Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
NCT02414958 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 730 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02414958 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02414958?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02414958?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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