Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart and Insulin Detemir.

This trial is conducted in Europe.

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 719 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: Type 2 diabetes. Duration of type 2 diabetes for at least 6 months since diagnosis. BMI below 40 kg/m2. Able and willing to perform self-monitoring of capillary blood glucose.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: current antidiabetic treatment with combination of three or more oral antidiabetic drugs; known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator; known or suspected allergy to trial product or related products.

How the Study Was Run

The set-up was 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.

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 2003-12-02 with completion listed for 2005-03-03.

It ran at 127 sites in Germany (117), Austria (5) and Switzerland (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: after 6 months of treatment).

It also tracked 5 secondary outcomes, for example Incidence of hypoglycaemic episodes, Adverse events, Difference of HbA1c change between the two groups, Fasting plasma glucose of treatment and Change in weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 719 people.

With 719 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.