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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 708 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01778049
The ClinicalTrials.gov registry entry for NCT01778049 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 708 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which BI 10773 is the first listed.
NCT01778049 reports 0 study locations.
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.
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