A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin Pump

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07068295

U1111-1283-0507 (Other Identifier)

NN1471-5026

2024-520230-29 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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%

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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65 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: NNC0471-0119 H

Drug: Insulin Aspart

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: NNC0471-0119 H

Drug: Insulin Aspart