Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Detemir and NPH Insulin (isophane).

It had two arms (groups): Insulin detemir (experimental) and NPH insulin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 752 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: Signed and dated informed consent obtained before any trial-related activities. Type 1 diabetes diagnosed and classified according to aetiology. Duration of type 1 diabetes equal to or more than 12 months. Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory. Able and willing to perform self-blood glucose monitoring.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: proliferative retinopathy; recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator); known unawareness of hypoglycaemia.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Everyone knew when Insulin Detemir was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2001-02-01 with completion listed for 2001-11-12.

It ran at 93 sites in United Kingdom (24), France (14), Sweden (10), Norway (9), Australia (8) and Denmark (8).

What Was Measured

Primary outcome: The change in the level of glycosylated haemoglobin(HbA1c) (time frame: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 752 people.

With 752 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 Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.