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
Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatmentNovo Nordisk A/S
~877 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:Insulin icodecInsulin glargineInsulin aspart
At a glance
Recruiting sites
0 of 182 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in glycosylated haemoglobin (HbA1c)
Measured over From baseline (week 0) to week 26
Conditions
Where it's being run
182 sites across 51 statesTexas22
Germany16
California15
Florida13
Poland13
Romania12
Ontario6
Slovakia6
Study leadership
- Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Change in glycosylated haemoglobin (HbA1c)From baseline (week 0) to week 26
Measured in percentage (%)-points.