Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin (regular human) and Insulin Aspart.

This trial is conducted in Europe.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 19 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

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

Examples of who could join: Type 2 diabetes. Duration of diabetes for at least 12 months. Current treatment with human insulin or insulin analogues for at least 6 months. BMI equal to or below 35 kg/m2.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: current treatment with systemic corticosteroids; any positive reaction of drug of abuse or alcohol screen; cardiac problems defined as: decompensated heart failure and/or angina pectoris.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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.

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

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

It started in 2002-01-10 with completion listed for 2002-07-19.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glucose infusion rate (time frame: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))).

It also tracked 10 secondary outcomes, for example AUCGIR(0-300 min) the area under the GIR profile, AUCGIR(0 min-end of clamp) the area under the GIR profile, AUCGIR(300min-end of clamp) the area under the GIR profile, GIRmax: the maximal GIR value, AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile and AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 19 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 Insulin Aspart compound page, all human trials.