Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin.

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

One Day Treatment with Insulin Glulisine.

One day Treatment with Human insulin.

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 40 years up to 70 years.

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

Examples of who could join: Type 2 Diabetes mellitus according to the ADA criteria. Age between 40 and 70 years. BMI \< 40.

The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: type 1 diabetes mellitus; pre-treatment with insulin within the last 6 months prior to screening; treatment with glitazones within the last 6 months prior to screening.

How the Study Was Run

Design: 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 2006-12 with completion listed for 2007-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin (time frame: 1 day).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) 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, all human trials.