A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification

What Was Tested

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

Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.

It had two arms (groups): IDegAsp (experimental) and IGlar + IAsp (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 532 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. Diagnosed with type 2 diabetes mellitus. Treated with any basal insulin for at least 90 days prior to the day of screening. Body mass index (BMI) equal to or below 45.0 kg/m\^2.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: participation in any clinical trial of an approved or non-approved investigational medicinal product within four weeks prior to the day of screening (v1); any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol; impaired liver function, defined as alanine aminotransferase (alt) equal to or above 2.5 times upper normal limit (unl) at screening.

How the Study Was Run

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

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

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-09-20 with completion listed for 2017-08-31.

It ran at 71 sites in United States (30), Russia (11), India (10), Turkey (Türkiye) (8), Czechia (6) and Algeria (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (%) - Week 26 (time frame: Week 0, week 26).

It also tracked 11 secondary outcomes, for example Change in HbA1c (%) - Week 38, Change in FPG, Change in Pre-breakfast SMPG (Used for Titration), Change in Postprandial SMPG Increment (From 9-point Profile), Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 532 people.

With 532 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 Glargine compound page and the Insulin Aspart compound page, all human trials.