Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Insulin Aspart.

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

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

The registry classes the interventions as drug.

Who Took Part

530 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 MAIN period (NN5401-3590):. Diagnosis of type 2 diabetes mellitus for at least 6 months. Insulin naïve subjects. Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start. Body Mass Index (BMI) no higher than 40.0 kg/m\^2.

The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: for main period (nn5401-3590):; treatment with glucagon like peptide-1 (glp-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start; cardiovascular disease diagnosed within 6 months before trial start.

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 2010-01 with completion listed for 2010-10.

It ran at 92 sites in United States (41), Spain (11), Russia (10), Austria (6), India (6) 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 2 secondary outcomes, for example Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment and Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 530 people.

With 530 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.