Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
Public ClinicalTrials.gov record NCT01719003. 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 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus
Study identification
- NCT ID
- NCT01719003
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Boehringer Ingelheim
- Industry
- Enrollment
- 1,413 participants
Conditions and interventions
Conditions
Interventions
- Metformin 500 mg bid Drug
- Metformin 1000 mg bid Drug
- Empagliflozin low dose qd Drug
- Empagliflozin high dose qd Drug
- Empagliflozin low dose bid Drug
- Empagliflozin high 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
- Sep 30, 2012
- Primary completion
- Oct 31, 2014
- Completion
- Nov 30, 2014
- Last update posted
- Feb 18, 2016
2012 – 2014
United States locations
- U.S. sites
- 41
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1276.1.10014 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1276.1.10019 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1276.1.10044 Boehringer Ingelheim Investigational Site | Manley Hot Springs | Alaska | — | — |
| 1276.1.10010 Boehringer Ingelheim Investigational Site | Glendale | Arizona | — | — |
| 1276.1.10035 Boehringer Ingelheim Investigational Site | Searcy | Arkansas | — | — |
| 1276.1.10046 Boehringer Ingelheim Investigational Site | Chula Vista | California | — | — |
| 1276.1.10006 Boehringer Ingelheim Investigational Site | Huntington Beach | California | — | — |
| 1276.1.10043 Boehringer Ingelheim Investigational Site | La Mesa | California | — | — |
| 1276.1.10009 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1276.1.10040 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1276.1.10045 Boehringer Ingelheim Investigational Site | Oceanside | California | — | — |
| 1276.1.10042 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | — | — |
| 1276.1.10001 Boehringer Ingelheim Investigational Site | Denver | Colorado | — | — |
| 1276.1.10003 Boehringer Ingelheim Investigational Site | Northglenn | Colorado | — | — |
| 1276.1.10026 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | — | — |
| 1276.1.10024 Boehringer Ingelheim Investigational Site | Oldsmar | Florida | — | — |
| 1276.1.10027 Boehringer Ingelheim Investigational Site | Port Orange | Florida | — | — |
| 1276.1.10023 Boehringer Ingelheim Investigational Site | Marietta | Georgia | — | — |
| 1276.1.10034 Boehringer Ingelheim Investigational Site | Evansville | Indiana | — | — |
| 1276.1.10032 Boehringer Ingelheim Investigational Site | Fall River | Massachusetts | — | — |
| 1276.1.10036 Boehringer Ingelheim Investigational Site | Bridgman | Michigan | — | — |
| 1276.1.10037 Boehringer Ingelheim Investigational Site | Hazelwood | Missouri | — | — |
| 1276.1.10007 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | — | — |
| 1276.1.10015 Boehringer Ingelheim Investigational Site | Union | New Jersey | — | — |
| 1276.1.10033 Boehringer Ingelheim Investigational Site | Asheboro | North Carolina | — | — |
| 1276.1.10022 Boehringer Ingelheim Investigational Site | Burlington | North Carolina | — | — |
| 1276.1.10002 Boehringer Ingelheim Investigational Site | Lenoir | North Carolina | — | — |
| 1276.1.10005 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1276.1.10011 Boehringer Ingelheim Investigational Site | Gallipolis | Ohio | — | — |
| 1276.1.10030 Boehringer Ingelheim Investigational Site | Columbia | South Carolina | — | — |
| 1276.1.10008 Boehringer Ingelheim Investigational Site | Greer | South Carolina | — | — |
| 1276.1.10013 Boehringer Ingelheim Investigational Site | Hodges | South Carolina | — | — |
| 1276.1.10017 Boehringer Ingelheim Investigational Site | Humboldt | Tennessee | — | — |
| 1276.1.10018 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1276.1.10025 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1276.1.10028 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1276.1.10016 Boehringer Ingelheim Investigational Site | Kingwood | Texas | — | — |
| 1276.1.10021 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1276.1.10041 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1276.1.10004 Boehringer Ingelheim Investigational Site | Manassas | Virginia | — | — |
| 1276.1.10012 Boehringer Ingelheim Investigational Site | Wenatchee | 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 149 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01719003, 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 Feb 18, 2016 · Synced Jun 28, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01719003 live on ClinicalTrials.gov.