Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2
Hyperglycemia

Interventions: Drug: Metformin 500 mg bid
Drug: Empagliflozin low dose bid
Drug: Metformin 1000 mg bid
Drug: Empagliflozin low dose qd
Drug: Empagliflozin high dose qd
Drug: Empagliflozin high dose bid

Registration Number: NCT01719003

Lead Sponsor: Boehringer Ingelheim

Brief Summary: This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1413

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin high dose + met 1000mg bid	Empagliflozin high dose bid	Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
Empagliflozin high dose + met 500 mg bid	Metformin 500 mg bid	Empagliflozin high dose split twice daily + metformin 500 mg twice daily
Empagliflozin low dose + met 1000 mg bid	Empagliflozin low dose bid	Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
OL empa high dose + met 1000 mg bid	Empagliflozin high dose bid	Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.
OL empa high dose + met 1000 mg bid	Metformin 1000 mg bid	Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.
Empagliflozin low dose + met 1000 mg bid	Metformin 1000 mg bid	Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
Empagliflozin low dose + met 500 mg bid	Metformin 500 mg bid	Empagliflozin low dose split twice daily + metformin 500 mg twice daily
Empagliflozin high dose + met 1000mg bid	Metformin 1000 mg bid	Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
Metformin 500 mg bid	Metformin 500 mg bid	Metformin 500 mg twice daily
Empagliflozin low dose qd	Empagliflozin low dose qd	Empagliflozin low dose once daily
Empagliflozin high dose qd	Empagliflozin high dose qd	Empagliflozin high dose once daily
Empagliflozin low dose + met 500 mg bid	Empagliflozin low dose bid	Empagliflozin low dose split twice daily + metformin 500 mg twice daily
Empagliflozin high dose + met 500 mg bid	Empagliflozin high dose bid	Empagliflozin high dose split twice daily + metformin 500 mg twice daily
Metformin 1000 mg bid	Metformin 1000 mg bid	Metformin 1000 mg twice daily

Primary Outcome Measures

Name	Time	Method
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24	baseline and 24 weeks	Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means

Secondary Outcome Measures

Name	Time	Method
FPG (Fasting Plasma Glucose) Change From Baseline at Week 24	baseline and 24 weeks	Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.
Body Weight Change From Baseline at Week 24	baseline and 24 weeks	Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.

Trial Locations

Locations (190): 1276.1.10010 Boehringer Ingelheim Investigational Site
🇺🇸
Glendale, Arizona, United States
1276.1.10008 Boehringer Ingelheim Investigational Site
🇺🇸
Greer, South Carolina, United States
1276.1.50005 Boehringer Ingelheim Investigational Site
🇬🇹
Guatemala, Guatemala
1276.1.50006 Boehringer Ingelheim Investigational Site
🇬🇹
Guatemala, Guatemala
1276.1.60001 Boehringer Ingelheim Investigational Site
🇲🇾
Johor Bahru, Malaysia
1276.1.51004 Boehringer Ingelheim Investigational Site
🇵🇪
Lima, Peru
1276.1.63009 Boehringer Ingelheim Investigational Site
🇵🇭
Cebu City, Cebu, Philippines
1276.1.63006 Boehringer Ingelheim Investigational Site
🇵🇭
Manila, Philippines
1276.1.63001 Boehringer Ingelheim Investigational Site
🇵🇭
Marikina City, Philippines
1276.1.63007 Boehringer Ingelheim Investigational Site
🇵🇭
San Juan City, Philippines
1276.1.63008 Boehringer Ingelheim Investigational Site
🇵🇭
Tarlac, Philippines
1276.1.70018 Boehringer Ingelheim Investigational Site
🇷🇺
Novosibirsk, Russian Federation
1276.1.70007 Boehringer Ingelheim Investigational Site
🇷🇺
Petrozavodsk, Russian Federation
1276.1.38103 Boehringer Ingelheim Investigational Site
🇷🇸
Kragujevac, Serbia
1276.1.38102 Boehringer Ingelheim Investigational Site
🇷🇸
Zajecar, Serbia
1276.1.88005 Boehringer Ingelheim Investigational Site
🇨🇳
Kaohsiung City,, Taiwan
1276.1.88002 Boehringer Ingelheim Investigational Site
🇨🇳
New Taipei City, Taiwan
1276.1.66003 Boehringer Ingelheim Investigational Site
🇹🇭
Bangkok, Thailand, Thailand
1276.1.90003 Boehringer Ingelheim Investigational Site
🇹🇷
Ankara, Turkey
1276.1.66001 Boehringer Ingelheim Investigational Site
🇹🇭
Bangkok, Thailand, Thailand
1276.1.88006 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei, Taiwan
1276.1.66002 Boehringer Ingelheim Investigational Site
🇹🇭
Nakhon Ratchasima, Thailand
1276.1.10032 Boehringer Ingelheim Investigational Site
🇺🇸
Fall River, Massachusetts, United States
1276.1.10023 Boehringer Ingelheim Investigational Site
🇺🇸
Marietta, Georgia, United States
1276.1.10030 Boehringer Ingelheim Investigational Site
🇺🇸
Columbia, South Carolina, United States
1276.1.96004 Boehringer Ingelheim Investigational Site
🇱🇧
Saida, Lebanon
1276.1.20001 Boehringer Ingelheim Investigational Site
🇨🇦
Saskatoon, Saskatchewan, Canada
1276.1.20007 Boehringer Ingelheim Investigational Site
🇨🇦
Mirabel, Quebec, Canada
1276.1.42002 Boehringer Ingelheim Investigational Site
🇨🇿
Benatky nad Jizerou, Czech Republic
1276.1.42010 Boehringer Ingelheim Investigational Site
🇨🇿
Praha 1, Czech Republic
1276.1.95003 Boehringer Ingelheim Investigational Site
🇪🇬
Al Manial, Cairo, Egypt, Egypt
1276.1.10044 Boehringer Ingelheim Investigational Site
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Hot Springs, Alaska, United States
1276.1.10046 Boehringer Ingelheim Investigational Site
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Chula Vista, California, United States
1276.1.10006 Boehringer Ingelheim Investigational Site
🇺🇸
Huntington Beach, California, United States
1276.1.10035 Boehringer Ingelheim Investigational Site
🇺🇸
Searcy, Arkansas, United States
1276.1.10009 Boehringer Ingelheim Investigational Site
🇺🇸
Los Angeles, California, United States
1276.1.10043 Boehringer Ingelheim Investigational Site
🇺🇸
La Mesa, California, United States
1276.1.10045 Boehringer Ingelheim Investigational Site
🇺🇸
Oceanside, California, United States
1276.1.10040 Boehringer Ingelheim Investigational Site
🇺🇸
Los Angeles, California, United States
1276.1.10024 Boehringer Ingelheim Investigational Site
🇺🇸
Oldsmar, Florida, United States
1276.1.10026 Boehringer Ingelheim Investigational Site
🇺🇸
Fort Lauderdale, Florida, United States
1276.1.10003 Boehringer Ingelheim Investigational Site
🇺🇸
Northglenn, Colorado, United States
1276.1.10027 Boehringer Ingelheim Investigational Site
🇺🇸
Port Orange, Florida, United States
1276.1.20002 Boehringer Ingelheim Investigational Site
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Quebec, Canada
1276.1.10034 Boehringer Ingelheim Investigational Site
🇺🇸
Evansville, Indiana, United States
1276.1.10015 Boehringer Ingelheim Investigational Site
🇺🇸
Union, New Jersey, United States
1276.1.10036 Boehringer Ingelheim Investigational Site
🇺🇸
Bridgman, Michigan, United States
1276.1.10037 Boehringer Ingelheim Investigational Site
🇺🇸
Hazelwood, Missouri, United States
1276.1.10033 Boehringer Ingelheim Investigational Site
🇺🇸
Asheboro, North Carolina, United States
1276.1.10022 Boehringer Ingelheim Investigational Site
🇺🇸
Burlington, North Carolina, United States
1276.1.10011 Boehringer Ingelheim Investigational Site
🇺🇸
Gallipolis, Ohio, United States
1276.1.10002 Boehringer Ingelheim Investigational Site
🇺🇸
Lenoir, North Carolina, United States
1276.1.10013 Boehringer Ingelheim Investigational Site
🇺🇸
Hodges, South Carolina, United States
1276.1.10018 Boehringer Ingelheim Investigational Site
🇺🇸
Houston, Texas, United States
1276.1.10017 Boehringer Ingelheim Investigational Site
🇺🇸
Humboldt, Tennessee, United States
1276.1.10016 Boehringer Ingelheim Investigational Site
🇺🇸
Kingwood, Texas, United States
1276.1.10025 Boehringer Ingelheim Investigational Site
🇺🇸
Houston, Texas, United States
1276.1.10028 Boehringer Ingelheim Investigational Site
🇺🇸
Houston, Texas, United States
1276.1.10012 Boehringer Ingelheim Investigational Site
🇺🇸
Wenatchee, Washington, United States
1276.1.10004 Boehringer Ingelheim Investigational Site
🇺🇸
Manassas, Virginia, United States
1276.1.55008 Boehringer Ingelheim Investigational Site
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Belém, Brazil
1276.1.55003 Boehringer Ingelheim Investigational Site
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Brasilia, Brazil
1276.1.55004 Boehringer Ingelheim Investigational Site
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Goiania, Brazil
1276.1.55006 Boehringer Ingelheim Investigational Site
🇧🇷
Fortaleza, Brazil
1276.1.55007 Boehringer Ingelheim Investigational Site
🇧🇷
Fortaleza, Brazil
1276.1.55009 Boehringer Ingelheim Investigational Site
🇧🇷
Fortaleza, Brazil
1276.1.55002 Boehringer Ingelheim Investigational Site
🇧🇷
Porto Alegre, Brazil
1276.1.55001 Boehringer Ingelheim Investigational Site
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Sao Paulo, Brazil
1276.1.20003 Boehringer Ingelheim Investigational Site
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Coquitlam, British Columbia, Canada
1276.1.20012 Boehringer Ingelheim Investigational Site
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Coquitlam, British Columbia, Canada
1276.1.20008 Boehringer Ingelheim Investigational Site
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Victoria, British Columbia, Canada
1276.1.20005 Boehringer Ingelheim Investigational Site
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Hawkesbury, Ontario, Canada
1276.1.20004 Boehringer Ingelheim Investigational Site
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Antigonish, Nova Scotia, Canada
1276.1.20010 Boehringer Ingelheim Investigational Site
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Strathroy, Ontario, Canada
1276.1.20006 Boehringer Ingelheim Investigational Site
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Thornhill, Ontario, Canada
1276.1.20013 Boehringer Ingelheim Investigational Site
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Sarnia, Ontario, Canada
1276.1.42008 Boehringer Ingelheim Investigational Site
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Olomouc, Czech Republic
1276.1.42004 Boehringer Ingelheim Investigational Site
🇨🇿
Praha 10, Czech Republic
1276.1.42007 Boehringer Ingelheim Investigational Site
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Ostrava, Czech Republic
1276.1.42009 Boehringer Ingelheim Investigational Site
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Plzen, Czech Republic
1276.1.42003 Boehringer Ingelheim Investigational Site
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Praha 3, Czech Republic
1276.1.95004 Boehringer Ingelheim Investigational Site
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Alexandria, Egypt
1276.1.95001 Boehringer Ingelheim Investigational Site
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Abbasia Cairo, Egypt, Egypt
1276.1.95002 Boehringer Ingelheim Investigational Site
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El Darasa Cairo Egypt, Egypt
1276.1.33004 Boehringer Ingelheim Investigational Site
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Behren Les Forbach, France
1276.1.33012 Boehringer Ingelheim Investigational Site
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Bersée, France
1276.1.33007 Boehringer Ingelheim Investigational Site
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Hautmont, France
1276.1.33001 Boehringer Ingelheim Investigational Site
🇫🇷
Poitiers, France
1276.1.33003 Boehringer Ingelheim Investigational Site
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Savonnières, France
1276.1.33013 Boehringer Ingelheim Investigational Site
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Paris, France
1276.1.33002 Boehringer Ingelheim Investigational Site
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Thouars, France
1276.1.33006 Boehringer Ingelheim Investigational Site
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St Genis des Fontaines, France
1276.1.33011 Boehringer Ingelheim Investigational Site
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Thun St amand, France
1276.1.33010 Boehringer Ingelheim Investigational Site
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Tours, France
1276.1.33008 Boehringer Ingelheim Investigational Site
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Vieux Condé, France
1276.1.33009 Boehringer Ingelheim Investigational Site
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Vandome, France
1276.1.49005 Boehringer Ingelheim Investigational Site
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Berlin, Germany
1276.1.49008 Boehringer Ingelheim Investigational Site
🇩🇪
Celle, Germany
1276.1.49006 Boehringer Ingelheim Investigational Site
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Dortmund, Germany
1276.1.49011 Boehringer Ingelheim Investigational Site
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Dresden, Germany
1276.1.49003 Boehringer Ingelheim Investigational Site
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Essen, Germany
1276.1.49014 Boehringer Ingelheim Investigational Site
🇩🇪
Neuwied, Germany
1276.1.49002 Boehringer Ingelheim Investigational Site
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Stuhr-Brinkum, Germany
1276.1.49004 Boehringer Ingelheim Investigational Site
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Offenbach, Germany
1276.1.50002 Boehringer Ingelheim Investigational Site
🇬🇹
Barbena Santa Rosa, Guatemala
1276.1.49012 Boehringer Ingelheim Investigational Site
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Teuchern, Germany
1276.1.50003 Boehringer Ingelheim Investigational Site
🇬🇹
Guatemala, Guatemala
1276.1.50001 Boehringer Ingelheim Investigational Site
🇬🇹
Quetzaltenango, Guatemala
1276.1.82006 Boehringer Ingelheim Investigational Site
🇰🇷
Deagu, Korea, Republic of
1276.1.82010 Boehringer Ingelheim Investigational Site
🇰🇷
Goyang, Korea, Republic of
1276.1.82009 Boehringer Ingelheim Investigational Site
🇰🇷
Pusan, Korea, Republic of
1276.1.82004 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1276.1.82005 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1276.1.96002 Boehringer Ingelheim Investigational Site
🇱🇧
El Chouf, Lebanon
1276.1.82007 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1276.1.82002 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1276.1.96001 Boehringer Ingelheim Investigational Site
🇱🇧
Beirut, Lebanon
1276.1.96003 Boehringer Ingelheim Investigational Site
🇱🇧
Saida, Lebanon
1276.1.82003 Boehringer Ingelheim Investigational Site
🇰🇷
Wonju, Korea, Republic of
1276.1.82008 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1276.1.60002 Boehringer Ingelheim Investigational Site
🇲🇾
Ipoh, Perak, Malaysia
1276.1.60003 Boehringer Ingelheim Investigational Site
🇲🇾
Kubang Kerian, Malaysia
1276.1.52004 Boehringer Ingelheim Investigational Site
🇲🇽
Aguascalientes, Mexico
1276.1.52002 Boehringer Ingelheim Investigational Site
🇲🇽
Ciudad de Mexico, Mexico
1276.1.52003 Boehringer Ingelheim Investigational Site
🇲🇽
Guadalajara, Mexico
1276.1.52007 Boehringer Ingelheim Investigational Site
🇲🇽
Aguascalientes, Mexico
1276.1.52005 Boehringer Ingelheim Investigational Site
🇲🇽
Zapopan, Mexico
1276.1.52001 Boehringer Ingelheim Investigational Site
🇲🇽
Monterrey, Mexico
1276.1.52006 Boehringer Ingelheim Investigational Site
🇲🇽
San Lucas tepetlcalco, Mexico
1276.1.51001 Boehringer Ingelheim Investigational Site
🇵🇪
Lima, Peru
1276.1.51003 Boehringer Ingelheim Investigational Site
🇵🇪
Lima, Peru
1276.1.51005 Boehringer Ingelheim Investigational Site
🇵🇪
Lima, Peru
1276.1.63002 Boehringer Ingelheim Investigational Site
🇵🇭
Cebu City, Philippines, Philippines
1276.1.70017 Boehringer Ingelheim Investigational Site
🇷🇺
St. Petersburg, Russian Federation
1276.1.34027 Boehringer Ingelheim Investigational Site
🇪🇸
Salamanca, Spain
1276.1.90006 Boehringer Ingelheim Investigational Site
🇹🇷
Denizli, Turkey
1276.1.90001 Boehringer Ingelheim Investigational Site
🇹🇷
Izmir, Turkey
1276.1.44006 Boehringer Ingelheim Investigational Site
🇬🇧
Dagenham, United Kingdom
1276.1.44003 Boehringer Ingelheim Investigational Site
🇬🇧
Leeds, United Kingdom
1276.1.44007 Boehringer Ingelheim Investigational Site
🇬🇧
Manchester, United Kingdom
1276.1.44004 Boehringer Ingelheim Investigational Site
🇬🇧
Doncaster, United Kingdom
1276.1.44011 Boehringer Ingelheim Investigational Site
🇬🇧
Mortimer, United Kingdom
1276.1.44009 Boehringer Ingelheim Investigational Site
🇬🇧
Sandbach, United Kingdom
1276.1.10042 Boehringer Ingelheim Investigational Site
🇺🇸
Colorado Springs, Colorado, United States
1276.1.33005 Boehringer Ingelheim Investigational Site
🇫🇷
Cournonterral, France
1276.1.82001 Boehringer Ingelheim Investigational Site
🇰🇷
Incheon, Korea, Republic of
1276.1.10019 Boehringer Ingelheim Investigational Site
🇺🇸
Birmingham, Alabama, United States
1276.1.10014 Boehringer Ingelheim Investigational Site
🇺🇸
Birmingham, Alabama, United States
1276.1.10001 Boehringer Ingelheim Investigational Site
🇺🇸
Denver, Colorado, United States
1276.1.10007 Boehringer Ingelheim Investigational Site
🇺🇸
Las Vegas, Nevada, United States
1276.1.10005 Boehringer Ingelheim Investigational Site
🇺🇸
Cincinnati, Ohio, United States
1276.1.10021 Boehringer Ingelheim Investigational Site
🇺🇸
San Antonio, Texas, United States
1276.1.10041 Boehringer Ingelheim Investigational Site
🇺🇸
San Antonio, Texas, United States
1276.1.49007 Boehringer Ingelheim Investigational Site
🇩🇪
Ingelheim, Germany
1276.1.51002 Boehringer Ingelheim Investigational Site
🇵🇪
Lima, Peru
1276.1.63004 Boehringer Ingelheim Investigational Site
🇵🇭
Davao City, Philippines
1276.1.63003 Boehringer Ingelheim Investigational Site
🇵🇭
Iloilo City, Philippines
1276.1.63005 Boehringer Ingelheim Investigational Site
🇵🇭
Maybunga, Pasig City, Philippines
1276.1.70012 Boehringer Ingelheim Investigational Site
🇷🇺
Barnaul, Russian Federation
1276.1.38101 Boehringer Ingelheim Investigational Site
🇷🇸
Nis, Serbia
1276.1.88001 Boehringer Ingelheim Investigational Site
🇨🇳
Taichung, Taiwan
1276.1.34050 Boehringer Ingelheim Investigational Site
🇪🇸
Alzira, Spain
1276.1.34052 Boehringer Ingelheim Investigational Site
🇪🇸
Tarragona, Spain
1276.1.70011 Boehringer Ingelheim Investigational Site
🇷🇺
Kemerovo, Russian Federation
1276.1.44005 Boehringer Ingelheim Investigational Site
🇬🇧
Chippenham, United Kingdom
1276.1.34051 Boehringer Ingelheim Investigational Site
🇪🇸
Zaragoza, Spain
1276.1.70015 Boehringer Ingelheim Investigational Site
🇷🇺
Novosibirsk, Russian Federation
1276.1.70013 Boehringer Ingelheim Investigational Site
🇷🇺
Yaroslavl, Russian Federation
1276.1.38105 Boehringer Ingelheim Investigational Site
🇷🇸
Belgrade, Serbia
1276.1.38106 Boehringer Ingelheim Investigational Site
🇷🇸
Belgrade, Serbia
1276.1.38107 Boehringer Ingelheim Investigational Site
🇷🇸
Belgrade, Serbia
1276.1.34045 Boehringer Ingelheim Investigational Site
🇪🇸
pozuelo de Alarcon, Spain
1276.1.34028 Boehringer Ingelheim Investigational Site
🇪🇸
Madrid, Spain
1276.1.70016 Boehringer Ingelheim Investigational Site
🇷🇺
Novosibirsk, Russian Federation
1276.1.70009 Boehringer Ingelheim Investigational Site
🇷🇺
Saratov, Russian Federation
1276.1.70010 Boehringer Ingelheim Investigational Site
🇷🇺
Smolensk, Russian Federation
1276.1.70005 Boehringer Ingelheim Investigational Site
🇷🇺
St. Petersburg, Russian Federation
1276.1.38104 Boehringer Ingelheim Investigational Site
🇷🇸
Belgrade, Serbia
1276.1.88003 Boehringer Ingelheim Investigational Site
🇨🇳
Taichung, Taiwan
1276.1.70006 Boehringer Ingelheim Investigational Site
🇷🇺
St. Petersburg, Russian Federation
1276.1.38108 Boehringer Ingelheim Investigational Site
🇷🇸
Novi Sad, Serbia
1276.1.34048 Boehringer Ingelheim Investigational Site
🇪🇸
Alicante, Spain
1276.1.88004 Boehringer Ingelheim Investigational Site
🇨🇳
Taichung, Taiwan
1276.1.90004 Boehringer Ingelheim Investigational Site
🇹🇷
Antalya, Turkey
1276.1.90002 Boehringer Ingelheim Investigational Site
🇹🇷
Erzurum, Turkey
1276.1.90005 Boehringer Ingelheim Investigational Site
🇹🇷
Istanbul, Turkey
1276.1.44002 Boehringer Ingelheim Investigational Site
🇬🇧
Bolton, United Kingdom
1276.1.44001 Boehringer Ingelheim Investigational Site
🇬🇧
Bradford on Avon, United Kingdom
1276.1.44008 Boehringer Ingelheim Investigational Site
🇬🇧
Glasgow, United Kingdom
1276.1.34034 Boehringer Ingelheim Investigational Site
🇪🇸
Sabadell (Barcelona), Spain