Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 2 trial tested Insulin Aspart.

This trial is conducted in Japan.

The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.

It had two arms (groups): Mix30 (active comparator) and SIAC (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 66 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: Subjects with type 2 diabetes mellitus. Body Mass Index (BMI) \< 30.0 kg/m\^2.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: known hypoglycaemia unawareness or recurrent major hypoglycaemia; current treatment or expected to start treatment with systemic corticosteroid; treatment with oral anti-diabetic drugs (oads: including alpha-glucosidase inhibitor and insulin sensitizer \[thiazolidinedione: tzd\]) within the last 12 weeks prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2009-01 with completion listed for 2009-06.

It ran at 8 sites in Japan (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Rate of Major and Minor Hypoglycaemic Episodes (time frame: Week 0 to Week 6 + 5 days follow up). Rate of Nocturnal Major and Minor Hypoglycaemic Episodes (time frame: Week 0 to Week 6 + 5 days follow up).

It also tracked 5 secondary outcomes, for example Number of Treatment Emergent Adverse Events (AEs), Change in Body Weight, Electrocardiogram (ECG) Worsening, Diastolic BP (Blood Pressure) and Systolic BP (Blood Pressure).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 66 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, all human trials.