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NCT02414958 · ClinicalTrials.gov registry record · Phase 3
Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
A Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 730
- Enrollment target
- 20
- Study locations
NCT02414958 is a Phase 3 study of Diabetes Mellitus, Type 1 that has completed, run by Boehringer Ingelheim. The registered enrollment target is 730 participants, below the 1,260-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT02414958, a Phase 3 study of Diabetes Mellitus, Type 1, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 730 participants
- Enrollment target
- 20
- Study locations
Study Summary
Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Empagliflozin
Study Locations (20)
California
- AMCR Institute, Inc. - Escondido
- Diabetes/Lipid Management and Research Center - Huntington Beach
- National Research Institute - Los Angeles
- Mills-Peninsula Health Services - San Mateo
- Metabolic Institute of America - Tarzana
- University Clinical Investigators, Inc. - Tustin
Florida
- The Center for Diabetes and Endocrine Care - Fort Lauderdale
- East Coast Institute for Research, LLC - Jacksonville
- Baptist Diabetes Associates, PA - Miami
Georgia
- Physicians Research Associates, LLC - Lawrenceville
- Endocrine Research Solutions, Inc. - Roswell
Illinois
- Northwest Endo Diabetes Research, LLC - Arlington Heights
- Midwest Endocrinology - Crystal Lake
Nevada
- Desert Endocrinology Clinical Research Center - Henderson
- Palm Research Center - Las Vegas
Colorado
- Creekside Endocrine Associates, PC - Denver
Idaho
- Rocky Mountain Diabetes and Osteoporosis Center - Idaho Falls
Iowa
- Iowa Diabetes and Endocrinology Research Center - West Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2015-06-30 |
| Est. Completion | 2017-10-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02414958
The ClinicalTrials.gov registry entry for NCT02414958 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 730 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,260-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (42% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02414958 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02414958 about?
NCT02414958 is a clinical study titled "Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)". Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and ...
What is the current status of trial NCT02414958?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 730 participants. The study started on 2015-06-30. Estimated completion is 2017-10-23.
What conditions does trial NCT02414958 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT02414958?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT02414958?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02414958 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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