Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Glimepiride
Drug: BI 10773
Drug: Placebo

Registration Number: NCT01167881

Lead Sponsor: Boehringer Ingelheim

Brief Summary: This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1549

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glimepiride 1-4 mg plus metformin	Glimepiride	Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.
BI 10773 dose plus metformin	Placebo	Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
BI 10773 dose plus metformin	BI 10773	Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
Glimepiride 1-4 mg plus metformin	Placebo	Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.

Primary Outcome Measures

Name	Time	Method
The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.	Baseline and 104 weeks

Secondary Outcome Measures

Name	Time	Method
The Change From Baseline in HbA1c After 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Body Weight From Baseline After 104 Weeks of Treatment.	baseline and 104 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.	baseline and 104 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.	baseline and 104 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.	baseline and 104 weeks
The Change in Body Weight From Baseline After 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.	baseline and 52 weeks

Trial Locations

Locations (182): 1245.28.43003 Boehringer Ingelheim Investigational Site
🇦🇹
Wien, Austria
1245.28.10030 Boehringer Ingelheim Investigational Site
🇺🇸
Draper, Utah, United States
1245.28.10014 Boehringer Ingelheim Investigational Site
🇺🇸
Rochester, New York, United States
1245.28.10009 Boehringer Ingelheim Investigational Site
🇺🇸
Bradednton, Florida, United States
1245.28.10021 Boehringer Ingelheim Investigational Site
🇺🇸
West Hills, California, United States
1245.28.54001 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
1245.28.10003 Boehringer Ingelheim Investigational Site
🇺🇸
Sacramento, California, United States
1245.28.20080 Boehringer Ingelheim Investigational Site
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Collingwood, Ontario, Canada
1245.28.20074 Boehringer Ingelheim Investigational Site
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Calgary, Alberta, Canada
1245.28.41017 Inselspital Bern
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Bern, Switzerland
1245.28.20084 Boehringer Ingelheim Investigational Site
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Langley, British Columbia, Canada
1245.28.20076 Boehringer Ingelheim Investigational Site
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Quebec, Canada
1245.28.91210 Boehringer Ingelheim Investigational Site
🇮🇳
Mangalore, India
1245.28.47001 Boehringer Ingelheim Investigational Site
🇳🇴
Oslo, Norway
1245.28.76012 Boehringer Ingelheim Investigational Site
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Durban, South Africa
1245.28.46008 Boehringer Ingelheim Investigational Site
🇸🇪
Lund, Sweden
1245.28.34004 Boehringer Ingelheim Investigational Site
🇪🇸
Barcelona, Spain
1245.28.76016 Boehringer Ingelheim Investigational Site
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Cape Town, South Africa
1245.28.76017 Boehringer Ingelheim Investigational Site
🇿🇦
Cape Town, South Africa
1245.28.63020 Boehringer Ingelheim Investigational Site
🇵🇭
Jaro Iloilo City, Philippines
1245.28.34010 Boehringer Ingelheim Investigational Site
🇪🇸
San Sebastian de los Reyes, Spain
1245.28.34009 Boehringer Ingelheim Investigational Site
🇪🇸
Granada, Spain
1245.28.63016 Boehringer Ingelheim Investigational Site
🇵🇭
Cavite City, Philippines
1245.28.46009 Boehringer Ingelheim Investigational Site
🇸🇪
Borås, Sweden
1245.28.46006 Boehringer Ingelheim Investigational Site
🇸🇪
Stockholm, Sweden
1245.28.34011 Boehringer Ingelheim Investigational Site
🇪🇸
Barcelona, Spain
1245.28.76019 Boehringer Ingelheim Investigational Site
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Boksburg North, South Africa
1245.28.76018 Boehringer Ingelheim Investigational Site
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Bryanston, South Africa
1245.28.76024 Boehringer Ingelheim Investigational Site
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Lenasia, South Africa
1245.28.34013 Boehringer Ingelheim Investigational Site
🇪🇸
Madrid, Spain
1245.28.34002 Boehringer Ingelheim Investigational Site
🇪🇸
Burjasot, Spain
1245.28.76013 Boehringer Ingelheim Investigational Site
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Krugersdorp, South Africa
1245.28.76023 Boehringer Ingelheim Investigational Site
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Lenasia South, South Africa
1245.28.34001 Boehringer Ingelheim Investigational Site
🇪🇸
Pineda de Mar, Spain
1245.28.34012 Boehringer Ingelheim Investigational Site
🇪🇸
Madrid, Spain
1245.28.76014 Boehringer Ingelheim Investigational Site
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Pretoria, South Africa
1245.28.46002 Boehringer Ingelheim Investigational Site
🇸🇪
Stockholm, Sweden
1245.28.44008 Boehringer Ingelheim Investigational Site
🇬🇧
Balham, United Kingdom
1245.28.76015 Boehringer Ingelheim Investigational Site
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Durban, South Africa
1245.28.34005 Boehringer Ingelheim Investigational Site
🇪🇸
Mataró, Spain
1245.28.44020 Boehringer Ingelheim Investigational Site
🇬🇧
Ashford, United Kingdom
1245.28.44035 Boehringer Ingelheim Investigational Site
🇬🇧
Barnstable, United Kingdom
1245.28.44022 Boehringer Ingelheim Investigational Site
🇬🇧
Chippenham, United Kingdom
1245.28.10033 Boehringer Ingelheim Investigational Site
🇺🇸
Blue Ridge, Georgia, United States
1245.28.10013 Boehringer Ingelheim Investigational Site
🇺🇸
Kenosha, Wisconsin, United States
1245.28.54002 Boehringer Ingelheim Investigational Site
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Córdoba, Argentina
1245.28.20082 Boehringer Ingelheim Investigational Site
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Grand Falls-Windsor, Newfoundland and Labrador, Canada
1245.28.20078 Boehringer Ingelheim Investigational Site
🇨🇦
Stayner, Ontario, Canada
1245.28.20072 Boehringer Ingelheim Investigational Site
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Chicoutimi, Quebec, Canada
1245.28.57005 Boehringer Ingelheim Investigational Site
🇨🇴
Bogota, Colombia
1245.28.42001 Boehringer Ingelheim Investigational Site
🇨🇿
Slany, Czech Republic
1245.28.91211 Boehringer Ingelheim Investigational Site
🇮🇳
Kolkata, India
1245.28.52008 Boehringer Ingelheim Investigational Site
🇲🇽
Cuautla, Mexico
1245.28.52007 Boehringer Ingelheim Investigational Site
🇲🇽
Mexico, Mexico
1245.28.35012 Boehringer Ingelheim Investigational Site
🇵🇹
Porto, Portugal
1245.28.34003 Boehringer Ingelheim Investigational Site
🇪🇸
Centelles, Spain
1245.28.46007 Boehringer Ingelheim Investigational Site
🇸🇪
Stockholm, Sweden
1245.28.44021 Boehringer Ingelheim Investigational Site
🇬🇧
Bradford on Avon, United Kingdom
1245.28.44007 Boehringer Ingelheim Investigational Site
🇬🇧
Midsomer Norton, United Kingdom
1245.28.10011 Boehringer Ingelheim Investigational Site
🇺🇸
Cincinnati, Ohio, United States
1245.28.10019 Boehringer Ingelheim Investigational Site
🇺🇸
Cincinnati, Ohio, United States
1245.28.10023 Boehringer Ingelheim Investigational Site
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Salt Lake City, Utah, United States
1245.28.10005 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
1245.28.10026 Boehringer Ingelheim Investigational Site
🇺🇸
Boise, Idaho, United States
1245.28.20073 Boehringer Ingelheim Investigational Site
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Sherbrooke, Quebec, Canada
1245.28.54003 Boehringer Ingelheim Investigational Site
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Córdoba, Argentina
1245.28.20070 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Canada
1245.28.20077 Boehringer Ingelheim Investigational Site
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Calgary, Alberta, Canada
1245.28.20016 Boehringer Ingelheim Investigational Site
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Mount Pearl, Newfoundland and Labrador, Canada
1245.28.43006 Boehringer Ingelheim Investigational Site
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Graz, Austria
1245.28.43004 Boehringer Ingelheim Investigational Site
🇦🇹
Wien, Austria
1245.28.57003 Boehringer Ingelheim Investigational Site
🇨🇴
Bogotá, Colombia
1245.28.42006 Boehringer Ingelheim Investigational Site
🇨🇿
Zlin, Czech Republic
1245.28.72002 Boehringer Ingelheim Investigational Site
🇫🇮
Pori, Finland
1245.28.91204 Boehringer Ingelheim Investigational Site
🇮🇳
Bangalore, India
1245.28.20071 Boehringer Ingelheim Investigational Site
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Halifax, Nova Scotia, Canada
1245.28.10016 Boehringer Ingelheim Investigational Site
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Hot Springs, Arkansas, United States
1245.28.20079 Boehringer Ingelheim Investigational Site
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St. John's, Newfoundland and Labrador, Canada
1245.28.10027 Boehringer Ingelheim Investigational Site
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Henderson, Nevada, United States
1245.28.20043 Boehringer Ingelheim Investigational Site
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Longueuil, Quebec, Canada
1245.28.54010 Boehringer Ingelheim Investigational Site
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Buenos Aires, Argentina
1245.28.72004 Boehringer Ingelheim Investigational Site
🇫🇮
Joensuu, Finland
1245.28.91205 Boehringer Ingelheim Investigational Site
🇮🇳
Bangalore, India
1245.28.91208 Boehringer Ingelheim Investigational Site
🇮🇳
Bangalore, India
1245.28.91201 Boehringer Ingelheim Investigational Site
🇮🇳
Chennai, India
1245.28.91203 Boehringer Ingelheim Investigational Site
🇮🇳
Hyderabad, India
1245.28.91207 Boehringer Ingelheim Investigational Site
🇮🇳
Pune, India
1245.28.60006 Boehringer Ingelheim Investigational Site
🇲🇾
Kelantan, Malaysia
1245.28.60010 Boehringer Ingelheim Investigational Site
🇲🇾
Pulau Pinang, Malaysia
1245.28.20085 Boehringer Ingelheim Investigational Site
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Gatineau, Quebec, Canada
1245.28.20021 Boehringer Ingelheim Investigational Site
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Trois Rivieres, Quebec, Canada
1245.28.10012 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
1245.28.57007 Boehringer Ingelheim Investigational Site
🇨🇴
Barranquilla, Colombia
1245.28.57006 Boehringer Ingelheim Investigational Site
🇨🇴
Floridablanca, Colombia
1245.28.42005 Boehringer Ingelheim Investigational Site
🇨🇿
Holice, Czech Republic
1245.28.42002 Boehringer Ingelheim Investigational Site
🇨🇿
Mlada Boleslav, Czech Republic
1245.28.72001 Boehringer Ingelheim Investigational Site
🇫🇮
Helsinki, Finland
1245.28.91206 Boehringer Ingelheim Investigational Site
🇮🇳
Ahmedabad, India
1245.28.91202 Boehringer Ingelheim Investigational Site
🇮🇳
Bangalore, India
1245.28.91212 Boehringer Ingelheim Investigational Site
🇮🇳
New Delhi, India
1245.28.91209 Boehringer Ingelheim Investigational Site
🇮🇳
Uttar Pradesh, India
1245.28.60003 Boehringer Ingelheim Investigational Site
🇲🇾
Johor Bahru, Malaysia
1245.28.60005 Boehringer Ingelheim Investigational Site
🇲🇾
Kuala Lumpur, Malaysia
1245.28.31008 Boehringer Ingelheim Investigational Site
🇳🇱
's HERTOGENBOSCH, Netherlands
1245.28.63011 Boehringer Ingelheim Investigational Site
🇵🇭
Quezon City, Philippines
1245.28.43005 Boehringer Ingelheim Investigational Site
🇦🇹
Salzburg, Austria
1245.28.43001 Boehringer Ingelheim Investigational Site
🇦🇹
Wien, Austria
1245.28.43002 Boehringer Ingelheim Investigational Site
🇦🇹
Wien, Austria
1245.28.20081 Boehringer Ingelheim Investigational Site
🇨🇦
Chicoutimi, Quebec, Canada
1245.28.42008 Boehringer Ingelheim Investigational Site
🇨🇿
Praha 1, Czech Republic
1245.28.42007 Boehringer Ingelheim Investigational Site
🇨🇿
Slany, Czech Republic
1245.28.72003 Boehringer Ingelheim Investigational Site
🇫🇮
Oulu, Finland
1245.28.63012 Boehringer Ingelheim Investigational Site
🇵🇭
Pasig City, Philippines
1245.28.35002 Boehringer Ingelheim Investigational Site
🇵🇹
Lisboa, Portugal
1245.28.42003 Boehringer Ingelheim Investigational Site
🇨🇿
Brno, Czech Republic
1245.28.42004 Boehringer Ingelheim Investigational Site
🇨🇿
Uherske Hradiste, Czech Republic
1245.28.91213 Boehringer Ingelheim Investigational Site
🇮🇳
Chennai, India
1245.28.60009 Boehringer Ingelheim Investigational Site
🇲🇾
Kuala Lumpur, Malaysia
1245.28.60007 Boehringer Ingelheim Investigational Site
🇲🇾
Perak, Malaysia
1245.28.31020 Boehringer Ingelheim Investigational Site
🇳🇱
Losser, Netherlands
1245.28.47003 Boehringer Ingelheim Investigational Site
🇳🇴
Sandefjord, Norway
1245.28.63015 Boehringer Ingelheim Investigational Site
🇵🇭
Manila, Philippines
1245.28.63010 Boehringer Ingelheim Investigational Site
🇵🇭
Tacloban, Philippines
1245.28.35016 Boehringer Ingelheim Investigational Site
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Vila Nova de Gaia, Portugal
1245.28.41015 Boehringer Ingelheim Investigational Site
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Ascona, Switzerland
1245.28.66006 Boehringer Ingelheim Investigational Site
🇹🇭
Bangkok, Thailand
1245.28.60004 Boehringer Ingelheim Investigational Site
🇲🇾
Pahang, Malaysia
1245.28.60001 Boehringer Ingelheim Investigational Site
🇲🇾
Selangor Darul Ehsan, Malaysia
1245.28.52006 Boehringer Ingelheim Investigational Site
🇲🇽
Aguascalientes, Mexico
1245.28.52009 Boehringer Ingelheim Investigational Site
🇲🇽
Guadalajara, Mexico
1245.28.31014 Boehringer Ingelheim Investigational Site
🇳🇱
Rotterdam, Netherlands
1245.28.63013 Boehringer Ingelheim Investigational Site
🇵🇭
Cebu City, Philippines
1245.28.63014 Boehringer Ingelheim Investigational Site
🇵🇭
Tagbilaran City, Bohol, Philippines
1245.28.88002 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei Hsien, Taiwan
1245.28.66008 Boehringer Ingelheim Investigational Site
🇹🇭
Nakhonratchasima, Thailand
1245.28.47002 Boehringer Ingelheim Investigational Site
🇳🇴
Hønefoss, Norway
1245.28.63004 Boehringer Ingelheim Investigational Site
🇵🇭
Manila, Philippines
1245.28.88005 Boehringer Ingelheim Investigational Site
🇨🇳
Tainan Hsien, Taiwan
1245.28.66004 Boehringer Ingelheim Investigational Site
🇹🇭
Muang District, Thailand
1245.28.88001 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei, Taiwan
1245.28.35006 Boehringer Ingelheim Investigational Site
🇵🇹
Amadora, Portugal
1245.28.88004 Boehringer Ingelheim Investigational Site
🇨🇳
Changhua, Taiwan
1245.28.66007 Boehringer Ingelheim Investigational Site
🇹🇭
Bangkok, Thailand
1245.28.88003 Boehringer Ingelheim Investigational Site
🇨🇳
Taichung, Taiwan
1245.28.39021 Boehringer Ingelheim Investigational Site
🇮🇹
Cagliari, Italy
1245.28.39022 Boehringer Ingelheim Investigational Site
🇮🇹
Chieri (to), Italy
1245.28.39016 Boehringer Ingelheim Investigational Site
🇮🇹
Lucca, Italy
1245.28.39018 Boehringer Ingelheim Investigational Site
🇮🇹
Milano, Italy
1245.28.39019 Boehringer Ingelheim Investigational Site
🇮🇹
Milano, Italy
1245.28.39017 Boehringer Ingelheim Investigational Site
🇮🇹
Monserrato (ca), Italy
1245.28.39023 Boehringer Ingelheim Investigational Site
🇮🇹
Rimini, Italy
1245.28.39020 Boehringer Ingelheim Investigational Site
🇮🇹
Salerno, Italy
1245.28.44006 Boehringer Ingelheim Investigational Site
🇬🇧
Addlestone, United Kingdom
1245.28.44016 Boehringer Ingelheim Investigational Site
🇬🇧
Blackpool, United Kingdom
1245.28.44019 Boehringer Ingelheim Investigational Site
🇬🇧
Burbage, United Kingdom
1245.28.44027 Boehringer Ingelheim Investigational Site
🇬🇧
Chestfield, Whitstable, United Kingdom
1245.28.44011 Boehringer Ingelheim Investigational Site
🇬🇧
Chippenham, United Kingdom
1245.28.44043 Boehringer Ingelheim Investigational Site
🇬🇧
Coventry, United Kingdom
1245.28.44025 Boehringer Ingelheim Investigational Site
🇬🇧
Doncaster, United Kingdom
1245.28.44030 Boehringer Ingelheim Investigational Site
🇬🇧
Ely, United Kingdom
1245.28.44023 Boehringer Ingelheim Investigational Site
🇬🇧
Nantwich, United Kingdom
1245.28.44017 Boehringer Ingelheim Investigational Site
🇬🇧
Whitstable, United Kingdom
1245.28.46001 Boehringer Ingelheim Investigational Site
🇸🇪
Malmö, Sweden
1245.28.46004 Boehringer Ingelheim Investigational Site
🇸🇪
Uppsala, Sweden
1245.28.46005 Boehringer Ingelheim Investigational Site
🇸🇪
Örebro, Sweden
1245.28.20005 Boehringer Ingelheim Investigational Site
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Strathroy, Ontario, Canada
1245.28.20083 Boehringer Ingelheim Investigational Site
🇨🇦
Sudbury, Ontario, Canada
1245.28.34006 Boehringer Ingelheim Investigational Site
🇪🇸
Tarrega - Lleida, Spain
1245.28.10015 Boehringer Ingelheim Investigational Site
🇺🇸
Tampa, Florida, United States
1245.28.10007 Boehringer Ingelheim Investigational Site
🇺🇸
Omaha, Nebraska, United States
1245.28.10017 Boehringer Ingelheim Investigational Site
🇺🇸
Portland, Oregon, United States
1245.28.10006 Boehringer Ingelheim Investigational Site
🇺🇸
Shelby, North Carolina, United States
1245.28.10004 Boehringer Ingelheim Investigational Site
🇺🇸
Columbus, Ohio, United States
1245.28.10032 Boehringer Ingelheim Investigational Site
🇺🇸
Longview, Texas, United States
1245.28.10020 Boehringer Ingelheim Investigational Site
🇺🇸
Medford, Oregon, United States
1245.28.10031 Boehringer Ingelheim Investigational Site
🇺🇸
Dallas, Texas, United States
1245.28.10022 Boehringer Ingelheim Investigational Site
🇺🇸
San Antonio, Texas, United States
1245.28.10008 Boehringer Ingelheim Investigational Site
🇺🇸
Perrysburg, Ohio, United States
1245.28.20075 Boehringer Ingelheim Investigational Site
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Edmonton, Alberta, Canada
1245.28.85201 Boehringer Ingelheim Investigational Site
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Hong Kong, Hong Kong
1245.28.85202 Boehringer Ingelheim Investigational Site
🇭🇰
Kowloon, Hong Kong
1245.28.85207 Boehringer Ingelheim Investigational Site
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Hong Kong, Hong Kong