Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects

What Was Tested

This randomized controlled trial paper looks at Insulin Aspart.

The objective of the study was a comparison of insulin aspart (IAsp) with human insulin (HI) in basal-bolus therapy with neutral protamine Hagedorn for fetal and perinatal outcomes of type 1 diabetes in pregnancy.

Who Took Part

PubMed indexes the participants as adults, both men and women.

Subjects were pregnant (gestational age; <10 weeks) or planning pregnancy at enrollment.

Three hundred twenty-two women with type 1 diabetes received IAsp (n = 157) or HI (n = 165).

How the Study Was Run

The design is described as randomized, open-label, multicenter and parallel-group.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Being open-label, the Insulin Aspart study did not mask who received what.

More than one site took part, so the participants came from several places.

Groups ran in parallel: each of the participants stayed in one arm throughout.

This was a randomized, parallel, open-label, controlled, multicenter, multinational study.

What Was Measured

PubMed files the paper under topics including Denmark, Diabetes Mellitus, Type 1, Diabetes, Gestational, Glycated Hemoglobin, Hypoglycemic Agents, Insulin and Insulin Aspart.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Insulin Aspart.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2008 (American journal of obstetrics and gynecology), a journal based in United States.

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