Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: BI 10773 open label
Drug: BI 10773
Drug: BI10773
Drug: Sitagliptin
Drug: Placebo identical to BI10773 low dose
Drug: Placebo identical to Sitagliptin 100mg
Drug: Placebo identical to BI10773 high dose

Registration Number: NCT01177813

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 986

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin 100 mg	Placebo identical to BI10773 low dose	Patients receive Sitagliptin 100 mg tablets once daily
BI 10773 high dose open label	BI 10773 open label	Patients receive BI 10773 high dose tablets open label once daily
BI 10773 low dose	BI 10773	Patients receive BI 10773 low dose tablets once daily
BI 10773 high dose	BI10773	Patients receive BI 10773 high dose tablets once daily
BI 10773 high dose	Placebo identical to Sitagliptin 100mg	Patients receive BI 10773 high dose tablets once daily
Placebo	Placebo identical to BI10773 low dose	Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
Placebo	Placebo identical to Sitagliptin 100mg	Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
Placebo	Placebo identical to BI10773 high dose	Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
Sitagliptin 100 mg	Placebo identical to BI10773 high dose	Patients receive Sitagliptin 100 mg tablets once daily
Sitagliptin 100 mg	Sitagliptin	Patients receive Sitagliptin 100 mg tablets once daily
BI 10773 low dose	Placebo identical to BI10773 high dose	Patients receive BI 10773 low dose tablets once daily
BI 10773 low dose	Placebo identical to Sitagliptin 100mg	Patients receive BI 10773 low dose tablets once daily
BI 10773 high dose	Placebo identical to BI10773 low dose	Patients receive BI 10773 high dose tablets once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks	Baseline and day 169	The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 24 in Body Weight	Baseline and day 169	The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)	Baseline and week 24	The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.

Trial Locations

Locations (124): 1245.20.32016 Boehringer Ingelheim Investigational Site
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Deurne, Belgium
1245.20.10154 Boehringer Ingelheim Investigational Site
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Chino, California, United States
1245.20.10078 Boehringer Ingelheim Investigational Site
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Tampa, Florida, United States
1245.20.32025 Boehringer Ingelheim Investigational Site
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Gozée, Belgium
1245.20.86020 Boehringer Ingelheim Investigational Site
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Hangzhou, China
1245.20.91005 Boehringer Ingelheim Investigational Site
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Bangalore, India
1245.20.91006 Boehringer Ingelheim Investigational Site
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Bangalore, India
1245.20.49013 Boehringer Ingelheim Investigational Site
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Dresden, Germany
1245.20.49016 Boehringer Ingelheim Investigational Site
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Düsseldorf, Germany
1245.20.49015 Boehringer Ingelheim Investigational Site
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Frankfurt, Germany
1245.20.49008 Boehringer Ingelheim Investigational Site
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Nürnberg, Germany
1245.20.49019 Boehringer Ingelheim Investigational Site
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Haag, Germany
1245.20.49022 Boehringer Ingelheim Investigational Site
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Schauenburg, Germany
1245.20.49014 Boehringer Ingelheim Investigational Site
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Köthen, Germany
1245.20.49002 Boehringer Ingelheim Investigational Site
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Neuwied, Germany
1245.20.49017 Boehringer Ingelheim Investigational Site
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St. Ingbert/Oberwürzbach, Germany
1245.20.49020 Boehringer Ingelheim Investigational Site
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Hohenmölsen, Germany
1245.20.81002 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo, Japan
1245.20.32008 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
1245.20.32003 Boehringer Ingelheim Investigational Site
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De Pinte, Belgium
1245.20.91004 Boehringer Ingelheim Investigational Site
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Chennai, India
1245.20.91009 Boehringer Ingelheim Investigational Site
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Chennai, India
1245.20.86003 Boehringer Ingelheim Investigational Site
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Guangzhou, China
1245.20.86016 Boehringer Ingelheim Investigational Site
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QingDao, China
1245.20.86043 Boehringer Ingelheim Investigational Site
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Nanjing, China
1245.20.86004 Boehringer Ingelheim Investigational Site
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Shanghai, China
1245.20.86005 Boehringer Ingelheim Investigational Site
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Shanghai, China
1245.20.86057 Boehringer Ingelheim Investigational Site
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Shenyang, China
1245.20.86013 Boehringer Ingelheim Investigational Site
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Suzhou, China
1245.20.86015 Boehringer Ingelheim Investigational Site
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Taiyuan, China
1245.20.86006 Boehringer Ingelheim Investigational Site
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Shanghai, China
1245.20.86017 Boehringer Ingelheim Investigational Site
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Shiyan, China
1245.20.86014 Boehringer Ingelheim Investigational Site
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Xiamen, China
1245.20.10124 Boehringer Ingelheim Investigational Site
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Mesa, Arizona, United States
1245.20.10108 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
1245.20.10045 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, United States
1245.20.10119 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, United States
1245.20.10089 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
1245.20.10009 Boehringer Ingelheim Investigational Site
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Santa Ana, California, United States
1245.20.10006 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
1245.20.10085 Boehringer Ingelheim Investigational Site
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Plantation, Florida, United States
1245.20.10065 Boehringer Ingelheim Investigational Site
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Indianapolis, Indiana, United States
1245.20.10155 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
1245.20.20018 Boehringer Ingelheim Investigational Site
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Victoria, British Columbia, Canada
1245.20.20012 Boehringer Ingelheim Investigational Site
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Moncton, New Brunswick, Canada
1245.20.20003 Boehringer Ingelheim Investigational Site
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Markham, Ontario, Canada
1245.20.20009 Boehringer Ingelheim Investigational Site
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Newmarket, Ontario, Canada
1245.20.20006 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
1245.20.10131 Boehringer Ingelheim Investigational Site
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West Hills, California, United States
1245.20.10137 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
1245.20.10060 Boehringer Ingelheim Investigational Site
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Fishers, Indiana, United States
1245.20.10080 Boehringer Ingelheim Investigational Site
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Decatur, Georgia, United States
1245.20.10039 Boehringer Ingelheim Investigational Site
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Wichita, Kansas, United States
1245.20.10146 Boehringer Ingelheim Investigational Site
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Louisville, Kentucky, United States
1245.20.10115 Boehringer Ingelheim Investigational Site
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Brick, New Jersey, United States
1245.20.10129 Boehringer Ingelheim Investigational Site
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Carlisle, Ohio, United States
1245.20.10130 Boehringer Ingelheim Investigational Site
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Gallipolis, Ohio, United States
1245.20.32011 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
1245.20.32023 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
1245.20.32015 Boehringer Ingelheim Investigational Site
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Deurne, Belgium
1245.20.32022 Boehringer Ingelheim Investigational Site
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Landen, Belgium
1245.20.32019 Boehringer Ingelheim Investigational Site
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Leopoldsburg, Belgium
1245.20.32024 Boehringer Ingelheim Investigational Site
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Linkebeek, Belgium
1245.20.32021 Boehringer Ingelheim Investigational Site
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Mouscron, Belgium
1245.20.32027 Boehringer Ingelheim Investigational Site
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Retie, Belgium
1245.20.32020 Boehringer Ingelheim Investigational Site
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Sint-Gillis-Waas, Belgium
1245.20.32018 Boehringer Ingelheim Investigational Site
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Tielt, Belgium
1245.20.32026 Boehringer Ingelheim Investigational Site
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Tremelo, Belgium
1245.20.20011 Boehringer Ingelheim Investigational Site
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Chilliwack, British Columbia, Canada
1245.20.20015 Boehringer Ingelheim Investigational Site
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Winnipeg, Manitoba, Canada
1245.20.20008 Boehringer Ingelheim Investigational Site
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St. John's, Newfoundland and Labrador, Canada
1245.20.20001 Boehringer Ingelheim Investigational Site
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Barrie, Ontario, Canada
1245.20.20019 Boehringer Ingelheim Investigational Site
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Hamilton, Ontario, Canada
1245.20.20017 Boehringer Ingelheim Investigational Site
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London, Ontario, Canada
1245.20.20010 Boehringer Ingelheim Investigational Site
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London, Ontario, Canada
1245.20.20005 Boehringer Ingelheim Investigational Site
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Strathroy, Ontario, Canada
1245.20.20002 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
1245.20.20014 Boehringer Ingelheim Investigational Site
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Charlottetown, Prince Edward Island, Canada
1245.20.20007 Boehringer Ingelheim Investigational Site
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Montague, Prince Edward Island, Canada
1245.20.86008 Boehringer Ingelheim Investigational Site
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Beijing, China
1245.20.86001 Boehringer Ingelheim Investigational Site
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Guangzhou, China
1245.20.20021 Boehringer Ingelheim Investigational Site
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Trois Rivieres, Quebec, Canada
1245.20.86007 Boehringer Ingelheim Investigational Site
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Beijing, China
1245.20.86002 Boehringer Ingelheim Investigational Site
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Guangzhou, China
1245.20.86012 Boehringer Ingelheim Investigational Site
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Guiyang, China
1245.20.86049 Boehringer Ingelheim Investigational Site
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Jinan, China
1245.20.86018 Boehringer Ingelheim Investigational Site
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Jingzhou, China
1245.20.86019 Boehringer Ingelheim Investigational Site
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Nanchang, China
1245.20.86011 Boehringer Ingelheim Investigational Site
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Xi'An, China
1245.20.86009 Boehringer Ingelheim Investigational Site
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Wuhan, China
1245.20.49003 Boehringer Ingelheim Investigational Site
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Unterschneidheim, Germany
1245.20.91001 Boehringer Ingelheim Investigational Site
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Tamil Nadu, India
1245.20.35302 Boehringer Ingelheim Investigational Site
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Co. Cork, Ireland
1245.20.35303 Boehringer Ingelheim Investigational Site
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Co. Wexford, Ireland
1245.20.35304 Boehringer Ingelheim Investigational Site
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Offaly, Ireland
1245.20.35306 Boehringer Ingelheim Investigational Site
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Wexford, Ireland
1245.20.81001 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo, Japan
1245.20.81007 Boehringer Ingelheim Investigational Site
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Chiyoda-ku, Tokyo, Japan
1245.20.81005 Boehringer Ingelheim Investigational Site
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Ebetsu, Hokkaido, Japan
1245.20.81003 Boehringer Ingelheim Investigational Site
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Minato-ku, Tokyo, Japan
1245.20.81004 Boehringer Ingelheim Investigational Site
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Kamakura, Kanagawa, Japan
1245.20.81006 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Japan
1245.20.35305 Boehringer Ingelheim Investigational Site
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Co. Galway, Ireland
1245.20.81010 Boehringer Ingelheim Investigational Site
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Ube, Yamaguchi, Japan
1245.20.81009 Boehringer Ingelheim Investigational Site
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Suita, Osaka, Japan
1245.20.81012 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Japan
1245.20.41003 Boehringer Ingelheim Investigational Site
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Rorschach, Switzerland
1245.20.81013 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Japan
1245.20.41004 Boehringer Ingelheim Investigational Site
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Lugano, Switzerland
1245.20.10150 Boehringer Ingelheim Investigational Site
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Hot Springs, Arkansas, United States
1245.20.10038 Boehringer Ingelheim Investigational Site
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Northglenn, Colorado, United States
1245.20.10144 Boehringer Ingelheim Investigational Site
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Watertown, Massachusetts, United States
1245.20.10151 Boehringer Ingelheim Investigational Site
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Hurst, Texas, United States
1245.20.20013 Boehringer Ingelheim Investigational Site
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Ottawa, Ontario, Canada
1245.20.81008 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Japan
1245.20.91007 Boehringer Ingelheim Investigational Site
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Mumbai, Maharastra, India
1245.20.91002 Boehringer Ingelheim Investigational Site
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Mumbai, India
1245.20.91008 Boehringer Ingelheim Investigational Site
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Bangalore, India
1245.20.91003 Boehringer Ingelheim Investigational Site
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Belgaum, India
1245.20.91010 Boehringer Ingelheim Investigational Site
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Nagpur, India
1245.20.20016 Boehringer Ingelheim Investigational Site
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Mount Pearl, Newfoundland and Labrador, Canada
1245.20.10128 Boehringer Ingelheim Investigational Site
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Avon, Indiana, United States
1245.20.10117 Boehringer Ingelheim Investigational Site
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Arkansas City, Kansas, United States
1245.20.86010 Boehringer Ingelheim Investigational Site
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Nanjing, China