A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes

What Was Tested

This registered early phase 1 trial tested Insulin (regular human) and Glucagon.

This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.

It had two arms (groups): Insulin IV (active comparator) and Insulin and Glucagon IV (experimental).

Calculated insulin rate.

Calculated molar ratio insulin:glucagon.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 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 patients aged between 18 and 64 years (both inclusive). Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit. Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit.

The full record lists 3 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2020-09-15 with completion listed for 2020-12-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: hypoglycemic excursions (time frame: 180-360 minutes post meal). hyperglycemic excursions (time frame: 60-120 minutes post meal).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin (regular human) and Glucagon in 15 people.

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

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

More context: the Insulin (regular human) compound page and the Glucagon compound page, all human trials.