Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

This trial is conducted in Japan.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 20 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 1 year. Body Mass Index (BMI) maximum 30.0 kg/m\^2.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: recurrent severe hypoglycaemia; proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks; impaired hepatic function.

How the Study Was Run

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

Because people in this Insulin Aspart 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 Aspart and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant and investigator.

It started in 2001-02 with completion listed for 2001-04.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The maximum insulin aspart concentration.

It also tracked 9 secondary outcomes, for example The area under the insulin aspart curve, tmax, the time to maximum insulin aspart concentration, t½, terminal half-life, The area under the glucose infusion rate (GIR) profile, GIRmax, maximum glucose infusion rate value and tmaxGIR, time to maximum glucose infusion rate value.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 10 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.