Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart.

This trial is conducted in Europe.

The registry classes the interventions as drug.

Who Took Part

The registry lists 75 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Type 2 diabetes for at least 12 months. Stable glycaemic control, having been on the existing treatment for at least 1 month. BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese). Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: A history of drug abuse or alcohol dependence; blood donation within the last 3 months; currently being treated with systemic corticosteroids, mono amine oxidase (mao) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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 2003-09 with completion listed for 2004-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the serum glucose concentration profile during 24 hours (time frame: after 4 weeks of treatment).

It also tracked 5 secondary outcomes, for example 8-point self-monitored blood glucose profiles, Adverse events and Hypoglycaemic episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 75 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.