A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

Part of paid clinical trials in Concord, California.

Sponsor
Eli Lilly and Company
Study ID
NCT05463744
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Insulin Efsitora Alfa — DRUG
    Administered SC
  • Insulin Degludec — DRUG
    Administered SC

Study Details

The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Key Dates

Start date
Aug 12, 2022
Status verified
Jun 2025
Primary completion
May 7, 2024
Completion
May 7, 2024

Study Design

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

Arms

  • Experimental: Insulin Efsitora Alfa
    Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 units per milliliter (U/mL) Insulin Lispro) received 500 U/mL of insulin efsitora alfa administered once weekly (QW) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.
  • Active Comparator: Insulin Degludec
    Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 U/mL Insulin Lispro) received 100 U/mL of Insulin Degludec administered once daily (QD) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis] [ Time Frame: Baseline, Week 26 ]

Locations (34)

FacilityCityStateZIPSite coordinators
John Muir Physician Network Research CenterConcordCalifornia94520-
Valley ResearchFresnoCalifornia93720-
Catalina Research Institute, LLCMontclairCalifornia91763-
Sansum Diabetes Research InstituteSanta BarbaraCalifornia93105-
University Clinical Investigators, Inc.TustinCalifornia92780-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Northeast Research Institute (NERI)Fleming IslandFlorida32003-
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine CareFort LauderdaleFlorida33312-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
Hanson Clinical Research CenterPort CharlotteFlorida33952-
East Coast Institute for Research at The Jones CenterMaconGeorgia31210-
East-West Medical Research InstituteHonoluluHawaii96814-
Rocky Mountain Clinical ResearchIdaho FallsIdaho83404-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
Cotton O'Neil Clinical Research CenterTopekaKansas66606-
MedStar Health Research Institute (MedStar Physician Based Research Network)HyattsvilleMaryland20782-
Endocrine and Metabolic ConsultantsRockvilleMaryland20852-
Clinvest Research LLCSpringfieldMissouri65807-
Palm Research Center SunsetLas VegasNevada89148-
Palm Research Center TenayaLas VegasNevada89128-
Research Foundation of SUNY - University of BuffaloBuffaloNew York14221-
NYU Langone Hospital - Long IslandMineolaNew York11501-
NYC ResearchNew YorkNew York10016-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Texas Diabetes & Endocrinology, P.A.AustinTexas78731-
Dallas Diabetes Research CenterDallasTexas75230-
North Texas Endocrine CenterDallasTexas75231-
Research Institute of DallasDallasTexas75231-
Amir A Hassan, MD, PAHoustonTexas77089-
Biopharma Informatic, LLCHoustonTexas77043-
Southern Endocrinology AssociatesMesquiteTexas75149-
Texas Diabetes & Endocrinology, P.A.Round RockTexas78681-
Rainier Clinical Research CenterRentonWashington98057-

Related coverage on Hipa.ai

Find similar trials in Concord, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
John Muir Physician Network Research Center· Concord, CAValley Research· Fresno, CACatalina Research Institute, LLC· Montclair, CASansum Diabetes Research Institute· Santa Barbara, CAUniversity Clinical Investigators, Inc.· Tustin, CAUniversity of Colorado Anschutz Medical Campus· Aurora, CO

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