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Completed Phase 3 Interventional Results available

Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)

ClinicalTrials.gov ID: NCT02580591

Public ClinicalTrials.gov record NCT02580591. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 16, 2026, 5:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-3)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT02580591
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
977 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 22, 2015 (Actual)
Primary completion
Sep 12, 2017 (Actual)
Completion
Sep 20, 2017 (Actual)
Last update posted
Nov 2, 2018

2015 – 2017

United States locations

U.S. sites
39
U.S. states
18
U.S. cities
36
Facility City State ZIP Site status
Healthscan Clinical Trials LLC Montgomery Alabama 36106 —
John Muir Physician Network Clinical Research Center Concord California 94520 —
Valley Research Fresno California 93720 —
Marin Endocrine Care and Research Greenbrae California 94904 —
Pacific Research Partners, LLC Oakland California 94607 —
NorCal Endocrinology and Internal Medicine San Ramon California 94583 —
William Sansum Diabetes Center Santa Barbara California 93105 —
University of Colorado Denver Aurora Colorado 80045 —
International Research Associates, LLC Hialeah Florida 33012 —
Solutions Through Advanced Research, Inc. Jacksonville Florida 32225 —
University of Miami Miami Florida 33136 —
Suncoast Clinical Research, Inc. New Port Richey Florida 34652 —
Atlanta Diabetes Associates Atlanta Georgia 30318 —
Physicians Research Associates, LLC Lawrenceville Georgia 30046 —
Sestron Clinical Research Marietta Georgia 30060 —
Eagle's Landing Diabetes and Endocrinology Stockbridge Georgia 30281 —
Northwest Endo Diabetes Research, LLC Arlington Heights Illinois 60005 —
Kentucky Diabetes Endocrinology Center Lexington Kentucky 40503 —
University of Maryland School of Medicine Baltimore Maryland 21201 —
MODEL Clinical Research Baltimore Maryland 21204 —
Clinical Research Consultants, LLC Kansas City Missouri 64111 —
Desert Endocrinology Clinical Research Center Henderson Nevada 89052 —
Palm Research Center Las Vegas Nevada 89128 —
Endocrine-Diabetes Care and Resource Center Rochester New York 14607 —
Endocrine Associates of Long Island, PC Smithtown New York 11787 —
Diabetes Endocrinology Research Center of Western New York Williamsville New York 14221 —
Diabetes and Endocrinology Consultants, PC Morehead City North Carolina 28557 —
Holzer Clinic LLC Gallipolis Ohio 45631 —
COR Clinical Research, LLC Oklahoma City Oklahoma 73103 —
Strand Physician Specialists dba Carolina Health Specialists Myrtle Beach South Carolina 29572 —
AM Diabetes and Endocrinology Center Bartlett Tennessee 38133 —
Holston Medical Group Bristol Tennessee 37620 —
University Diabetes and Endocrine Consultants Chattanooga Tennessee 37411 —
Texas Diabetes & Endocrinology PA Austin Texas 78749 —
Texas Health Physicians Group Dallas Texas 75218 —
Dallas Diabetes and Endocrine Center Dallas Texas 75230 —
Research Institute of Dallas Dallas Texas 75231 —
Endeavor Clinical Trials, PA San Antonio Texas 78229 —
Virginia Endocrinology Research Chesapeake Virginia 23321 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 150 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02580591, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 2, 2018 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02580591 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →