Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Aspart and Insulin Detemir.

This trial is conducted in Europe.

It had three arms (groups): Insulin detemir (basal insulin) (experimental), Insulin aspart (prandial insulin) (active comparator) and Biphasic insulin aspart 30 (biphasic insulin) (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 708 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. On OAD treatment for at least 4 months with metformin, a sulphonylurea or a combination. Body Mass Index (BMI) below or equal to 40.0 kg/m2.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: proliferative retinopathy; recurrent major hypoglycaemia; cardial problems.

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.

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

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

It started in 2004-11 with completion listed for 2009-08.

It ran at 63 sites in United Kingdom (59) and Ireland (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (Glycosylated Haemoglobin) at Month 12 (time frame: Baseline, Month 12). HbA1c (Glycosylated Haemoglobin) at Month 36 (time frame: Baseline, Month 36).

It also tracked 13 secondary outcomes, for example Percentage of Participants Who Required A Second Insulin Therapy by Month 12, Percentage of Participants Who Required A Second Insulin Therapy by Month 36, Change From Baseline in Body Weight at Month 12, Change From Baseline in Body Weight at Month 36, Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months and Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 708 people.

With 708 participants it is a large trial for this field.

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.