Pharmacokinetic and pharmacodynamic properties of long-acting insulin analogue NN304 in comparison to NPH insulin in humans

What Was Tested

This randomized controlled trial paper looks at Insulin Detemir and NPH Insulin (isophane).

NN304 is a long-acting insulin analogue that is acylated with a 14-C-fatty acid chain.

Protraction of action of this novel insulin analogue is due not to slow absorption after subcutaneous administration but to reversible binding to albumin.

Who Took Part

The study group was 10 volunteers.

The age groups tagged for this paper are adults, men only.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and crossover study.

Because people in this Insulin Detemir study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Some volunteers received a placebo instead of Insulin Detemir, giving a reference point.

In the crossover set-up each of the volunteers took both Insulin Detemir and the comparison in turn, acting as their own control.

What Was Measured

PubMed files the paper under topics including Carrier Proteins, Insulin, Insulin Detemir, Insulin, Isophane, Insulin, Long-Acting and Serum Albumin.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Insulin Detemir and NPH Insulin (isophane) in 10 volunteers.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2000 (Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association), a journal based in Germany.

More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.