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

NCT02414958 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2019-01-03

Study results available
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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

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Empagliflozin

DRUG

Empagliflozin

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-04-20
Completion
2017-10-23

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02414958 on ClinicalTrials.gov