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NCT02580591 · ClinicalTrials.gov registry record · Phase 3
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 977
- Enrollment target
NCT02580591: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT02580591 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 977 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02580591, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 977 participants
- Enrollment target
Study Summary
The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
Primary Outcome
Change from baseline in Glycated hemoglobin (HbA1c) for full analysis set (FAS) (observed cases \[OC\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.
Interventions
- DRUG Placebo
- DRUG Empagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 977 participants |
| Start Date | 2015-12-22 |
| Est. Completion | 2017-09-20 |
| Phase | Phase 3 |
What the finished NCT02580591 record still lists
NCT02580591 is an interventional study that assigns participants to a tested intervention. The registered 977 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02580591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02580591 about?
NCT02580591 is a clinical study titled "Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)". The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
What is the current status of trial NCT02580591?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 977 participants. The study started on 2015-12-22. Estimated completion is 2017-09-20.
What interventions are being tested in trial NCT02580591?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT02580591?
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 NCT02580591's enrollment target sits among peer trials
977 325th of 2000 higher than 1,676 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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