ClinicalTrials.gov record
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
ClinicalTrials.gov ID: NCT01422876
Public ClinicalTrials.gov record NCT01422876. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
Study identification
- NCT ID
- NCT01422876
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,405 participants
Conditions and interventions
Conditions
Interventions
- high dose FDC Drug
- BI 10773 high dose Drug
- high dose FDC placebo Drug
- low dose FDC placebo Drug
- high dose BI 10773 placebo Drug
- low dose FDC Drug
- BI 10773 low dose Drug
- linagliptin Drug
- linagliptin placebo Drug
- BI 10773 low dose placebo Drug
- low dose BI 10773 placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2011 (Type not available)
- Primary completion
- Sep 2013 (Actual)
- Completion
- Sep 2013 (Actual)
- Last update posted
- Apr 2, 2015
2011 – 2013
United States locations
- U.S. sites
- 112
- U.S. states
- 31
- U.S. cities
- 93
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1275.1.01103 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1275.1.01107 Boehringer Ingelheim Investigational Site | Foley | Alabama | — | — |
| 1275.1.01043 Boehringer Ingelheim Investigational Site | Mobile | Alabama | — | — |
| 1275.1.01066 Boehringer Ingelheim Investigational Site | Mobile | Alabama | — | — |
| 1275.1.01047 Boehringer Ingelheim Investigational Site | Pell City | Alabama | — | — |
| 1275.1.01089 Boehringer Ingelheim Investigational Site | Mesa | Arizona | — | — |
| 1275.1.01064 Boehringer Ingelheim Investigational Site | Tempe | Arizona | — | — |
| 1275.1.01028 Boehringer Ingelheim Investigational Site | Little Rock | Arkansas | — | — |
| 1275.1.01086 Boehringer Ingelheim Investigational Site | Cerritos | California | — | — |
| 1275.1.01067 Boehringer Ingelheim Investigational Site | Chula Vista | California | — | — |
| 1275.1.01109 Boehringer Ingelheim Investigational Site | Encino | California | — | — |
| 1275.1.01012 Boehringer Ingelheim Investigational Site | Fresno | California | — | — |
| 1275.1.01050 Boehringer Ingelheim Investigational Site | Harbor City | California | — | — |
| 1275.1.01056 Boehringer Ingelheim Investigational Site | Huntington Park | California | — | — |
| 1275.1.01021 Boehringer Ingelheim Investigational Site | Long Beach | California | — | — |
| 1275.1.01024 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1275.1.01112 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1275.1.01083 Boehringer Ingelheim Investigational Site | Oceanside | California | — | — |
| 1275.1.01071 Boehringer Ingelheim Investigational Site | San Dimas | California | — | — |
| 1275.1.01044 Boehringer Ingelheim Investigational Site | Tustin | California | — | — |
| 1275.1.01078 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | — | — |
| 1275.1.01124 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | — | — |
| 1275.1.01010 Boehringer Ingelheim Investigational Site | Denver | Colorado | — | — |
| 1275.1.01048 Boehringer Ingelheim Investigational Site | Denver | Colorado | — | — |
| 1275.1.01073 Boehringer Ingelheim Investigational Site | Gainesville | Florida | — | — |
| 1275.1.01063 Boehringer Ingelheim Investigational Site | Hialeah | Florida | — | — |
| 1275.1.01077 Boehringer Ingelheim Investigational Site | Hialeah | Florida | — | — |
| 1275.1.01090 Boehringer Ingelheim Investigational Site | Inverness | Florida | — | — |
| 1275.1.01054 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | — | — |
| 1275.1.01092 Boehringer Ingelheim Investigational Site | Maitland | Florida | — | — |
| 1275.1.01065 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1275.1.01110 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1275.1.01040 Boehringer Ingelheim Investigational Site | Miami Beach | Florida | — | — |
| 1275.1.01025 Boehringer Ingelheim Investigational Site | Miami Lakes | Florida | — | — |
| 1275.1.01094 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 1275.1.01068 Boehringer Ingelheim Investigational Site | Ormond Beach | Florida | — | — |
| 1275.1.01051 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | — | — |
| 1275.1.01079 Boehringer Ingelheim Investigational Site | Port Orange | Florida | — | — |
| 1275.1.01117 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | — | — |
| 1275.1.01039 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | — | — |
| 1275.1.01007 Boehringer Ingelheim Investigational Site | Marietta | Georgia | — | — |
| 1275.1.01111 Boehringer Ingelheim Investigational Site | Norcross | Georgia | — | — |
| 1275.1.01076 Boehringer Ingelheim Investigational Site | Savannah | Georgia | — | — |
| 1275.1.01100 Boehringer Ingelheim Investigational Site | Addison | Illinois | — | — |
| 1275.1.01042 Boehringer Ingelheim Investigational Site | Des Moines | Iowa | — | — |
| 1275.1.01059 Boehringer Ingelheim Investigational Site | Paducah | Kentucky | — | — |
| 1275.1.01003 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | — | — |
| 1275.1.01125 Boehringer Ingelheim Investigational Site | Hyattsville | Maryland | — | — |
| 1275.1.01081 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | — | — |
| 1275.1.01085 Boehringer Ingelheim Investigational Site | Rochester | Michigan | — | — |
| 1275.1.01035 Boehringer Ingelheim Investigational Site | Southfield | Michigan | — | — |
| 1275.1.01023 Boehringer Ingelheim Investigational Site | St Louis | Missouri | — | — |
| 1275.1.01027 Boehringer Ingelheim Investigational Site | St Louis | Missouri | — | — |
| 1275.1.01033 Boehringer Ingelheim Investigational Site | Great Falls | Montana | — | — |
| 1275.1.01099 Boehringer Ingelheim Investigational Site | Henderson | Nevada | — | — |
| 1275.1.01101 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | — | — |
| 1275.1.01114 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | — | — |
| 1275.1.01123 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | — | — |
| 1275.1.01013 Boehringer Ingelheim Investigational Site | Elizabeth | New Jersey | — | — |
| 1275.1.01057 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | — | — |
| 1275.1.01002 Boehringer Ingelheim Investigational Site | Binghamton | New York | — | — |
| 1275.1.01020 Boehringer Ingelheim Investigational Site | Endwell | New York | — | — |
| 1275.1.01095 Boehringer Ingelheim Investigational Site | Flushing | New York | — | — |
| 1275.1.01062 Boehringer Ingelheim Investigational Site | Glens Falls | New York | — | — |
| 1275.1.01006 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1275.1.01011 Boehringer Ingelheim Investigational Site | Asheboro | North Carolina | — | — |
| 1275.1.01052 Boehringer Ingelheim Investigational Site | Burlington | North Carolina | — | — |
| 1275.1.01045 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | — | — |
| 1275.1.01001 Boehringer Ingelheim Investigational Site | Akron | Ohio | — | — |
| 1275.1.01032 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1275.1.01061 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1275.1.01116 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1275.1.01016 Boehringer Ingelheim Investigational Site | Columbus | Ohio | — | — |
| 1275.1.01102 Boehringer Ingelheim Investigational Site | Columbus | Ohio | — | — |
| 1275.1.01017 Boehringer Ingelheim Investigational Site | Dayton | Ohio | — | — |
| 1275.1.01036 Boehringer Ingelheim Investigational Site | Dayton | Ohio | — | — |
| 1275.1.01030 Boehringer Ingelheim Investigational Site | Delaware | Ohio | — | — |
| 1275.1.01055 Boehringer Ingelheim Investigational Site | Groveport | Ohio | — | — |
| 1275.1.01075 Boehringer Ingelheim Investigational Site | Wadsworth | Ohio | — | — |
| 1275.1.01034 Boehringer Ingelheim Investigational Site | Norman | Oklahoma | — | — |
| 1275.1.01082 Boehringer Ingelheim Investigational Site | Corvallis | Oregon | — | — |
| 1275.1.01084 Boehringer Ingelheim Investigational Site | Altoona | Pennsylvania | — | — |
| 1275.1.01038 Boehringer Ingelheim Investigational Site | Fleetwood | Pennsylvania | — | — |
| 1275.1.01019 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1275.1.01072 Boehringer Ingelheim Investigational Site | Scottdale | Pennsylvania | — | — |
| 1275.1.01088 Boehringer Ingelheim Investigational Site | Tipton | Pennsylvania | — | — |
| 1275.1.01014 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania | — | — |
| 1275.1.01060 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania | — | — |
| 1275.1.01093 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | — | — |
| 1275.1.01122 Boehringer Ingelheim Investigational Site | Florence | South Carolina | — | — |
| 1275.1.01005 Boehringer Ingelheim Investigational Site | Hodges | South Carolina | — | — |
| 1275.1.01015 Boehringer Ingelheim Investigational Site | Brentwood | Tennessee | — | — |
| 1275.1.01031 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee | — | — |
| 1275.1.01121 Boehringer Ingelheim Investigational Site | Memphis | Tennessee | — | — |
| 1275.1.01069 Boehringer Ingelheim Investigational Site | Spring Hill | Tennessee | — | — |
| 1275.1.01049 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1275.1.01080 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1275.1.01029 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1275.1.01053 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1275.1.01106 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1275.1.01018 Boehringer Ingelheim Investigational Site | Pearland | Texas | — | — |
| 1275.1.01096 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1275.1.01113 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1275.1.01120 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1275.1.01105 Boehringer Ingelheim Investigational Site | Spring | Texas | — | — |
| 1275.1.01037 Boehringer Ingelheim Investigational Site | Waco | Texas | — | — |
| 1275.1.01008 Boehringer Ingelheim Investigational Site | Bountiful | Utah | — | — |
| 1275.1.01022 Boehringer Ingelheim Investigational Site | West Jordan | Utah | — | — |
| 1275.1.01091 Boehringer Ingelheim Investigational Site | South Chesterfield | Virginia | — | — |
| 1275.1.01118 Boehringer Ingelheim Investigational Site | Selah | Washington | — | — |
| 1275.1.01087 Boehringer Ingelheim Investigational Site | Shoreline | Washington | — | — |
| 1275.1.01119 Boehringer Ingelheim Investigational Site | Spokane | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 99 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01422876, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 2, 2015 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01422876 live on ClinicalTrials.gov.