A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Eli Lilly and Company
Study ID
NCT05275400
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 reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Key Dates

Start date
Mar 8, 2022
Status verified
May 2025
Primary completion
May 15, 2024
Completion
May 15, 2024

Study Design

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

Arms

  • Experimental: 500 U/mL - Insulin Efsitora
    Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).
  • Active Comparator: 100 U/mL - Insulin Degludec
    Participants received 100 U/mL insulin degludec administered SC once daily (QD).

Primary Outcome Measure

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

Locations (38)

FacilityCityStateZIPSite coordinators
Medical InvestigationsLittle RockArkansas72211-
John Muir Physician Network Research CenterConcordCalifornia94520-
AMCR InstituteEscondidoCalifornia92025-
National Research Institute - Huntington ParkHuntington ParkCalifornia90255-
Scripps Whittier Diabetes InstituteLa JollaCalifornia92037-
Diabetes Associates Medical GroupOrangeCalifornia92868-
University Clinical Investigators, Inc.TustinCalifornia92780-
Chase Medical Research, LLCWaterburyConnecticut06708-
Encore Medical ResearchHollywoodFlorida33021-
New Horizon Research CenterMiamiFlorida33165-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
West Orange EndocrinologyOcoeeFlorida34761-
Balanced Life Health Care Solutions/SKYCRNGLawrencevilleGeorgia30046-
Rocky Mountain Clinical ResearchIdaho FallsIdaho83404-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
L-MARC Research CenterLouisvilleKentucky40213-
Endocrine and Metabolic ConsultantsRockvilleMaryland20852-
Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroyMichigan48098-
HealthPartners Institute dba International Diabetes CenterMinneapolisMinnesota55416-
SKY Clinical Research Network Group - HallFayetteMississippi39069-
Clinvest Research LLCSpringfieldMissouri65807-
Palm Research Center TenayaLas VegasNevada89128-
Albany Medical College, Division of Community EndocrinologyAlbanyNew York12203-
NYC ResearchNew YorkNew York10016-
Lillestol ResearchFargoNorth Dakota58104-
Aventiv Research IncColumbusOhio43213-
Intend Research, LLCNormanOklahoma73069-
Heritage Valley Medical Group, Inc.BeaverPennsylvania15009-
Jefferson Clinical Research Institute (JCRI)PhiladelphiaPennsylvania19114-
Preferred Primary Care PhysiciansUniontownPennsylvania15401-
Gadolin ResearchBeaumontTexas77702-
Dallas Diabetes Research CenterDallasTexas75230-
Biopharma Informatic, LLCHoustonTexas77043-
Juno ResearchHoustonTexas77040-
Southern Endocrinology AssociatesMesquiteTexas75149-
Texas Diabetes & Endocrinology, P.A.Round RockTexas78681-
Consano Clinical Research, LLCShavano ParkTexas78231-
Rainier Clinical Research CenterRentonWashington98057-

Related coverage on Hipa.ai

Find similar trials in Little Rock, AR

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Medical Investigations· Little Rock, ARJohn Muir Physician Network Research Center· Concord, CAAMCR Institute· Escondido, CANational Research Institute - Huntington Park· Huntington Park, CAScripps Whittier Diabetes Institute· La Jolla, CADiabetes Associates Medical Group· Orange, CA

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