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

Part of paid clinical trials in Montgomery, Alabama.

Sponsor
Boehringer Ingelheim
Study ID
NCT02580591
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Dec 22, 2015
Status verified
Oct 2018
Primary completion
Sep 12, 2017
Completion
Sep 20, 2017

Study Design

Enrollment
977 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin low dose
  • Experimental: Empagliflozin high dose
  • Experimental: Empagliflozin medium dose
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) [ Time Frame: Baseline to week 26 ]

Locations (39)

FacilityCityStateZIPSite coordinators
Healthscan Clinical Trials LLCMontgomeryAlabama36106-
John Muir Physician Network Clinical Research CenterConcordCalifornia94520-
Valley ResearchFresnoCalifornia93720-
Marin Endocrine Care and ResearchGreenbraeCalifornia94904-
Pacific Research Partners, LLCOaklandCalifornia94607-
NorCal Endocrinology and Internal MedicineSan RamonCalifornia94583-
William Sansum Diabetes CenterSanta BarbaraCalifornia93105-
University of Colorado DenverAuroraColorado80045-
International Research Associates, LLCHialeahFlorida33012-
Solutions Through Advanced Research, Inc.JacksonvilleFlorida32225-
University of MiamiMiamiFlorida33136-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
Physicians Research Associates, LLCLawrencevilleGeorgia30046-
Sestron Clinical ResearchMariettaGeorgia30060-
Eagle's Landing Diabetes and EndocrinologyStockbridgeGeorgia30281-
Northwest Endo Diabetes Research, LLCArlington HeightsIllinois60005-
Kentucky Diabetes Endocrinology CenterLexingtonKentucky40503-
MODEL Clinical ResearchBaltimoreMaryland21204-
University of Maryland School of MedicineBaltimoreMaryland21201-
Clinical Research Consultants, LLCKansas CityMissouri64111-
Desert Endocrinology Clinical Research CenterHendersonNevada89052-
Palm Research CenterLas VegasNevada89128-
Endocrine-Diabetes Care and Resource CenterRochesterNew York14607-
Endocrine Associates of Long Island, PCSmithtownNew York11787-
Diabetes Endocrinology Research Center of Western New YorkWilliamsvilleNew York14221-
Diabetes and Endocrinology Consultants, PCMorehead CityNorth Carolina28557-
Holzer Clinic LLCGallipolisOhio45631-
COR Clinical Research, LLCOklahoma CityOklahoma73103-
Strand Physician Specialists dba Carolina Health SpecialistsMyrtle BeachSouth Carolina29572-
AM Diabetes and Endocrinology CenterBartlettTennessee38133-
Holston Medical GroupBristolTennessee37620-
University Diabetes and Endocrine ConsultantsChattanoogaTennessee37411-
Texas Diabetes & Endocrinology PAAustinTexas78749-
Dallas Diabetes and Endocrine CenterDallasTexas75230-
Research Institute of DallasDallasTexas75231-
Texas Health Physicians GroupDallasTexas75218-
Endeavor Clinical Trials, PASan AntonioTexas78229-
Virginia Endocrinology ResearchChesapeakeVirginia23321-

Find similar trials in Montgomery, AL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Healthscan Clinical Trials LLC· Montgomery, ALJohn Muir Physician Network Clinical Research Center· Concord, CAValley Research· Fresno, CAMarin Endocrine Care and Research· Greenbrae, CAPacific Research Partners, LLC· Oakland, CANorCal Endocrinology and Internal Medicine· San Ramon, CA

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