A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve 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 Africa, Asia and Europe.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 394 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 procedure that would not have been performed during normal management of the subject). Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening. Insulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days. Insulin naïve subject; allowed is: Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days). Body mass index (BMI) below or equal to 40.0 kg/m\^2.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: treatment with thiazolidinediones (tzds) or glucagon like peptide 1 (glp-1) receptor agonists within 12 weeks prior to visit 1 (screening); previous participation in this trial. participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period; known or suspected hypersensitivity to trial products or related products.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2012-01-16 with completion listed for 2012-11-19.

It ran at 49 sites in Bulgaria (7), Ukraine (7), Germany (6), Croatia (5), Poland (5) and Romania (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26).

It also tracked 6 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG), Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes, Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes, Change From Baseline in Body Weight and Number of Treatment Emergent AEs (Adverse Events).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 394 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.