Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This trial is conducted in Japan.

The aim of this trial is to compare biphasic insulin aspart 70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30 (NN-X14Mix30) in healthy volunteers.

It had two arms (groups): BIAsp 70 (experimental) and BIAsp 30 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 59 actual participants took part.

It was open to people of any sex aged from 20 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subjects with type 2 diabetes mellitus. Age between 20-69 years, both inclusive. Body Mass Index (BMI) 18.5-25.0 kg/m\^2. Japanese subjects with considered generally healthy based on medical history and physical examination. Age between 20-29 years, both inclusive.

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: proliferative retinopathy or maculopathy requiring acute treatment; impaired hepatic function; impaired renal function.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2006-06-05 with completion listed for 2007-03-13.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the plasma insulin concentration curve from 0 to 24 hours.

It also tracked 12 secondary outcomes, for example Area under the concentration curve of plasma insulin from 0 to 4 hours after meals, Maximum plasma insulin concentration observed from 0 to 4 hours after meals, Time to reach the maximum plasma insulin concentration from 0 to 4 hours after meals, The 24-hour plasma insulin profile deviances in Japanese type 2 diabetic subjects, Pre-meal plasma glucose concentration before meals and Postprandial plasma glucose (PPPG) excursion from 0 to 4 hours after meals.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 59 people.

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.