Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial

What Was Tested

This randomized controlled trial paper looks at Insulin Aspart.

Who Took Part

The study group was 1,070 subjects.

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

Prospective, multi-centre, randomized, open-labelled, parallel-group trial lasting 6 months in 88 centres in eight European countries and including 1,070 adult subjects with Type 1 diabetes.

Study patients were randomized 2:1 to insulin aspart or unmodified human insulin before main meals, with NPH-insulin as basal insulin.

How the Study Was Run

In design terms this was a randomized, open-label and parallel-group study.

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

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

The Insulin Aspart group and the comparison group ran side by side rather than switching.

The methods mention a period of 6 months.

What Was Measured

PubMed files the paper under topics including Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Hypoglycemia, Hypoglycemic Agents and Insulin.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Insulin Aspart in 1,070 subjects over 6 months.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2000 (Diabetic medicine : a journal of the British Diabetic Association), a journal based in England.

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