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Completed Phase 3 Interventional Results available

Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

ClinicalTrials.gov ID: NCT02414958

Public ClinicalTrials.gov record NCT02414958. 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 Sep 1, 2026, 2:56 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 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

Brief summary

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

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.

Study identification

NCT ID
NCT02414958
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
730 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
Jun 29, 2015
Primary completion
Apr 19, 2017
Completion
Oct 22, 2017
Last update posted
Jan 2, 2019

2015 – 2017

United States locations

U.S. sites
34
U.S. states
17
U.S. cities
34
Facility City State ZIP Site status
AMCR Institute, Inc. Escondido California 92025
Diabetes/Lipid Management and Research Center Huntington Beach California 92648
National Research Institute Los Angeles California 90057
Mills-Peninsula Health Services San Mateo California 94401
Metabolic Institute of America Tarzana California 91356
University Clinical Investigators, Inc. Tustin California 92780
Creekside Endocrine Associates, PC Denver Colorado 80246
The Center for Diabetes and Endocrine Care Fort Lauderdale Florida 33312
East Coast Institute for Research, LLC Jacksonville Florida 32204
Baptist Diabetes Associates, PA Miami Florida 33156
Physicians Research Associates, LLC Lawrenceville Georgia 30046
Endocrine Research Solutions, Inc. Roswell Georgia 30076
Rocky Mountain Diabetes and Osteoporosis Center Idaho Falls Idaho 83404
Northwest Endo Diabetes Research, LLC Arlington Heights Illinois 60005
Midwest Endocrinology Crystal Lake Illinois 60012
Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa 50265
Diabetes anddocrine Associates, PC Omaha Nebraska 68114
Desert Endocrinology Clinical Research Center Henderson Nevada 89052
Palm Research Center Las Vegas Nevada 89148
Southern New Hampshire Diabetes and Endocrinology Nashua New Hampshire 03063
Albany Medical Center / Albany Medical College Albany New York 12206
University Physicians Group Research Division Staten Island New York 10301
Diabetes and Endocrinology Consultants, PC Morehead City North Carolina 28557
The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital Cincinnati Ohio 45219
Diabetes and Obesity Clinical Trials Center Nashville Tennessee 37212
North Texas Endocrine Center Dallas Texas 75231
Office of Dr. Michelle Zaniewski-Singh Houston Texas 77090
Texas Diabetes and Endocrinology Round Rock Texas 78681
Bateman Horne Center Salt Lake City Utah 84102
Advanced Research Institute South Ogden Utah 84405
Larry D Stonesifer, MD Inc., PS Federal Way Washington 98003
Rainier Clinical Research Center, Inc Renton Washington 98057
The Polyclinic Seattle Washington 98104
MultiCare Institute for Research and Innovation Tacoma Washington 98405

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 97 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02414958, 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 Jan 2, 2019 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02414958 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →