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NCT01778049 · ClinicalTrials.gov registry record · Phase 3
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 708
- Enrollment target
NCT01778049: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01778049 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 708 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01778049, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 708 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference. Observed Case (OC): This method
Interventions
- DRUG BI 10773
- DRUG BI 10773 Placebo
- DRUG BI 10773 / BI 1356
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 708 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01778049 record still lists
NCT01778049 is an interventional study that assigns participants to a tested intervention. The registered 708 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which BI 10773 is the first listed.
NCT01778049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01778049 about?
NCT01778049 is a clinical study titled "Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes". 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 evaluat...
What is the current status of trial NCT01778049?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 708 participants. The study started on 2013-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01778049?
The interventions under investigation include: BI 10773 (DRUG), BI 10773 Placebo (DRUG), BI 10773 / BI 1356 (DRUG).
Who is sponsoring clinical trial NCT01778049?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01778049's enrollment target sits among peer trials
708 505th of 2000 higher than 1,496 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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