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

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

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.

It had two arms (groups): NNC0471-0119 H then Insulin Aspart (experimental) and Insulin Aspart then NNC0471-0119 H (active comparator).

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

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

The registry classes the interventions as drug.

Who Took Part

43 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-01-29 with completion listed for 2025-07-16.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour (time frame: 0 to 1 hour after bolus infusion).

It also tracked 12 secondary outcomes, for example AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t, GIR(max,basal-corrected): Maximum observed basal-corrected GIR, AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t, AUC(NNC0471-0119,0-30min,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes, C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration and Number of adverse events (AEs).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 43 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.