Basal insulin analogues in diabetic pregnancy: a literature review and baseline results of a randomised, controlled trial in type 1 diabetes

What Was Tested

The paper reports a study of Insulin Aspart and NPH Insulin (isophane), published as a randomized controlled trial.

The aim of this review is to provide an overview of the current literature concerning basal insulin analogue use in diabetic pregnancy, and to present the design and preliminary, non-validated baseline characteristics of a currently ongoing randomized, controlled, open-label, multicentre, multinational trial comparing insulin detemir with neutral protamine hagedorn insulin, both with insulin aspart, in women with type 1 diabetes planning a pregnancy (n = 306) or are already pregnant (n = 164).

Why It Was Studied

Exclusion criteria include impaired hepatic function, cardiac problems, and uncontrolled hypertension.

Who Took Part

PubMed tags the participants as women only.

How the Study Was Run

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

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.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Hypoglycemia, 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 and NPH Insulin (isophane).

The publication is from 2011 (Diabetes/metabolism research and reviews), a journal based in England.

More context: the Insulin Aspart compound page and the NPH Insulin (isophane) compound page.