Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted in Asia.

It had two arms (groups): IDegAsp BID (experimental) and BIAsp 30 BID (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 543 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.

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female at least 18 years of age. Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months. Body mass index (BMI) equal or below 40.0 kg/m\^2.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: previous participation in this trial. participation is defined as screened; known or suspected hypersensitivity to trial products or related products.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2016-05-03 with completion listed for 2017-05-19.

It ran at 42 sites in China (42).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) (time frame: At 26 weeks).

It also tracked 47 secondary outcomes, for example Change From Baseline in FPG (Fasting Plasma Glucose), Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes, Number of Treatment Emergent Confirmed Hypoglycaemic Episodes, Change From Baseline in Body Weight, Incidence of Treatment Emergent Adverse Events (TEAEs) and 9-point Profile (SMPG) After 26 Weeks of Treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 543 people.

With 543 participants it is a large trial for this field.

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.