Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart and Insulin Detemir.

This trial is conducted in Europe, Africa and the United States of America (USA).

It had two arms (groups): Advanced (experimental) and Basic (active comparator).

The registry classes the interventions as drug.

Who Took Part

296 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 mellitus for more than 6 months. BMI (Body Mass Index) less than 40 kg/m2. Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily). Treatment with one to 3 OADs.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: known or suspected allergy to trial products or related products; women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks; previous participation in any trial including this for the last 6 months.

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 2007-10 with completion listed for 2009-03.

It ran at 69 sites in United States (20), Spain (7), United Kingdom (7), Finland (6), Netherlands (6) and Norway (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycosylated Haemoglobin A1c (HbA1c) (time frame: week 36). Glycosylated Haemoglobin A1c (HbA1c) (time frame: week 36).

It also tracked 4 secondary outcomes, for example Hypoglycaemic Episodes, Biochemistry: Serum Alanine Aminotransferase, Haematology: Haemoglobin Measured in Blood and Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 296 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.