Testing a new fast-acting insulin for type 1 diabetes using an insulin pump
A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes
This study is testing a new fast-acting insulin for people with type 1 diabetes to see if it works better than the standard insulin when delivered through an insulin pump.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Neuss) |
| Trial ID | NCT06809621 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a new fast-acting insulin, NNC0471-0119, in individuals with type 1 diabetes when administered via an insulin pump. Participants will receive both the new insulin and a standard insulin (insulin aspart) during separate clinic visits to compare their effects on blood sugar levels. The study will last approximately 1 to 3 months, focusing on how quickly the new insulin enters the bloodstream and its duration of action. The goal is to determine if this new insulin can provide better management of blood sugar levels for patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-64 with a diagnosis of type 1 diabetes for at least one year and currently using an insulin pump.
Not a fit: Patients with known hypersensitivity to the study insulin or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved blood sugar control for patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with fast-acting insulins, suggesting potential for success with this new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged 18-64 years (both inclusive) at the time of signing the informed consent. * Diagnosed with Type 1 Diabetes (T1D) greater than or equal to (≥) 1 year before screening. * Insulin administration using continuous subcutaneous insulin infusion via a pump greater than or equal to (≥) 90 days before screening. * Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day \[(I)U/kg/day\] (both inclusive). Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
Where this trial is running
Neuss
- Profil Institut für Stoffwechselforschung GmbH — Neuss, Germany (Recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.