Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Boehringer Ingelheim.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline in glycated haemoglobin (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 randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treat
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 |
What the finished NCT02414958 record still lists
NCT02414958 is an interventional study that assigns participants to a tested intervention. The registered 730 participants enrollment target is mid-sized for trials with a published cap, below the 1,260-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (42% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02414958's enrollment target sits among peer trials
730 9th of 118 higher than 110 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 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
-
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
RECRUITING · Phase 3
-
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
RECRUITING · Phase 3
-
A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
RECRUITING · Phase 3
-
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
RECRUITING · Phase 3
-
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
RECRUITING · Phase 3
-
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03232918 · 730 participants · Phase 4
Oxytocin and Fetal Heart Rate Changes
- NCT05548283 · 730 participants · Phase 4
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
- NCT07312162 · 730 participants
Multilevel Determinants of Socioeconomic Disparities in Geographic Late-Stage Hepatocellular Carcinoma Hotspots
- NCT05065216 · 728 participants · Phase 2
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI