.75001 Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	1245.25.75008 Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	1245.25.75007 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1245.25.75012 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1245.25.75010 Boehringer Ingelheim Investigational Site	Odessa
United Kingdom	1245.25.44045 Boehringer Ingelheim Investigational Site	Airdrie
United Kingdom	1245.25.44020 Boehringer Ingelheim Investigational Site	Ashford
United Kingdom	1245.25.44013 Boehringer Ingelheim Investigational Site	Blackpool
United Kingdom	1245.25.44014 Boehringer Ingelheim Investigational Site	Bolton
United Kingdom	1245.25.44021 Boehringer Ingelheim Investigational Site	Bradford on Avon
United Kingdom	1245.25.44002 Boehringer Ingelheim Investigational Site	Dumfries
United Kingdom	1245.25.44009 Boehringer Ingelheim Investigational Site	Dundee
United Kingdom	1245.25.44005 Boehringer Ingelheim Investigational Site	Edinburgh
United Kingdom	1245.25.44004 Boehringer Ingelheim Investigational Site	Fowey
United Kingdom	1245.25.44001 Boehringer Ingelheim Investigational Site	Frome
United Kingdom	1245.25.44003 Boehringer Ingelheim Investigational Site	Inverness
United Kingdom	1245.25.44044 Boehringer Ingelheim Investigational Site	Wishaw
United States	1245.25.10145 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	1245.25.10180 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	1245.25.10035 Boehringer Ingelheim Investigational Site	Anaheim	California
United States	1245.25.10070 Boehringer Ingelheim Investigational Site	Anderson	South Carolina
United States	1245.25.10023 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	1245.25.10012 Boehringer Ingelheim Investigational Site	Auburn	Maine
United States	1245.25.10041 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	1245.25.10131 Boehringer Ingelheim Investigational Site	Binghamton	New York
United States	1245.25.10043 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	1245.25.10121 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	1245.25.10092 Boehringer Ingelheim Investigational Site	Boise	Idaho
United States	1245.25.10185 Boehringer Ingelheim Investigational Site	Bountiful	Utah
United States	1245.25.10094 Boehringer Ingelheim Investigational Site	Bradenton	Florida
United States	1245.25.10054 Boehringer Ingelheim Investigational Site	Bristol	Tennessee
United States	1245.25.10190 Boehringer Ingelheim Investigational Site	Brooksville	Florida
United States	1245.25.10218 Boehringer Ingelheim Investigational Site	Burke	Virginia
United States	1245.25.10196 Boehringer Ingelheim Investigational Site	Burlington	North Carolina
United States	1245.25.10207 Boehringer Ingelheim Investigational Site	Calabash	North Carolina
United States	1245.25.10044 Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	1245.25.10187 Boehringer Ingelheim Investigational Site	Charleston	West Virginia
United States	1245.25.10036 Boehringer Ingelheim Investigational Site	Chattanooga	Tennessee
United States	1245.25.10057 Boehringer Ingelheim Investigational Site	Chattanooga	Tennessee
United States	1245.25.10011 Boehringer Ingelheim Investigational Site	Chesterfield	Missouri
United States	1245.25.10097 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	1245.25.10060 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	1245.25.10086 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	1245.25.10154 Boehringer Ingelheim Investigational Site	Clairton	Pennsylvania
United States	1245.25.10173 Boehringer Ingelheim Investigational Site	Clairton	Pennsylvania
United States	1245.25.10209 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	1245.25.10144 Boehringer Ingelheim Investigational Site	Colorado Springs	Colorado
United States	1245.25.10174 Boehringer Ingelheim Investigational Site	Columbus	Georgia
United States	1245.25.10212 Boehringer Ingelheim Investigational Site	Cooper City	Florida
United States	1245.25.10075 Boehringer Ingelheim Investigational Site	Corpus Christi	Texas
United States	1245.25.10007 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1245.25.10026 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1245.25.10100 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1245.25.10165 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1245.25.10137 Boehringer Ingelheim Investigational Site	Dayton	Ohio
United States	1245.25.10071 Boehringer Ingelheim Investigational Site	Dearborn	Michigan
United States	1245.25.10138 Boehringer Ingelheim Investigational Site	Delaware	Ohio
United States	1245.25.10200 Boehringer Ingelheim Investigational Site	Delray Beach	Florida
United States	1245.25.10085 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	1245.25.10153 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	1245.25.10155 Boehringer Ingelheim Investigational Site	Draper	Utah
United States	1245.25.10053 Boehringer Ingelheim Investigational Site	Durham	North Carolina
United States	1245.25.10030 Boehringer Ingelheim Investigational Site	Eagan	Minnesota
United States	1245.25.10103 Boehringer Ingelheim Investigational Site	Encino	California
United States	1245.25.10082 Boehringer Ingelheim Investigational Site	Eugene	Oregon
United States	1245.25.10116 Boehringer Ingelheim Investigational Site	Evansville	Indiana
United States	1245.25.10052 Boehringer Ingelheim Investigational Site	Feasterville Trevose	Pennsylvania
United States	1245.25.10069 Boehringer Ingelheim Investigational Site	Fleetwood	Pennsylvania
United States	1245.25.10014 Boehringer Ingelheim Investigational Site	Flemington	New Jersey
United States	1245.25.10013 Boehringer Ingelheim Investigational Site	Flint	Michigan
United States	1245.25.10169 Boehringer Ingelheim Investigational Site	Fort Worth	Texas
United States	1245.25.10158 Boehringer Ingelheim Investigational Site	Fresno	California
United States	1245.25.10033 Boehringer Ingelheim Investigational Site	Ft. Lauderdale	Florida
United States	1245.25.10056 Boehringer Ingelheim Investigational Site	Gilbert	Arizona
United States	1245.25.10148 Boehringer Ingelheim Investigational Site	Great Falls	Montana
United States	1245.25.10191 Boehringer Ingelheim Investigational Site	Great Falls	Montana
United States	1245.25.10172 Boehringer Ingelheim Investigational Site	Greensburg	Pennsylvania
United States	1245.25.10010 Boehringer Ingelheim Investigational Site	Greenville	North Carolina
United States	1245.25.10002 Boehringer Ingelheim Investigational Site	Greer	South Carolina
United States	1245.25.10202 Boehringer Ingelheim Investigational Site	Hallandale Beach	Florida
United States	1245.25.10126 Boehringer Ingelheim Investigational Site	Harbor City	California
United States	1245.25.10048 Boehringer Ingelheim Investigational Site	Harrisburg	Arkansas
United States	1245.25.10062 Boehringer Ingelheim Investigational Site	Hialeah	Florida
United States	1245.25.10063 Boehringer Ingelheim Investigational Site	Hialeah	Florida
United States	1245.25.10157 Boehringer Ingelheim Investigational Site	Hialeah	Florida
United States	1245.25.10132 Boehringer Ingelheim Investigational Site	Hodges	South Carolina
United States	1245.25.10022 Boehringer Ingelheim Investigational Site	Honolulu	Hawaii
United States	1245.25.10003 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1245.25.10125 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1245.25.10189 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1245.25.10058 Boehringer Ingelheim Investigational Site	Huntington Park	California
United States	1245.25.10037 Boehringer Ingelheim Investigational Site	Huntsville	Alabama
United States	1245.25.10134 Boehringer Ingelheim Investigational Site	Hyattsville	Maryland
United States	1245.25.10050 Boehringer Ingelheim Investigational Site	Indiana	Pennsylvania
United States	1245.25.10089 Boehringer Ingelheim Investigational Site	Jacksonville	Florida
United States	1245.25.10163 Boehringer Ingelheim Investigational Site	Kansas City	Missouri
United States	1245.25.10156 Boehringer Ingelheim Investigational Site	Kettering	Ohio
United States	1245.25.10046 Boehringer Ingelheim Investigational Site	Kingsport	Tennessee
United States	1245.25.10001 Boehringer Ingelheim Investigational Site	Lancaster	California
United States	1245.25.10009 Boehringer Ingelheim Investigational Site	Lansdale	Pennsylvania
United States	1245.25.10186 Boehringer Ingelheim Investigational Site	Lexington	Kentucky
United States	1245.25.10015 Boehringer Ingelheim Investigational Site	Little Rock	Alaska
United States	1245.25.10019 Boehringer Ingelheim Investigational Site	Longwood	Florida
United States	1245.25.10102 Boehringer Ingelheim Investigational Site	Los Angeles	California
United States	1245.25.10047 Boehringer Ingelheim Investigational Site	Los Gatos	California
United States	1245.25.10109 Boehringer Ingelheim Investigational Site	Louisville	Kentucky
United States	1245.25.10119 Boehringer Ingelheim Investigational Site	Lubbock	Texas
United States	1245.25.10098 Boehringer Ingelheim Investigational Site	Madison	Wisconsin
United States	1245.25.10006 Boehringer Ingelheim Investigational Site	Madisonville	Kentucky
United States	1245.25.10168 Boehringer Ingelheim Investigational Site	Maitland	Florida
United States	1245.25.10091 Boehringer Ingelheim Investigational Site	Marion	Ohio
United States	1245.25.10143 Boehringer Ingelheim Investigational Site	Memphis	Tennessee
United States	1245.25.10018 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	1245.25.10039 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	1245.25.10184 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	1245.25.10079 Boehringer Ingelheim Investigational Site	Midvale	Utah
United States	1245.25.10028 Boehringer Ingelheim Investigational Site	Minneapolis	Minnesota
United States	1245.25.10124 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	1245.25.10182 Boehringer Ingelheim Investigational Site	Morgantown	West Virginia
United States	1245.25.10140 Boehringer Ingelheim Investigational Site	Mt. Pleasant	South Carolina
United States	1245.25.10065 Boehringer Ingelheim Investigational Site	Myrtle Beach	South Carolina
United States	1245.25.10127 Boehringer Ingelheim Investigational Site	Myrtle Beach	South Carolina
United States	1245.25.10078 Boehringer Ingelheim Investigational Site	New Braunfels	Texas
United States	1245.25.10020 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana
United States	1245.25.10004 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	1245.25.10114 Boehringer Ingelheim Investigational Site	Norman	Oklahoma
United States	1245.25.10170 Boehringer Ingelheim Investigational Site	North Myrtle Beach	South Carolina
United States	1245.25.10066 Boehringer Ingelheim Investigational Site	Norwalk	Connecticut
United States	1245.25.10076 Boehringer Ingelheim Investigational Site	Odessa	Texas
United States	1245.25.10034 Boehringer Ingelheim Investigational Site	Omaha	Nebraska
United States	1245.25.10123 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	1245.25.10201 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	1245.25.10005 Boehringer Ingelheim Investigational Site	Paducah	Kentucky
United States	1245.25.10118 Boehringer Ingelheim Investigational Site	Palm Springs	California
United States	1245.25.10133 Boehringer Ingelheim Investigational Site	Pearland	Texas
United States	1245.25.10025 Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	1245.25.10042 Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	1245.25.10175 Boehringer Ingelheim Investigational Site	Peoria	Arizona
United States	1245.25.10107 Boehringer Ingelheim Investigational Site	Petoskey	Michigan
United States	1245.25.10214 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	1245.25.10072 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	1245.25.10176 Boehringer Ingelheim Investigational Site	Picayune	Mississippi
United States	1245.25.10149 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	1245.25.10197 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	1245.25.10160 Boehringer Ingelheim Investigational Site	Plano	Texas
United States	1245.25.10147 Boehringer Ingelheim Investigational Site	Port Charlotte	Florida
United States	1245.25.10177 Boehringer Ingelheim Investigational Site	Richardson	Texas
United States	1245.25.10141 Boehringer Ingelheim Investigational Site	Riverdale	Georgia
United States	1245.25.10061 Boehringer Ingelheim Investigational Site	Riverside	California
United States	1245.25.10029 Boehringer Ingelheim Investigational Site	Rochester	New York
United States	1245.25.10067 Boehringer Ingelheim Investigational Site	Roswell	Georgia
United States	1245.25.10198 Boehringer Ingelheim Investigational Site	Saint Petersburg	Florida
United States	1245.25.10203 Boehringer Ingelheim Investigational Site	Saint Petersburg	Florida
United States	1245.25.10080 Boehringer Ingelheim Investigational Site	Salt Lake City	Utah
United States	1245.25.10049 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	1245.25.10161 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	1245.25.10040 Boehringer Ingelheim Investigational Site	San Diego	California
United States	1245.25.10055 Boehringer Ingelheim Investigational Site	San Diego	California
United States	1245.25.10193 Boehringer Ingelheim Investigational Site	San Diego	California
United States	1245.25.10027 Boehringer Ingelheim Investigational Site	Santa Rosa	California
United States	1245.25.10159 Boehringer Ingelheim Investigational Site	Scottdale	Pennsylvania
United States	1245.25.10142 Boehringer Ingelheim Investigational Site	Smithtown	New York
United States	1245.25.10111 Boehringer Ingelheim Investigational Site	South Chesterfield	Virginia
United States	1245.25.10087 Boehringer Ingelheim Investigational Site	South Ogden	Utah
United States	1245.25.10129 Boehringer Ingelheim Investigational Site	Spartanburg	South Carolina
United States	1245.25.10115 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	1245.25.10216 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	1245.25.10064 Boehringer Ingelheim Investigational Site	Springfield	Massachusetts
United States	1245.25.10096 Boehringer Ingelheim Investigational Site	Staten Island	New York
United States	1245.25.10074 Boehringer Ingelheim Investigational Site	Stockton	California
United States	1245.25.10017 Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	1245.25.10104 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	1245.25.10178 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	1245.25.10211 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	1245.25.10162 Boehringer Ingelheim Investigational Site	Tipton	Pennsylvania
United States	1245.25.10210 Boehringer Ingelheim Investigational Site	Towson	Maryland
United States	1245.25.10171 Boehringer Ingelheim Investigational Site	Union	South Carolina
United States	1245.25.10146 Boehringer Ingelheim Investigational Site	Uniontown	Pennsylvania
United States	1245.25.10083 Boehringer Ingelheim Investigational Site	Valencia	California
United States	1245.25.10206 Boehringer Ingelheim Investigational Site	Valparaiso	Indiana
United States	1245.25.10016 Boehringer Ingelheim Investigational Site	Walla Walla	Washington
United States	1245.25.10068 Boehringer Ingelheim Investigational Site	Washington	District of Columbia
United States	1245.25.10038 Boehringer Ingelheim Investigational Site	Waterbury	Connecticut
United States	1245.25.10051 Boehringer Ingelheim Investigational Site	Watertown	Massachusetts
United States	1245.25.10021 Boehringer Ingelheim Investigational Site	Wichita	Kansas
United States	1245.25.10077 Boehringer Ingelheim Investigational Site	Yardley	Pennsylvania
United States	1245.25.10192 Boehringer Ingelheim Investigational Site	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  Croatia,  Czech Republic,  Denmark,  Estonia,  France,  Georgia,  Greece,  Hong Kong,  Hungary,  India,  Indonesia,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  South Africa,  Spain,  Sri Lanka,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint: cardiovascular death (including fatal stroke and fatal myocardial infarction(MI)), non-fatal MI (excluding silent MI) and non-fatal stroke.		up to 5 years	No
Secondary	The composite of all events adjudicated: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction, non-fatal stroke (excluding silent MI) and hospitalization for unstable angina pectoris.		up to 5 years	No
Secondary	To determine the incidence of new onset albuminuria		up to 5 years	No
Secondary	To determine the incidence of silent MI		up to 5 years	No
Secondary	To determine the incidence of heart failure requiring hospitalization		up to 5 years	No
Secondary	To determine the incidence of new onset macroalbuminuria		up to 5 years	No
Secondary	Composite microvascular outcome		up to 5 years	No