Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

It had two arms (groups): IDegAsp Simple (experimental) and IDegAsp Step wise (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 272 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: Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation). Body mass index (BMI) below or equal to 40 kg/m\^2.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: treatment with glucagon-like peptide 1 (glp-1) receptor agonists or thiazolidinediones (tzds) both within the last 12 weeks prior to visit 2 (randomisation); recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator; life-threatening disease (e.g. cancer).

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.

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

It started in 2012-08-31 with completion listed for 2013-08-22.

It ran at 45 sites in United States (28), Germany (6), Turkey (Türkiye) (5), Algeria (3) and Malaysia (3).

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

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 272 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.