Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
Public ClinicalTrials.gov record NCT01306214. 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, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.
Study identification
- NCT ID
- NCT01306214
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 566 participants
Conditions and interventions
Conditions
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
- Jan 31, 2011
- Primary completion
- Mar 31, 2013
- Completion
- Mar 31, 2013
- Last update posted
- Jun 16, 2014
2011 – 2013
United States locations
- U.S. sites
- 26
- U.S. states
- 17
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1245.49.10005 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1245.49.10011 Boehringer Ingelheim Investigational Site | Chandler | Arizona | — | — |
| 1245.49.10004 Boehringer Ingelheim Investigational Site | Tucson | Arizona | — | — |
| 1245.49.10002 Boehringer Ingelheim Investigational Site | Corona | California | — | — |
| 1245.49.10013 Boehringer Ingelheim Investigational Site | El Cajon | California | — | — |
| 1245.49.10030 Boehringer Ingelheim Investigational Site | Lomita | California | — | — |
| 1245.49.10014 Boehringer Ingelheim Investigational Site | Spring Valley | California | — | — |
| 1245.49.10019 Boehringer Ingelheim Investigational Site | Westlake Village | California | — | — |
| 1245.49.10024 Boehringer Ingelheim Investigational Site | Denver | Colorado | — | — |
| 1245.49.10018 Boehringer Ingelheim Investigational Site | Hialeah | Florida | — | — |
| 1245.49.10016 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1245.49.10021 Boehringer Ingelheim Investigational Site | Blue Ridge | Georgia | — | — |
| 1245.49.10009 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1245.49.10015 Boehringer Ingelheim Investigational Site | Evansville | Indiana | — | — |
| 1245.49.10023 Boehringer Ingelheim Investigational Site | Greenville | North Carolina | — | — |
| 1245.49.10007 Boehringer Ingelheim Investigational Site | Fargo | North Dakota | — | — |
| 1245.49.10006 Boehringer Ingelheim Investigational Site | Columbus | Ohio | — | — |
| 1245.49.10025 Boehringer Ingelheim Investigational Site | Greer | South Carolina | — | — |
| 1245.49.10022 Boehringer Ingelheim Investigational Site | Memphis | Tennessee | — | — |
| 1245.49.10003 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1245.49.10001 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1245.49.10031 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1245.49.10033 Boehringer Ingelheim Investigational Site | Bountiful | Utah | — | — |
| 1245.49.10032 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | — | — |
| 1245.49.10026 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | — | — |
| 1245.49.10020 Boehringer Ingelheim Investigational Site | Renton | 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 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01306214, 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 Jun 16, 2014 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01306214 live on ClinicalTrials.gov.