Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes

What Was Tested

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

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

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs).

Subjects continued their ongoing treatment with OADs in the trial.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 465 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 mellitus (diagnosed clinically) for at least 6 months. Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn \[NPH\] insulin) once daily (OD), for at least 3 months. Ongoing treatment with: metformin with or without other oral antidiabetic drugs (OADs) for at least 3 months prior to randomisation. BMI maximum 40.0 kg/m\^2.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2010-01 with completion listed for 2010-10.

It ran at 65 sites in United States (24), India (8), France (7), South Korea (6), Turkey (Türkiye) (6) and Sweden (5).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 1 secondary outcome, for example Mean of 9-point Self Measured Plasma Glucose Profile (SMPG).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 465 people.

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.