Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 2) is built around Insulin Aspart.

This trial is conducted in Europe.

The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

It had three arms (groups): SIAC 30 (B) (experimental), SIAC 45 (B) (experimental) and BIAsp 30 (active comparator).

The registry classes the interventions as drug.

Who Took Part

182 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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 procedure that would not have been performed during normal management of the subject.). Body Mass Index (BMI), 25.0-37.0 kg/m\^2 (both inclusive).

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: metformin contraindication according to local practice; thiazolidinedione (tzd) treatment within previous 3 months prior to visit 1.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2008-01 with completion listed for 2008-08.

It ran at 31 sites in Poland (8), France (7), Germany (7), Spain (5) and Finland (4).

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 16).

It also tracked 11 secondary outcomes, for example Mean of 9-point Self Measured Plasma Glucose Profile (SMPG), Rate of Major and Minor Hypoglycaemic Episodes, Rate of Nocturnal Major and Minor Hypoglycaemic Episodes, Rate of Treatment Emergent Adverse Events (AEs), Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) and Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 182 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.