Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes
Public ClinicalTrials.gov record NCT01159600. 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 Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.
Study identification
- NCT ID
- NCT01159600
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,504 participants
Conditions and interventions
Conditions
Interventions
- Placebo identical to BI 10773 high dose Drug
- Placebo identical to BI 10773 low dose Drug
- BI 10773 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
- Jul 2010 (Type not available)
- Primary completion
- Feb 2012 (Actual)
- Completion
- Not listed
- Last update posted
- Jun 17, 2014
Started 2010
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1245.23.10145 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1245.23.10046 Boehringer Ingelheim Investigational Site | Tempe | Arizona | — | — |
| 1245.23.10095 Boehringer Ingelheim Investigational Site | Huntington Park | California | — | — |
| 1245.23.10109 Boehringer Ingelheim Investigational Site | Huntington Park | California | — | — |
| 1245.23.10074 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1245.23.10149 Boehringer Ingelheim Investigational Site | Rancho Cucamonga | California | — | — |
| 1245.23.10127 Boehringer Ingelheim Investigational Site | Waterbury | Connecticut | — | — |
| 1245.23.10042 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | — | — |
| 1245.23.10133 Boehringer Ingelheim Investigational Site | Jupiter | Florida | — | — |
| 1245.23.10080 Boehringer Ingelheim Investigational Site | Decatur | Georgia | — | — |
| 1245.23.10001 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1245.23.10159 Boehringer Ingelheim Investigational Site | Des Moines | Iowa | — | — |
| 1245.23.10117 Boehringer Ingelheim Investigational Site | Arkansas City | Kansas | — | — |
| 1245.23.10157 Boehringer Ingelheim Investigational Site | Newton | Kansas | — | — |
| 1245.23.10148 Boehringer Ingelheim Investigational Site | Lexington | Kentucky | — | — |
| 1245.23.10034 Boehringer Ingelheim Investigational Site | Rochester | New York | — | — |
| 1245.23.10123 Boehringer Ingelheim Investigational Site | Smithtown | New York | — | — |
| 1245.23.10120 Boehringer Ingelheim Investigational Site | Columbus | Ohio | — | — |
| 1245.23.10031 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 1245.23.10158 Boehringer Ingelheim Investigational Site | Mt. Pleasant | South Carolina | — | — |
| 1245.23.10015 Boehringer Ingelheim Investigational Site | Simpsonville | South Carolina | — | — |
| 1245.23.10156 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1245.23.10153 Boehringer Ingelheim Investigational Site | Hurst | Texas | — | — |
| 1245.23.10143 Boehringer Ingelheim Investigational Site | Killeen | Texas | — | — |
| 1245.23.10106 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
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 123 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01159600, 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 17, 2014 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01159600 live on ClinicalTrials.gov.