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Clinical Trials in the USA / NCT07076199
Active, not recruiting Phase 3

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

NCT07076199 · tracked via the Priya Life Science USA tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2025-08-11
Last updated
2026-09-01

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

Insulin icodecInsulin glargineInsulin aspart

Insulin icodec: Insulin icodec will be administered as subcutaneous injection

Insulin glargine: Insulin glargine will be administered as subcutaneous injection.

Insulin aspart: Insulin aspart will be administered as a subcutaneous injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (182)

FacilityCityRegionStatus
Cullman Clinical Trials Cullman Alabama
John Muir Health Concord California
Headlands Research California, LLC Escondido California
Clinical Res of Central Ca Fresno California
Providence Medical Foundation Fullerton California
Scripps Whittier Diabetes Inst La Jolla California
Loma Linda University Faculty Medical Clinics Loma Linda California
Pacific Clinical Studies Los Alamitos California
Los Angeles Institute for Metabolic Research Los Angeles California
Pasadena Clinical Trials Pasadena California
WestenU Health Pomona California
Alliance Clinical Network San Diego California
Mills Health Center San Mateo California
Center for Endocrine DM and Metabolic Disorders Santa Clarita California
University Clin Investigators Tustin California
Diablo Clinical Research, Inc. Walnut Creek California
Denver Endocrinology Diabetes and Thyroid Center Englewood Colorado
Optumcare Clinical Trials,LLC-Golden Golden Colorado
Northeast Research Institute Fleming Island Florida
Encore Medical Research LLC Hollywood Florida
Northeast Research Institute Jacksonville Florida
Life Spring Research Foundation LLC Miami Florida
Suncoast Clinical Research, Inc. New Port Richey Florida
West Orange Endocrinology Ocoee Florida
Suncoast Clinical Research, Inc. Palm Harbor Florida
Center for Diab,Obes & Metab Pembroke Pines Florida
SRA Trials-Broward Pembroke Pines Florida
Hanson Clinical Research Center Port Charlotte Florida
Latin Clinical Trial Ctr Tamarac Florida
Bayside Clinical Research Tampa Florida
Metabolic Research Institute Inc West Palm Beach Florida
Atlanta Diabetes Associates Atlanta Georgia
Centricity Research Columbus Columbus Georgia
Physicians Research Assoc. LLC Lawrenceville Georgia
Endocrine Research Solutions, Inc Roswell Georgia
Rocky Mt Clin Res, LLC Idaho Falls Idaho
Northwestern University Chicago Illinois
University Of Chicago Chicago Illinois
Endeavor Health Skokie Illinois
Indiana Uni School of Med-Ped Indianapolis Indiana

+ 142 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07076199 on ClinicalTrials.gov ↗ ← All trials in the USA