Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Aspart.

Primary Objective: * To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes.

It had two arms (groups): insulin glulisine + insulin aspart (experimental) and insulin aspart + insulin glulisine (experimental).

Insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day).

Insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 37 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: Patients with type 2 diabetes for at least one year. Treated with oral antidiabetic agents (OADs) for at least 6 months. BMI (body mass index) between 30 and 40 kg/m2. Signed informed consent.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: type i diabetes mellitus; current treatment with insulin; pregnant and breast-feeding women.

How the Study Was Run

It was run as a randomized, crossover and double-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.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant and investigator.

It started in 2007-09 with completion listed for 2008-04.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h) (time frame: At day 1 of each treatment period).

It also tracked 16 secondary outcomes, for example Area under the curve of plasma glucose concentration AUC(0-2h), Area under the curve of plasma glucose concentration AUC(0-4h), Area under the curve of plasma glucose concentration AUC(0-6h), Delta plasma glucose at 1h after standard meal, Maximum glucose concentration (GLU max) and Maximum glucose excursion (delta GLU max).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 37 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 Aspart compound page, all human trials.