Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

What Was Tested

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

This trial is conducted in Japan.

The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

It had two arms (groups): SIBA (experimental) and Insulin Detemir (active comparator).

The registry classes the interventions as drug.

Who Took Part

65 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects with type 1 diabetes mellitus more than one year. Body Mass Index (BMI) below 30.0 kg/m\^2.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: known hypoglycaemia unawareness or recurrent major hypoglycaemia; current treatment or expected to start treatment with systemic corticosteroid.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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 2009-01 with completion listed for 2009-05.

It ran at 8 sites in Japan (8).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Rate of Major and Minor Hypoglycaemic Episodes (time frame: Week 0 to Week 6 + 5 days follow up). Rate of Nocturnal Major and Minor Hypoglycaemic Episodes (time frame: Week 0 to Week 6 + 5 days follow up).

It also tracked 5 secondary outcomes, for example Number of Treatment Emergent Adverse Events (AEs), Change in Body Weight, Electrocardiogram (ECG), Diastolic Blood Pressure (BP) and Systolic Blood Pressure (BP).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart and Insulin Detemir in 65 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 and the Insulin Detemir compound page, all human trials.