A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

This trial is conducted in Asia.

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.

It had two arms (groups): IDegAsp BID (experimental) and BIAsp 30 BID (active comparator).

The registry classes the interventions as drug.

Who Took Part

424 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: Male or female at least 18 years of age (at least 20 years for Japan). Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months. Body mass index (BMI) maximum 35.0 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 Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2010-02-01 with completion listed for 2010-12-23.

It ran at 46 sites in Japan (16), South Korea (16), Malaysia (8), Taiwan (5) and Hong Kong (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment (time frame: Week 0, Week 26).

It also tracked 4 secondary outcomes, for example Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26, Rate of Confirmed Hypoglycaemic Episodes, Rate of Nocturnal Confirmed Hypoglycaemic Episodes and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 424 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.