Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes

What Was Tested

This registered phase 1, phase 2 trial tested Insulin Lispro.

The researchers will investigate if Lyumjev premixed with nanogram amounts of glucagon speed up the absorption of insulin and the effect on whole body glucose consumption compared to native lyumjev in patients with type 1 diabetes.

To do that the researchers will perform euglycemic clamps investigations in patients meetinng fasting in the morning on two separate days.Frequent samples for glucose and insulin measuremenst will be drawn and the day with lyumjev only will be compared to the day with premixed Lyumjev.

It had two arms (groups): Lyumjev (active comparator) and Premixed Lyumjev (experimental).

The registry classes the interventions as drug.

More on the Plan

Thus, the researchers hypothesize that adding micro-amounts of glucagon to an insulin solution will speed up the absorption of insulin and the effect on glucose metabolism.

Objective To study if adding micro-amounts of glucagon to a fast-acting insulin (Lyumjev®) before injection speed up the absorption of and effect on glucose metabolism of SC injected insulin.

Trial design Open, prospective, controlled, single centre investigation where patients with T1D are their own controls.

They will meet fasting in the morning on two separate days and receive a SC injection with insulin on both days.

Who Took Part

The registry lists 9 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: T1D for at least one year. Age 18 - 70 years. Treated with an insulin pump or a hybrid artificial pancreas (AP).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: pregnant women or women trying to conceive (women will not be screened by a pregnancy test); any chronic disease, including psychiatric illnesses, judged incompatible with participation in the study; unfit for participation for any reason as judged by the investigators.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-04-01 with completion listed for 2026-02-26.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the glucose consumption curve (time frame: First 30 minutes). Area under the insulin curve Area under the insulin curve (time frame: First 30 minutes).

It also tracked 2 secondary outcomes, for example Area under the glucose consumption curve and Area under the insulin curve.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin Lispro in 9 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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