Experimental testing of skin reactions to insulin detemir in diabetes patients naïve to insulin detemir

What Was Tested

This randomized controlled trial looks at Insulin Detemir.

Sporadic reports on immediate and delayed cutaneous reactions to insulin detemir, a modern insulin analogue, have raised unsupported claims of allergy of type I, III and IV.

The purpose of this experimental study using a provocative design was to elucidate the potential mechanisms behind such skin reactions.

Who Took Part

The study group was 40 patients.

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

A total of 40 patients with type 1 diabetes or insulin-requiring type 2 diabetes, all naïve to insulin detemir, were injected on the thigh with 0.l mL of insulin detemir (Levemir(®)) administered with an 8 mm needle at three different depths, i.e. intradermal, subdermal and subcutaneously.

How the Study Was Run

The researchers set it up as a randomized and double-blind study.

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

As a double-blind Insulin Detemir study, the assignments were hidden from both participants and investigators until the end.

Saline was injected as control.

Histopathology of positive reactions on day 7 was obtained.

The study was randomized, controlled, double-blinded, and conducted in accordance with ICH-GCP guidelines.

Blood flow was recorded with the Periflux PF5010, and skin colour (a*) with the DSMII colorimeter.

What Was Measured

Topics PubMed links to this paper include Antibodies, Colorimetry, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Drug Eruptions, Histamine and Hypersensitivity, Delayed.

What This Means in Plain Language

The paper is a randomized and double-blind study of Insulin Detemir in 40 patients.

Results are reported in around 11 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2011 (Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI)), a journal based in England.

More context: the Insulin Detemir compound page, all human trials.