Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted in the United States of America (USA).

The registry classes the interventions as drug.

Who Took Part

The registry lists 5652 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: BMI \<= 45.0 kg/m2. Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (mao) inhibitors; proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months; any glucose lowering medication that is not indicated in combination with insulin, such as glp-1 analogues.

How the Study Was Run

Design: 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.

Nothing was hidden in this open-label Insulin Detemir study: the participants and staff both knew the treatment.

It started in 2005-10 with completion listed for 2006-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Comparison of the change from baseline to end of treatment (time frame: after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group).

It also tracked 6 secondary outcomes, for example Spontaneously reported adverse events during the trial, Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am), FPG during the trial (central laboratory) at Visit 2 and Visit 3 and Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 5652 people.

With 5652 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, all human trials.