Pilot Study Investigating the Feasibility of Determining the Endogenous Glucose Production During a Hypoglycaemia

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

Population: twenty type 1 diabetic subjects Study design: Single-center, open, non- randomized, pilot-study.

It had 1 arm (groups): Insulin human (Actrapid) (experimental).

The registry classes the interventions as drug.

More on the Plan

Each subject will participate on 3 Visits.

For women in childbearing potential a urine pregnancy test will be performed.

Hypoglycaemic Visit (Visit2): Each subject will be asked to attend the clinical unit at approximately 20:00 in the evening on day 1.

Blood sampling for measurement of plasma glucose, \[6,6-2H2\] glucose (labelled glucose),glucagon, vital signs, hypoglycaemic symptoms questionnaire and hypoglycaemic awareness will be performed at each plasma glucose plateau.

Who Took Part

Enrollment: 20 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: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

The full record lists 1 inclusion and 32 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) as judged by the investigator; severe hypoglycaemia within 1 month of screening.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-01 with completion listed for 2016-03.

It ran at 1 site in Austria.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Tracer to Tracee Ratio (the absolute relative difference ARDi ) (time frame: 8 hours).

It also tracked 1 secondary outcome, for example Tracer to tracee Ratio.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Insulin (regular human) in 20 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, all human trials.