Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Aspart and Insulin Detemir.

This trial is conducted in Europe.

The registry classes the interventions as drug.

Who Took Part

520 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Type 1 diabetes for more than 1 year. Subject treated by any kind of insulin regimen and whatever the number of injections.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: type 2 diabetes; treatment by oral anti-diabetic drugs; severe medical conditions.

How the Study Was Run

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

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.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2005-06 with completion listed for 2006-10.

It ran at 3 sites in Belgium (1), France (1) and Luxembourg (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean HbA1c (time frame: after 4 months of insulin detemir treatment).

It also tracked 6 secondary outcomes, for example HbA1c, Adverse events, Weight, Blood glucose and Hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 520 people.

With 520 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.