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
| Registry | NCT07076199, acronym ONWARDS 11 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 877 (Estimated) |
| Sponsor | Novo Nordisk A/S (Industry) |
| Conditions | Diabetes Mellitus, Type 1 |
| Interventions | Insulin icodec, Insulin glargine, Insulin aspart (Drug) |
| Dates | start 2025-08-11, primary completion 2027-01-25 (estimated), completion 2027-03-01 (estimated), first posted 2025-07-22, last updated 2026-09-25 |
| Locations | 182 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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Insulin icodec + insulin aspart | Experimental | Drug: Insulin icodec; Drug: Insulin aspart | Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart . |
| Insulin glargine+ insulin aspart | Active comparator | Drug: Insulin glargine; Drug: Insulin aspart | Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart. |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Cullman Clinical Trials | Cullman, Alabama | United States | |
| John Muir Health | Concord, California | United States | |
| Headlands Research California, LLC | Escondido, California | United States | |
| Clinical Res of Central Ca | Fresno, California | United States | |
| Providence Medical Foundation | Fullerton, California | United States | |
| Scripps Whittier Diabetes Inst | La Jolla, California | United States | |
| Loma Linda University Faculty Medical Clinics | Loma Linda, California | United States | |
| Pacific Clinical Studies | Los Alamitos, California | United States | |
| Los Angeles Institute for Metabolic Research | Los Angeles, California | United States | |
| Pasadena Clinical Trials | Pasadena, California | United States | |
| WestenU Health | Pomona, California | United States | |
| Alliance Clinical Network | San Diego, California | United States | |
| Mills Health Center | San Mateo, California | United States | |
| Center for Endocrine DM and Metabolic Disorders | Santa Clarita, California | United States | |
| University Clin Investigators | Tustin, California | United States | |
| Diablo Clinical Research, Inc. | Walnut Creek, California | United States | |
| Denver Endocrinology Diabetes and Thyroid Center | Englewood, Colorado | United States | |
| Optumcare Clinical Trials,LLC-Golden | Golden, Colorado | United States | |
| Northeast Research Institute | Fleming Island, Florida | United States | |
| Encore Medical Research LLC | Hollywood, Florida | United States | |
| Northeast Research Institute | Jacksonville, Florida | United States | |
| Life Spring Research Foundation LLC | Miami, Florida | United States | |
| Suncoast Clinical Research, Inc. | New Port Richey, Florida | United States | |
| West Orange Endocrinology | Ocoee, Florida | United States | |
| Suncoast Clinical Research, Inc. | Palm Harbor, Florida | United States | |
| Center for Diab,Obes & Metab | Pembroke Pines, Florida | United States | |
| SRA Trials-Broward | Pembroke Pines, Florida | United States | |
| Hanson Clinical Research Center | Port Charlotte, Florida | United States | |
| Latin Clinical Trial Ctr | Tamarac, Florida | United States | |
| Bayside Clinical Research | Tampa, Florida | United States | |
| Metabolic Research Institute Inc | West Palm Beach, Florida | United States | |
| Atlanta Diabetes Associates | Atlanta, Georgia | United States | |
| Centricity Research Columbus | Columbus, Georgia | United States | |
| Physicians Research Assoc. LLC | Lawrenceville, Georgia | United States | |
| Endocrine Research Solutions, Inc | Roswell, Georgia | United States | |
| Rocky Mt Clin Res, LLC | Idaho Falls, Idaho | United States | |
| Northwestern University | Chicago, Illinois | United States | |
| University Of Chicago | Chicago, Illinois | United States | |
| Endeavor Health | Skokie, Illinois | United States | |
| Indiana Uni School of Med-Ped | Indianapolis, Indiana | United States | |
| Iowa Diabetes Research | West Des Moines, Iowa | United States | |
| Cotton O'Neil Diabetes & Endocrinology | Topeka, Kansas | United States | |
| Robley Rex VA Medical Center | Louisville, Kentucky | United States | |
| MedStar Health Research Institute | Olney, Maryland | United States | |
| Brigham & Women's Hospital | Boston, Massachusetts | United States | |
| Profound Research LLC | Clarkston, Michigan | United States | |
| Profound Research LLC | Farmington Hills, Michigan | United States | |
| Elite Clinical Research Center | Flint, Michigan | United States | |
| International Diabetes Center | Minneapolis, Minnesota | United States | |
| Mayo Clinic | Rochester, Minnesota | United States | |
| Saint Louis University | St Louis, Missouri | United States | |
| Washington University | St Louis, Missouri | United States | |
| QCR Network | Omaha, Nebraska | United States | |
| University of Nebraska Medical Center | Omaha, Nebraska | United States | |
| Palm Research Center Inc. | Las Vegas, Nevada | United States | |
| Albuquerque Clinical Trials Inc. | Albuquerque, New Mexico | United States | |
| AMC Community Endocrinology | Albany, New York | United States | |
| NYC Research, Inc. | New York, New York | United States | |
| NYU Langone Orthopedic Center | New York, New York | United States | |
| University at Buffalo | Williamsville, New York | United States | |
| Physicians East Endocrinology | Greenville, North Carolina | United States | |
| Centricity Rsrch MHCity Multi | Morehead City, North Carolina | United States | |
| Centricity Res New Bern Multispeciality | New Bern, North Carolina | United States | |
| Accellacare of Raleigh | Raleigh, North Carolina | United States | |
| Accellacare Wilmington | Wilmington, North Carolina | United States | |
| Diab & Endo Assoc of Stark Co | Canton, Ohio | United States | |
| Cleveland Clinic_Cleveland | Cleveland, Ohio | United States | |
| The Ohio State University Medical Center | Columbus, Ohio | United States | |
| Alliance for Multispecialty Research | Norman, Oklahoma | United States | |
| Lynn Institute of Norman | Norman, Oklahoma | United States | |
| Lynn Institute - East OKC | Oklahoma City, Oklahoma | United States | |
| Thomas Jefferson University Hospital | Philadelphia, Pennsylvania | United States | |
| Prisma Health Endo Spc Thy Ctr | Greenville, South Carolina | United States | |
| Holston Medical Group_Bristol | Bristol, Tennessee | United States | |
| University Diabetes & Endocrine Consultants | Chattanooga, Tennessee | United States | |
| MidState Endocrine Associates | Nashville, Tennessee | United States | |
| Vanderbilt Medical Center_Nashville | Nashville, Tennessee | United States | |
| Amarillo Medical Specialists | Amarillo, Texas | United States | |
| Texas Diab Endo ATX N Mopac EXPR | Austin, Texas | United States | |
| Texas Diabetes & Endocrinology | Austin, Texas | United States | |
| Alliance Clinical Network | Dallas, Texas | United States | |
| Thyroid Endocrinology & Diabetes PA | Dallas, Texas | United States | |
| Velocity Clinical Res-Dallas | Dallas, Texas | United States | |
| North Texas Endocrine Center | Dallas, Texas | United States | |
| Research Institute Of Dallas | Dallas, Texas | United States | |
| Precision Endo - Revival | Denton, Texas | United States | |
| Epic Medical Research | DeSoto, Texas | United States | |
| Frontier Medical Ctr | El Paso, Texas | United States | |
| N. Texas Diab & Endo - Prime | Flower Mound, Texas | United States | |
| Diabetes and Thyroid Center of Fort Worth | Fort Worth, Texas | United States | |
| Houston Endocrinology Center | Houston, Texas | United States | |
| The Endocrine Center | Houston, Texas | United States | |
| Amir Ali Hassan, MD, PA | Houston, Texas | United States | |
| RGV Endocrine Center | McAllen, Texas | United States | |
| Tekton Research | McKinney, Texas | United States | |
| Be Well Clinical Studies | Round Rock, Texas | United States | |
| Texas Diabetes & Endocrinology_Round Rock | Round Rock, Texas | United States | |
| Northeast Clinical Research of San Antonio | San Antonio, Texas | United States | |
| Valley Diab. & Endo Comp Ctr | Weslaco, Texas | United States | |
| Rio Clinical Trials | Ogden, Utah | United States |
82 more sites not listed.