Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

This trial is conducted in Japan.

The registry classes the interventions as drug.

Who Took Part

The registry lists 9 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. Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks. No previous treatment with insulin and/or SU agents. Body Mass Index (BMI) below 30.0 kg/m2.

The full record lists 5 inclusion and 7 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.

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 2005-12 with completion listed for 2006-04.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: after 24 weeks of treatment).

It also tracked 2 secondary outcomes, for example Plasma glucose levels.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 9 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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