A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
Public ClinicalTrials.gov record NCT01649297. 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 Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
Study identification
- NCT ID
- NCT01649297
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 983 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- empagliflozin (low dose qd) Drug
- Empagliflozin (high dose qd) Drug
- empagliflozin (high dose bid) Drug
- empagliflozin (low dose bid) 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
- Oct 2012 (Type not available)
- Primary completion
- Dec 2013 (Actual)
- Completion
- Dec 2013 (Actual)
- Last update posted
- Jul 23, 2015
2012 – 2013
United States locations
- U.S. sites
- 39
- U.S. states
- 19
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1276.10.11036 Boehringer Ingelheim Investigational Site | Florence | Alabama | — | — |
| 1276.10.11049 Boehringer Ingelheim Investigational Site | Jonesboro | Arkansas | — | — |
| 1276.10.11040 Boehringer Ingelheim Investigational Site | Lomita | California | — | — |
| 1276.10.11033 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1276.10.11002 Boehringer Ingelheim Investigational Site | Rancho Cucamonga | California | — | — |
| 1276.10.11050 Boehringer Ingelheim Investigational Site | Sacramento | California | — | — |
| 1276.10.11015 Boehringer Ingelheim Investigational Site | West Hills | California | — | — |
| 1276.10.11012 Boehringer Ingelheim Investigational Site | Norwalk | Connecticut | — | — |
| 1276.10.11047 Boehringer Ingelheim Investigational Site | Waterbury | Connecticut | — | — |
| 1276.10.11010 Boehringer Ingelheim Investigational Site | Bradenton | Florida | — | — |
| 1276.10.11005 Boehringer Ingelheim Investigational Site | Davie | Florida | — | — |
| 1276.10.11004 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | — | — |
| 1276.10.11051 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1276.10.11009 Boehringer Ingelheim Investigational Site | Oakland Park | Florida | — | — |
| 1276.10.11044 Boehringer Ingelheim Investigational Site | Palm Harbor | Florida | — | — |
| 1276.10.11030 Boehringer Ingelheim Investigational Site | Dunwoody | Georgia | — | — |
| 1276.10.11027 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1276.10.11020 Boehringer Ingelheim Investigational Site | Elwood | Indiana | — | — |
| 1276.10.11001 Boehringer Ingelheim Investigational Site | Bangor | Maine | — | — |
| 1276.10.11048 Boehringer Ingelheim Investigational Site | Sterling Heights | Michigan | — | — |
| 1276.10.11058 Boehringer Ingelheim Investigational Site | Jackson | Mississippi | — | — |
| 1276.10.11055 Boehringer Ingelheim Investigational Site | Edison | New Jersey | — | — |
| 1276.10.11011 Boehringer Ingelheim Investigational Site | Brooklyn | New York | — | — |
| 1276.10.11035 Boehringer Ingelheim Investigational Site | North Myrtle Beach | North Carolina | — | — |
| 1276.10.11041 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | — | — |
| 1276.10.11018 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1276.10.11043 Boehringer Ingelheim Investigational Site | Dayton | Ohio | — | — |
| 1276.10.11017 Boehringer Ingelheim Investigational Site | Kettering | Ohio | — | — |
| 1276.10.11022 Boehringer Ingelheim Investigational Site | Fleetwood | Pennsylvania | — | — |
| 1276.10.11003 Boehringer Ingelheim Investigational Site | Johnson City | Tennessee | — | — |
| 1276.10.11042 Boehringer Ingelheim Investigational Site | Corpus Christi | Texas | — | — |
| 1276.10.11013 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1276.10.11026 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1276.10.11031 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1276.10.11034 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1276.10.11028 Boehringer Ingelheim Investigational Site | Pearland | Texas | — | — |
| 1276.10.11029 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1276.10.11016 Boehringer Ingelheim Investigational Site | Port Orchard | Washington | — | — |
| 1276.10.11024 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 100 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01649297, 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 Jul 23, 2015 · 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 NCT01649297 live on ClinicalTrials.gov.