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

NCT07076199 — Phase 3, Active not recruiting, 877 participants, Novo Nordisk A/S

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A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

RegistryNCT07076199, acronym ONWARDS 11
StatusActive not recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment877 (Estimated)
SponsorNovo Nordisk A/S (Industry)
ConditionsDiabetes Mellitus, Type 1
InterventionsInsulin icodec, Insulin glargine, Insulin aspart (Drug)
Datesstart 2025-08-11, primary completion 2027-01-25 (estimated), completion 2027-03-01 (estimated), first posted 2025-07-22, last updated 2026-09-25
Locations182 sites in United States, Australia, Canada, Germany, Poland, Puerto Rico, Romania, Slovakia

Related Papers Related Patents Related Grants Related Experts
All trials for Diabetes Mellitus, Type 1 All trials of Insulin icodec All trials of Insulin glargine

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Insulin icodec + insulin aspartExperimentalDrug: Insulin icodec; Drug: Insulin aspartParticipants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
Insulin glargine+ insulin aspartActive comparatorDrug: Insulin glargine; Drug: Insulin aspartParticipants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
  • 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.

+Outcome measures

Primary outcomes

  • Change in glycosylated haemoglobin (HbA1c) [From baseline (week 0) to week 26]: Measured in percentage (%)-points.

Secondary outcomes

  • Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)) [From baseline (week-2-0) to week 22-26]: Measured in %-points.
  • Time spent less than (<)3.0 mmol/L (54 mg/dL) [From week 22 to week 26]: Measured in % of time.
  • Change in time spent greater than (>)10.0 mmol/L (180 mg/dL) [From baseline (week-2-0) to week 22-26]: Measured in %-points.
  • Number of severe hypoglycaemic episodes (level 3) [From baseline (week 0) to week 31]: Measured as number of episodes.
  • Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter) [From baseline (week 0) to week 31]: Measured as number of episodes.
  • Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3) [From baseline (week 0) to week 31]: Measured as number of episodes.
  • Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL]) [From baseline (week 0) to week 31]: Measured as number of episodes.
  • Mean total weekly insulin dose [From week 24 to week 26]: Measured in insulin units.
  • Change in body weight [From baseline (week 0) to week 26]: Measured in Kilogram (kg).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
* Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
* HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
* Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous participation in this study. Participation is defined as signed informed consent.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
* Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
* Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
* Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

+Locations (182)

FacilityCityCountryStatus
Cullman Clinical TrialsCullman, AlabamaUnited States
John Muir HealthConcord, CaliforniaUnited States
Headlands Research California, LLCEscondido, CaliforniaUnited States
Clinical Res of Central CaFresno, CaliforniaUnited States
Providence Medical FoundationFullerton, CaliforniaUnited States
Scripps Whittier Diabetes InstLa Jolla, CaliforniaUnited States
Loma Linda University Faculty Medical ClinicsLoma Linda, CaliforniaUnited States
Pacific Clinical StudiesLos Alamitos, CaliforniaUnited States
Los Angeles Institute for Metabolic ResearchLos Angeles, CaliforniaUnited States
Pasadena Clinical TrialsPasadena, CaliforniaUnited States
WestenU HealthPomona, CaliforniaUnited States
Alliance Clinical NetworkSan Diego, CaliforniaUnited States
Mills Health CenterSan Mateo, CaliforniaUnited States
Center for Endocrine DM and Metabolic DisordersSanta Clarita, CaliforniaUnited States
University Clin InvestigatorsTustin, CaliforniaUnited States
Diablo Clinical Research, Inc.Walnut Creek, CaliforniaUnited States
Denver Endocrinology Diabetes and Thyroid CenterEnglewood, ColoradoUnited States
Optumcare Clinical Trials,LLC-GoldenGolden, ColoradoUnited States
Northeast Research InstituteFleming Island, FloridaUnited States
Encore Medical Research LLCHollywood, FloridaUnited States
Northeast Research InstituteJacksonville, FloridaUnited States
Life Spring Research Foundation LLCMiami, FloridaUnited States
Suncoast Clinical Research, Inc.New Port Richey, FloridaUnited States
West Orange EndocrinologyOcoee, FloridaUnited States
Suncoast Clinical Research, Inc.Palm Harbor, FloridaUnited States
Center for Diab,Obes & MetabPembroke Pines, FloridaUnited States
SRA Trials-BrowardPembroke Pines, FloridaUnited States
Hanson Clinical Research CenterPort Charlotte, FloridaUnited States
Latin Clinical Trial CtrTamarac, FloridaUnited States
Bayside Clinical ResearchTampa, FloridaUnited States
Metabolic Research Institute IncWest Palm Beach, FloridaUnited States
Atlanta Diabetes AssociatesAtlanta, GeorgiaUnited States
Centricity Research ColumbusColumbus, GeorgiaUnited States
Physicians Research Assoc. LLCLawrenceville, GeorgiaUnited States
Endocrine Research Solutions, IncRoswell, GeorgiaUnited States
Rocky Mt Clin Res, LLCIdaho Falls, IdahoUnited States
Northwestern UniversityChicago, IllinoisUnited States
University Of ChicagoChicago, IllinoisUnited States
Endeavor HealthSkokie, IllinoisUnited States
Indiana Uni School of Med-PedIndianapolis, IndianaUnited States
Iowa Diabetes ResearchWest Des Moines, IowaUnited States
Cotton O'Neil Diabetes & EndocrinologyTopeka, KansasUnited States
Robley Rex VA Medical CenterLouisville, KentuckyUnited States
MedStar Health Research InstituteOlney, MarylandUnited States
Brigham & Women's HospitalBoston, MassachusettsUnited States
Profound Research LLCClarkston, MichiganUnited States
Profound Research LLCFarmington Hills, MichiganUnited States
Elite Clinical Research CenterFlint, MichiganUnited States
International Diabetes CenterMinneapolis, MinnesotaUnited States
Mayo ClinicRochester, MinnesotaUnited States
Saint Louis UniversitySt Louis, MissouriUnited States
Washington UniversitySt Louis, MissouriUnited States
QCR NetworkOmaha, NebraskaUnited States
University of Nebraska Medical CenterOmaha, NebraskaUnited States
Palm Research Center Inc.Las Vegas, NevadaUnited States
Albuquerque Clinical Trials Inc.Albuquerque, New MexicoUnited States
AMC Community EndocrinologyAlbany, New YorkUnited States
NYC Research, Inc.New York, New YorkUnited States
NYU Langone Orthopedic CenterNew York, New YorkUnited States
University at BuffaloWilliamsville, New YorkUnited States
Physicians East EndocrinologyGreenville, North CarolinaUnited States
Centricity Rsrch MHCity MultiMorehead City, North CarolinaUnited States
Centricity Res New Bern MultispecialityNew Bern, North CarolinaUnited States
Accellacare of RaleighRaleigh, North CarolinaUnited States
Accellacare WilmingtonWilmington, North CarolinaUnited States
Diab & Endo Assoc of Stark CoCanton, OhioUnited States
Cleveland Clinic_ClevelandCleveland, OhioUnited States
The Ohio State University Medical CenterColumbus, OhioUnited States
Alliance for Multispecialty ResearchNorman, OklahomaUnited States
Lynn Institute of NormanNorman, OklahomaUnited States
Lynn Institute - East OKCOklahoma City, OklahomaUnited States
Thomas Jefferson University HospitalPhiladelphia, PennsylvaniaUnited States
Prisma Health Endo Spc Thy CtrGreenville, South CarolinaUnited States
Holston Medical Group_BristolBristol, TennesseeUnited States
University Diabetes & Endocrine ConsultantsChattanooga, TennesseeUnited States
MidState Endocrine AssociatesNashville, TennesseeUnited States
Vanderbilt Medical Center_NashvilleNashville, TennesseeUnited States
Amarillo Medical SpecialistsAmarillo, TexasUnited States
Texas Diab Endo ATX N Mopac EXPRAustin, TexasUnited States
Texas Diabetes & EndocrinologyAustin, TexasUnited States
Alliance Clinical NetworkDallas, TexasUnited States
Thyroid Endocrinology & Diabetes PADallas, TexasUnited States
Velocity Clinical Res-DallasDallas, TexasUnited States
North Texas Endocrine CenterDallas, TexasUnited States
Research Institute Of DallasDallas, TexasUnited States
Precision Endo - RevivalDenton, TexasUnited States
Epic Medical ResearchDeSoto, TexasUnited States
Frontier Medical CtrEl Paso, TexasUnited States
N. Texas Diab & Endo - PrimeFlower Mound, TexasUnited States
Diabetes and Thyroid Center of Fort WorthFort Worth, TexasUnited States
Houston Endocrinology CenterHouston, TexasUnited States
The Endocrine CenterHouston, TexasUnited States
Amir Ali Hassan, MD, PAHouston, TexasUnited States
RGV Endocrine CenterMcAllen, TexasUnited States
Tekton ResearchMcKinney, TexasUnited States
Be Well Clinical StudiesRound Rock, TexasUnited States
Texas Diabetes & Endocrinology_Round RockRound Rock, TexasUnited States
Northeast Clinical Research of San AntonioSan Antonio, TexasUnited States
Valley Diab. & Endo Comp CtrWeslaco, TexasUnited States
Rio Clinical TrialsOgden, UtahUnited States

82 more sites not listed.

+Investigators

  • Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S