A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin Pump

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insulin aspart; Drug: NNC0471-0119 H

Study type: Interventional

Funder types: Industry

Identifiers

NCT06809621

2024-513472-18 (Other Identifier)

NN1471-7712

U1111-1306-8005 (Other Identifier)

Details and patient eligibility

About

The study is looking at the effect and safety of a new fast-acting insulin (NNC0471 0119) to people with type 1 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters your 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 participants will get each study medicine administered at separate clinic visits. The study will last for about 1-3 months.

Enrollment: 43 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups

NNC0471-0119 H then Insulin Aspart

Experimental group

Description:

Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.

Treatment:

Drug: Insulin aspart

Drug: NNC0471-0119 H

Insulin Aspart then NNC0471-0119 H

Active Comparator group

Description:

Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.

Treatment:

Drug: Insulin aspart

Drug: NNC0471-0119 H