A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial

What Was Tested

The trial (phase 1) is built around Insulin Lispro and Insulin Detemir.

Duration of action of insulin detemir has been reported to be up to 24 hours.9,10,11 It has, however, been proposed that the mean duration of action is underestimated in glucose clamps lasting only 24 hours.

This is so because a duration of action longer than 24 hours in individual clamps will be set to 24 hours in the mean calculation, whereas a shorter duration of action in individual clamps will be set to the true value.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

Trial design: This is a randomised, single centre, double-blind, two-period crossover trial.

Trial population: Thirty (30) male and female subjects with type 1 diabetes \[age 18-65 years (incl.) and body mass index between 18.0 and 32.0 kg/m2 (incl.)\] will be randomised into the trial.

Safety: Adverse events, laboratory safety variables (haematology, biochemistry, urinalysis), physical examination, vital signs and hypoglycaemic episodes.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 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. Diagnosed with type 1 diabetes and treated with insulin. Male or female subject between 18 and 65 years of age. Body mass index between 18.0 and 32.0 kg/m2. Treatment with intensified insulin therapy or continuous subcutaneous human insulin or insulin analogue infusion (CSII)\] for at least 3 months.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: known or suspected allergy to the trial products or related products,; previous participation (randomised) in this trial; the receipt of any investigational product within 3 months prior.

How the Study Was Run

Design: randomized, crossover and double-blind.

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2008-11 with completion listed for 2008-12.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Duration of action, time from onset of action until end of action (time frame: 32 h).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro and Insulin Detemir in 30 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 Lispro compound page and the Insulin Detemir compound page, all human trials.