Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

What Was Tested

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

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

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

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

The registry classes the interventions as drug.

Who Took Part

548 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: FOR THE MAIN TRIAL, NN5401-3594:. Type 1 diabetes mellitus for at least 12 months. Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months. BMI (Body Mass Index) below or equal to 35.0 kg/m\^2. FOR THE EXTENSION TRIAL, NN5401-3645:.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: FOR THE MAIN TRIAL, NN5401-3594:; treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months; cardiovascular disease within the last 6 months.

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.

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

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

It started in 2009-08 with completion listed for 2010-05.

It ran at 81 sites in United States (30), Russia (11), Romania (8), United Kingdom (8), Australia (7) and Poland (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (time frame: Week 0, Week 26). Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (time frame: Week 0 to Week 53 + 7 days follow up). Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (time frame: Week 0 to Week 53 + 7 days follow up).

It also tracked 5 secondary outcomes, for example Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes, Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26, Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment, Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes and Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 548 people.

With 548 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 and the Insulin Detemir compound page, all human trials.