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Search / Trial NCT07076199

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 03, 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.

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

0 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