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 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The study will last for about 13-67 days (or a half to 2 months).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: f
View:

• Male or female (sex at birth).

• Age 18-69 years (both inclusive) at the time of signing the informed consent.

• Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening.

• Treated with any injectable insulin, except once-weekly insulin, ≥ 180 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) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening:

• Any metformin formulation

• Dipeptidyl peptidase-4 inhibitor (DPP4i)

• Sodium-glucose Cotransporter-2 inhibitor (SGLT2i)

• Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening.

• HbA1c lesser than or equal to (≤) 9.5%

Locations
Other Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
RECRUITING
Neuss
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-07-11
Estimated Completion Date: 2026-01-12
Participants
Target number of participants: 65
Treatments
Experimental: NNC0471-0119 H then Insulin Aspart
Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.
Active_comparator: Insulin Aspart then NNC0471-0119 H
Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov