Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Detemir.

To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes \- The patient serves as his own control, n=100 patients with diabetes.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Insulin detemir.

Saline.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI: 20-35 kg/m2. Insulin detemir naive.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: known allergy to study drug; current steroid or antiallergic treatment; change in insulin and antihypertensive treatment \< 30 days.

How the Study Was Run

It was run as a randomized, factorial and quadruple-blind study.

The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Insulin Detemir, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-01 with completion listed for 2009-06.

It ran at 1 site in Denmark.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): laser doppler blood flow (time frame: 10 minutes - 7 days).

It also tracked 2 secondary outcomes, for example clinical signs and insulin detemir specific antibodies.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 40 people.

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.