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
Launched by NOVO NORDISK A/S · Jul 14, 2025
Trial Information
Current as of October 30, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new type of insulin called insulin icodec, which is taken once a week, to see how well it controls blood sugar compared to the usual daily insulin called insulin glargine. Both insulins will be used together with another insulin called insulin aspart in adults who have type 1 diabetes. The study will last about 8 and a half months and aims to find out if the weekly insulin can work as well as the daily one in managing blood sugar levels.
People who might be eligible for this study are adults aged 18 to 74 who have had type 1 diabetes for at least one year and have been using daily insulin injections for at least six months. Their blood sugar control, measured by a test called HbA1c, should be within a certain range (between 7.0% and 10.0%). Participants need to be willing and able to check their blood sugar regularly during the study. The trial is not yet recruiting, and it excludes people who are pregnant, have certain medical conditions, or have had serious low blood sugar episodes recently. If you join, you can expect to follow the study instructions closely and attend regular check-ups to monitor your health and how well the insulin is working.
Gender
ALL
Eligibility criteria
- 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.
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Rochester, Minnesota, United States
Philadelphia, Pennsylvania, United States
Saint Louis, Missouri, United States
Walnut Creek, California, United States
Minneapolis, Minnesota, United States
Parkville, Victoria, Australia
Hyattsville, Maryland, United States
Winnipeg, Manitoba, Canada
New Port Richey, Florida, United States
Dallas, Texas, United States
Palm Harbor, Florida, United States
Dallas, Texas, United States
Omaha, Nebraska, United States
Norman, Oklahoma, United States
Saint Louis, Missouri, United States
Sibiu, Romania
Calgary, Alberta, Canada
Montreal, Quebec, Canada
Concord, California, United States
Atlanta, Georgia, United States
New York, New York, United States
Louisville, Kentucky, United States
Houston, Texas, United States
San Mateo, California, United States
Port Charlotte, Florida, United States
Halifax, Nova Scotia, Canada
Nashville, Tennessee, United States
Macquarie Park, New South Wales, Australia
Heidelberg Heights, Victoria, Australia
Fort Worth, Texas, United States
Essen, Germany
Roswell, Georgia, United States
Austin, Texas, United States
Bad Oeynhausen, Germany
Cullman, Alabama, United States
Houston, Texas, United States
Chattanooga, Tennessee, United States
West Palm Beach, Florida, United States
Greenville, North Carolina, United States
Lodz, Poland
Lublin, Poland
Brasov, Romania
Fleming Island, Florida, United States
Amarillo, Texas, United States
Ocoee, Florida, United States
Oaklands Park, South Australia, Australia
Williamsville, New York, United States
Loma Linda, California, United States
Ludwigshafen, Germany
Green Bay, Wisconsin, United States
Round Rock, Texas, United States
Mcallen, Texas, United States
Bad Mergentheim, Germany
Norman, Oklahoma, United States
San Antonio, Texas, United States
Gdansk, Poland
Los Alamitos, California, United States
Morehead City, North Carolina, United States
Mckinney, Texas, United States
Mirabel, Quebec, Canada
Wilmington, North Carolina, United States
Escondido, California, United States
Albany, New York, United States
Dallas, Texas, United States
Etobicoke, Ontario, Canada
Saint Ingbert Oberwürzbach, Germany
Wangen, Germany
Round Rock, Texas, United States
Weslaco, Texas, United States
Calgary, Alberta, Canada
Brampton, Ontario, Canada
Laval, Quebec, Canada
Québec, Quebec, Canada
Hamburg, Germany
Krakow, Malopolskie, Poland
Lublin, Poland
Bucharest, Romania
Ploiesti, Romania
Satu Mare, Romania
La Jolla, California, United States
Lawrenceville, Georgia, United States
Boston, Massachusetts, United States
Bristol, Tennessee, United States
Wollongong, New South Wales, Australia
Bayamon, Puerto Rico
Tarnow, Malopolskie, Poland
Renton, Washington, United States
Fitzroy, Victoria, Australia
Berlin, Germany
Gelnhausen, Germany
Hamburg, Germany
Ploiesti, Prahova, Romania
Bacau, Romania
Kosice, Slovakia
Cleveland, Ohio, United States
Galati, Romania
Bratislava, Slovakia
Craiova, Dolj, Romania
Bacau, Romania
Nashville, Tennessee, United States
Constanta, Romania
Dallas, Texas, United States
Bratislava, Slovakia
Poznan, Poland
Kosice, Slovakia
Osnabrück, Germany
Timisoara, Romania
Canton, Ohio, United States
Idaho Falls, Idaho, United States
New York, New York, United States
Vancouver, British Columbia, Canada
Bucuresti, Romania
Tustin, California, United States
Legnica, Poland
Las Vegas, Nevada, United States
Bytca, Slovakia
Chicago, Illinois, United States
Pasadena, California, United States
Oswiecim, Malopolskie, Poland
Flint, Michigan, United States
Columbus, Georgia, United States
Skokie, Illinois, United States
Desoto, Texas, United States
Münster, Germany
Hamilton, Ontario, Canada
Clarkston, Michigan, United States
Townsville, Queensland, Australia
Dresden, Germany
Hamburg, Germany
Kosice, Slovakia
Fresno, California, United States
Fullerton, California, United States
Pomona, California, United States
San Diego, California, United States
Santa Clarita, California, United States
Golden, Colorado, United States
Pembroke Pines, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Topeka, Kansas, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
New Bern, North Carolina, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Greenville, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Denton, Texas, United States
El Paso, Texas, United States
Flower Mound, Texas, United States
Houston, Texas, United States
Ogden, Utah, United States
South Burlington, Vermont, United States
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montréal, Quebec, Canada
Terrebonne, Quebec, Canada
Bochum, Germany
Eisenach, Germany
Poznan, Poland
Zabrze, Poland
Zamość, Poland
Bayamon, Puerto Rico
Suceava, Romania
Patients applied
Trial Officials
Clinical Transparency (dept. 2834)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported