A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

This trial is conducted globally.

The trial is an extension to trial NN5401-3941 (NCT01680341).

It had two arms (groups): IDegAsp BID + IAsp OD (experimental) and IDeg OD + IAsp TID (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: impaired liver function, defined as alanine aminotransferase (alat) or aspartate aminotransferase (asat) equal to or above 2.5 times upper limit of normal.

How the Study Was Run

Design: 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.

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 2013-03 with completion listed for 2014-03.

It ran at 40 sites in United States (26), Germany (5), Turkey (Türkiye) (4), Algeria (3) and Malaysia (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26).

It also tracked 4 secondary outcomes, for example Incidence of Treatment Emergent Adverse Events (TEAEs), Number of Treatment Emergent Hypoglycaemic Episodes, Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes and Change From Baseline in Fasting Plasma Glucose (FPG).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 40 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.