Condition: Diabetes Mellitus, Type 1 · Sponsor: Novo Nordisk A/S
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Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
Novo Nordisk · (+1) 866-867-7178 · clinicaltrials@novonordisk.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Cullman Clinical Trials | Cullman, Alabama, United States | Completed |
| John Muir Health | Concord, California, United States | Recruiting |
| Headlands Research California, LLC | Escondido, California, United States | Completed |
| Clinical Res of Central Ca | Fresno, California, United States | Recruiting |
| Providence Medical Foundation | Fullerton, California, United States | Active Not Recruiting |
| Scripps Whittier Diabetes Inst | La Jolla, California, United States | Completed |
| Loma Linda University Faculty Medical Clinics | Loma Linda, California, United States | Recruiting |
| Loma Linda University Faculty Medical Clinics | Loma Linda, California, United States | Not Yet Recruiting |
| Pacific Clinical Studies | Los Alamitos, California, United States | Active Not Recruiting |
| Los Angeles Institute for Metabolic Research | Los Angeles, California, United States | Active Not Recruiting |
| Pasadena Clinical Trials | Pasadena, California, United States | Recruiting |
| WestenU Health | Pomona, California, United States | Completed |
+ 184 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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