Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
Public ClinicalTrials.gov record NCT01778049. 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, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
Study identification
- NCT ID
- NCT01778049
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 708 participants
Conditions and interventions
Conditions
Interventions
- BI 10773 Drug
- BI 10773 Placebo Drug
- BI 10773 / BI 1356 Drug
- BI 10773 / BI 1356 Placebo 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
- Jan 2013 (Type not available)
- Primary completion
- Mar 2015 (Actual)
- Completion
- Mar 2015 (Actual)
- Last update posted
- Apr 4, 2016
2013 – 2015
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1275.10.01019 Boehringer Ingelheim Investigational Site | Chino | California | — | — |
| 1275.10.01008 Boehringer Ingelheim Investigational Site | Huntington Beach | California | — | — |
| 1275.10.01003 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 1275.10.01024 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 1275.10.01002 Boehringer Ingelheim Investigational Site | Sylmar | California | — | — |
| 1275.10.01011 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1275.10.01009 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 1275.10.01023 Boehringer Ingelheim Investigational Site | Oviedo | Florida | — | — |
| 1275.10.01006 Boehringer Ingelheim Investigational Site | Tamarac | Florida | — | — |
| 1275.10.01017 Boehringer Ingelheim Investigational Site | Conyers | Georgia | — | — |
| 1275.10.01016 Boehringer Ingelheim Investigational Site | Snellville | Georgia | — | — |
| 1275.10.01012 Boehringer Ingelheim Investigational Site | Avon | Indiana | — | — |
| 1275.10.01013 Boehringer Ingelheim Investigational Site | Muncie | Indiana | — | — |
| 1275.10.01010 Boehringer Ingelheim Investigational Site | Elkton | Maryland | — | — |
| 1275.10.01001 Boehringer Ingelheim Investigational Site | Stevensville | Michigan | — | — |
| 1275.10.01007 Boehringer Ingelheim Investigational Site | Salisbury | North Carolina | — | — |
| 1275.10.01005 Boehringer Ingelheim Investigational Site | Bismarck | North Dakota | — | — |
| 1275.10.01020 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 1275.10.01022 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1275.10.01021 Boehringer Ingelheim Investigational Site | Union | South Carolina | — | — |
| 1275.10.01014 Boehringer Ingelheim Investigational Site | North Richland Hills | Texas | — | — |
| 1275.10.01018 Boehringer Ingelheim Investigational Site | Draper | Utah | — | — |
| 1275.10.01015 Boehringer Ingelheim Investigational Site | Richmond | Virginia | — | — |
| 1275.10.01025 Boehringer Ingelheim Investigational Site | Virginia Beach | Virginia | — | — |
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 90 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01778049, 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 Apr 4, 2016 · 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 NCT01778049 live on ClinicalTrials.gov.