Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial

What Was Tested

The paper reports a study of Insulin Glargine and Insulin Aspart, published as a randomized controlled trial.

Who Took Part

According to the abstract, 52 patients were involved.

By PubMed's age tags, the people studied were adults and middle-aged adults, both men and women.

Patients were randomized in a 2:1 ratio to receive either detemir or glargine for 52 weeks.

The basal insulin was initially administered once daily (in the evening) in both groups; if patients in the detemir group were achieving the plasma glucose (PG) target before breakfast but not before dinner, they were switched to twice-daily administration.

How the Study Was Run

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

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

Blinding on both sides kept the patients and researchers unaware of who received Insulin Glargine.

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

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

The timeline in the abstract includes 52 weeks.

Glargine was administered once daily throughout the trial, according to its approved labeling.

Each patient attended 13 study visits and received 16 scheduled telephone calls from the trial site.

What Was Measured

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

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Insulin Glargine and Insulin Aspart in 52 patients over 52 weeks.

Its findings take up roughly 11 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2009 (Clinical therapeutics), a journal based in United States.

More context: the Insulin Glargine compound page and the Insulin Aspart compound page.