A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

Part of paid clinical trials in Cullman, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT07076199
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Insulin icodec — DRUG
    Insulin icodec will be administered as subcutaneous injection
  • Insulin glargine — DRUG
    Insulin glargine will be administered as subcutaneous injection.
  • Insulin aspart — DRUG
    Insulin aspart will be administered as a subcutaneous injection.

Study Details

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Key Dates

Start date
Aug 11, 2025
Status verified
Jun 2026
Primary completion
Jan 25, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
877 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin icodec + insulin aspart
    Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
  • Active Comparator: Insulin glargine+ insulin aspart
    Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.

Primary Outcome Measure

Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 26 ]

Central Contacts

Locations (109)

FacilityCityStateZIPSite coordinators
Cullman Clinical TrialsCullmanAlabama35055-
John Muir HealthConcordCalifornia94520-
Headlands Research California, LLCEscondidoCalifornia92025-
Clinical Res of Central CaFresnoCalifornia93704-
Providence Medical FoundationFullertonCalifornia92835-
Scripps Whittier Diabetes InstLa JollaCalifornia92037-
Loma Linda University Faculty Medical ClinicsLoma LindaCalifornia92354-
Loma Linda University Faculty Medical ClinicsLoma LindaCalifornia92354-
Pacific Clinical StudiesLos AlamitosCalifornia90720-
Los Angeles Institute for Metabolic ResearchLos AngelesCalifornia90015-
Pasadena Clinical TrialsPasadenaCalifornia91101-
WestenU HealthPomonaCalifornia91766-
WestenU HealthPomonaCalifornia91766-
Alliance Clinical NetworkSan DiegoCalifornia92120-
Mills Health CenterSan MateoCalifornia94401-
Center for Endocrine DM and Metabolic DisordersSanta ClaritaCalifornia91321-
University Clin InvestigatorsTustinCalifornia92780-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Denver Endocrinology Diabetes and Thyroid CenterEnglewoodColorado80113-
Denver Endocrinology Diabetes and Thyroid CenterEnglewoodColorado80113-
Optumcare Clinical Trials,LLC-GoldenGoldenColorado80401-
Northeast Research InstituteFleming IslandFlorida32003-
Encore Medical Research LLCHollywoodFlorida33024-
Northeast Research InstituteJacksonvilleFlorida32204-
Life Spring Research Foundation LLCMiamiFlorida33130-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
West Orange EndocrinologyOcoeeFlorida34761-
Suncoast Clinical Research, Inc.Palm HarborFlorida34684-
Center for Diab,Obes & MetabPembroke PinesFlorida33024-
SRA Trials-BrowardPembroke PinesFlorida33024-
Hanson Clinical Research CenterPort CharlotteFlorida33952-
Latin Clinical Trial CtrTamaracFlorida33321-
Bayside Clinical ResearchTampaFlorida33607-
Metabolic Research Institute IncWest Palm BeachFlorida33401-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
Centricity Research ColumbusColumbusGeorgia31904-
Physicians Research Assoc. LLCLawrencevilleGeorgia30046-
Endocrine Research Solutions, IncRoswellGeorgia30076-
Rocky Mt Clin Res, LLCIdaho FallsIdaho83404-7596-
Northwestern UniversityChicagoIllinois60611-
University Of ChicagoChicagoIllinois60637-1447-
Endeavor HealthSkokieIllinois60077-
Indiana Uni School of Med-PedIndianapolisIndiana46202-5209-
Iowa Diabetes ResearchWest Des MoinesIowa50266-
Cotton O'Neil Diabetes & EndocrinologyTopekaKansas66606-
Robley Rex VA Medical CenterLouisvilleKentucky40206-
MedStar Health Research InstituteOlneyMaryland20832-
Brigham & Women's HospitalBostonMassachusetts02115-5804-
Profound Research LLCClarkstonMichigan48346-
Profound Research LLCFarmington HillsMichigan48334-
Elite Clinical Research CenterFlintMichigan48532-
International Diabetes CenterMinneapolisMinnesota55416-
Mayo ClinicRochesterMinnesota55905-
Saint Louis UniversitySt LouisMissouri63103-
Saint Louis UniversitySt LouisMissouri63103-
Washington UniversitySt LouisMissouri63110-
Washington UniversitySt LouisMissouri63110-
QCR NetworkOmahaNebraska68114-
University of Nebraska Medical CenterOmahaNebraska68198-
Palm Research Center Inc.Las VegasNevada89148-
Albuquerque Clinical Trials Inc.AlbuquerqueNew Mexico87102-
AMC Community EndocrinologyAlbanyNew York12203-
NYC Research, Inc.New YorkNew York10016-
NYU Langone Orthopedic CenterNew YorkNew York10016-
University at BuffaloWilliamsvilleNew York14221-
Physicians East EndocrinologyGreenvilleNorth Carolina27834-
Centricity Rsrch MHCity MultiMorehead CityNorth Carolina28557-
Centricity Res New Bern MultispecialityNew BernNorth Carolina28562-
Accellacare of RaleighRaleighNorth Carolina27609-
Accellacare WilmingtonWilmingtonNorth Carolina28401-
Diab & Endo Assoc of Stark CoCantonOhio44718-
Cleveland Clinic_ClevelandClevelandOhio44195-
The Ohio State University Medical CenterColumbusOhio43203-
Alliance for Multispecialty ResearchNormanOklahoma73069-
Lynn Institute of NormanNormanOklahoma73069-
Lynn Institute - East OKCOklahoma CityOklahoma73111-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Prisma Health Endo Spc Thy CtrGreenvilleSouth Carolina29605-
Holston Medical Group_BristolBristolTennessee37620-
University Diabetes & Endocrine ConsultantsChattanoogaTennessee37411-
MidState Endocrine AssociatesNashvilleTennessee37203-
Vanderbilt Medical Center_NashvilleNashvilleTennessee37212-
Amarillo Medical SpecialistsAmarilloTexas79124-
Texas Diab Endo ATX N Mopac EXPRAustinTexas78731-
Texas Diabetes & EndocrinologyAustinTexas78749-
Alliance Clinical NetworkDallasTexas75203-
North Texas Endocrine CenterDallasTexas75231-
Research Institute Of DallasDallasTexas75231-
Thyroid Endocrinology & Diabetes PADallasTexas75208-
Velocity Clinical Res-DallasDallasTexas75230-
Precision Endo - RevivalDentonTexas76210-
Epic Medical ResearchDeSotoTexas75115-
Frontier Medical CtrEl PasoTexas79935-
N. Texas Diab & Endo - PrimeFlower MoundTexas75028-
N. Texas Diab & Endo - PrimeFlower MoundTexas75028-
Diabetes and Thyroid Center of Fort WorthFort WorthTexas76132-
Amir Ali Hassan, MD, PAHoustonTexas77089-
Houston Endocrinology CenterHoustonTexas77040-
The Endocrine CenterHoustonTexas77079-
RGV Endocrine CenterMcAllenTexas78503-
Tekton ResearchMcKinneyTexas75069-
Be Well Clinical StudiesRound RockTexas78681-
Texas Diabetes & Endocrinology_Round RockRound RockTexas78681-
Northeast Clinical Research of San AntonioSan AntonioTexas78233-
Valley Diab. & Endo Comp CtrWeslacoTexas78596-
Rio Clinical TrialsOgdenUtah84404-
UVM EndocrinologySouth BurlingtonVermont05403-
Rainier Clin Res Ctr IncRentonWashington98057-
Prevea HealthGreen BayWisconsin54303-

Find similar trials in Cullman, AL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Cullman Clinical Trials· Cullman, ALJohn Muir Health· Concord, CAHeadlands Research California, LLC· Escondido, CAClinical Res of Central Ca· Fresno, CAProvidence Medical Foundation· Fullerton, CAScripps Whittier Diabetes Inst· La Jolla, CA

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