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

Part of paid clinical trials in Escondido, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT02414958
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2015
Status verified
Dec 2018
Primary completion
Apr 20, 2017
Completion
Oct 23, 2017

Study Design

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

Arms

  • Experimental: Empagliflozin low dose
    Empagliflozin tablets once daily
  • Experimental: Empagliflozin high dose
    Empagliflozin tablets once daily
  • Placebo Comparator: Placebo
    Placebo tablets matching empagliflozin once daily

Primary Outcome Measure

Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline to week 26 ]

Locations (34)

FacilityCityStateZIPSite coordinators
AMCR Institute, Inc.EscondidoCalifornia92025-
Diabetes/Lipid Management and Research CenterHuntington BeachCalifornia92648-
National Research InstituteLos AngelesCalifornia90057-
Mills-Peninsula Health ServicesSan MateoCalifornia94401-
Metabolic Institute of AmericaTarzanaCalifornia91356-
University Clinical Investigators, Inc.TustinCalifornia92780-
Creekside Endocrine Associates, PCDenverColorado80246-
The Center for Diabetes and Endocrine CareFort LauderdaleFlorida33312-
East Coast Institute for Research, LLCJacksonvilleFlorida32204-
Baptist Diabetes Associates, PAMiamiFlorida33156-
Physicians Research Associates, LLCLawrencevilleGeorgia30046-
Endocrine Research Solutions, Inc.RoswellGeorgia30076-
Rocky Mountain Diabetes and Osteoporosis CenterIdaho FallsIdaho83404-
Northwest Endo Diabetes Research, LLCArlington HeightsIllinois60005-
Midwest EndocrinologyCrystal LakeIllinois60012-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
Diabetes anddocrine Associates, PCOmahaNebraska68114-
Desert Endocrinology Clinical Research CenterHendersonNevada89052-
Palm Research CenterLas VegasNevada89148-
Southern New Hampshire Diabetes and EndocrinologyNashuaNew Hampshire03063-
Albany Medical Center / Albany Medical CollegeAlbanyNew York12206-
University Physicians Group Research DivisionStaten IslandNew York10301-
Diabetes and Endocrinology Consultants, PCMorehead CityNorth Carolina28557-
The Carl and Edyth Lindner Center for Research & Education at The Christ HospitalCincinnatiOhio45219-
Diabetes and Obesity Clinical Trials CenterNashvilleTennessee37212-
North Texas Endocrine CenterDallasTexas75231-
Office of Dr. Michelle Zaniewski-SinghHoustonTexas77090-
Texas Diabetes and EndocrinologyRound RockTexas78681-
Bateman Horne CenterSalt Lake CityUtah84102-
Advanced Research InstituteSouth OgdenUtah84405-
Larry D Stonesifer, MD Inc., PSFederal WayWashington98003-
Rainier Clinical Research Center, IncRentonWashington98057-
The PolyclinicSeattleWashington98104-
MultiCare Institute for Research and InnovationTacomaWashington98405-

Find similar trials in Escondido, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
AMCR Institute, Inc.· Escondido, CADiabetes/Lipid Management and Research Center· Huntington Beach, CANational Research Institute· Los Angeles, CAMills-Peninsula Health Services· San Mateo, CAMetabolic Institute of America· Tarzana, CAUniversity Clinical Investigators, Inc.· Tustin, CA

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