Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
Public ClinicalTrials.gov record NCT01177813. 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 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01177813
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 986 participants
Conditions and interventions
Conditions
Interventions
- Placebo identical to BI10773 high dose Drug
- BI 10773 Drug
- BI 10773 open label Drug
- Placebo identical to BI10773 low dose Drug
- Placebo identical to Sitagliptin 100mg Drug
- BI10773 Drug
- Sitagliptin 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
- Mar 2012 (Actual)
- Completion
- Not listed
- Last update posted
- Jun 16, 2014
Started 2010
United States locations
- U.S. sites
- 27
- U.S. states
- 13
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1245.20.10124 Boehringer Ingelheim Investigational Site | Mesa | Arizona | — | — |
| 1245.20.10108 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | — | — |
| 1245.20.10150 Boehringer Ingelheim Investigational Site | Hot Springs | Arkansas | — | — |
| 1245.20.10154 Boehringer Ingelheim Investigational Site | Chino | California | — | — |
| 1245.20.10009 Boehringer Ingelheim Investigational Site | Santa Ana | California | — | — |
| 1245.20.10131 Boehringer Ingelheim Investigational Site | West Hills | California | — | — |
| 1245.20.10038 Boehringer Ingelheim Investigational Site | Northglenn | Colorado | — | — |
| 1245.20.10137 Boehringer Ingelheim Investigational Site | Clearwater | Florida | — | — |
| 1245.20.10006 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1245.20.10085 Boehringer Ingelheim Investigational Site | Plantation | Florida | — | — |
| 1245.20.10078 Boehringer Ingelheim Investigational Site | Tampa | Florida | — | — |
| 1245.20.10080 Boehringer Ingelheim Investigational Site | Decatur | Georgia | — | — |
| 1245.20.10128 Boehringer Ingelheim Investigational Site | Avon | Indiana | — | — |
| 1245.20.10060 Boehringer Ingelheim Investigational Site | Fishers | Indiana | — | — |
| 1245.20.10065 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | — | — |
| 1245.20.10117 Boehringer Ingelheim Investigational Site | Arkansas City | Kansas | — | — |
| 1245.20.10039 Boehringer Ingelheim Investigational Site | Wichita | Kansas | — | — |
| 1245.20.10146 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | — | — |
| 1245.20.10144 Boehringer Ingelheim Investigational Site | Watertown | Massachusetts | — | — |
| 1245.20.10115 Boehringer Ingelheim Investigational Site | Brick | New Jersey | — | — |
| 1245.20.10129 Boehringer Ingelheim Investigational Site | Carlisle | Ohio | — | — |
| 1245.20.10045 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1245.20.10119 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1245.20.10130 Boehringer Ingelheim Investigational Site | Gallipolis | Ohio | — | — |
| 1245.20.10089 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1245.20.10151 Boehringer Ingelheim Investigational Site | Hurst | Texas | — | — |
| 1245.20.10155 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 97 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01177813, 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 Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01177813 live on ClinicalTrials.gov.