Effect of Apidra Compared to Humalog in Decreasing Post-Prandial Hyperglycemia

What Was Tested

The trial (not phased) is built around Insulin Aspart and Insulin Lispro.

This study aims to compare the post-meal blood glucose values of two drugs in a "real-world" setting.

It had three arms (groups): Humalog (active comparator), Apidra (active comparator) and Novolog (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog) insulin in a real-world setting.

The difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.

Who Took Part

Enrollment: 107 actual participants took part.

It was open to people of any sex aged from 9 years up to 14 years.

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

Examples of who could join: Diagnosis of type 1 Diabetes.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: only campers participating in sessions i and ii are eligible to participate.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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

It started in 2011-06 with completion listed for 2012-08.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch (time frame: averaged over 5 days).

It also tracked 2 secondary outcomes, for example Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner and Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart and Insulin Lispro in 107 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page and the Insulin Lispro compound page, all human trials.