Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes

What Was Tested

This randomized controlled trial paper looks at Insulin Aspart.

Who Took Part

According to the abstract, 394 patients were involved.

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

A multinational, randomised, open-label parallel-group trial in 394 patients with type 2 diabetes on a once or twice daily insulin regimen.

Patients were randomised 1:1 to BIAsp or IAsp+NPH for 16 weeks.

How the Study Was Run

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

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

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 timeline in the abstract includes 16 weeks.

The BIAsp group was treated according to individual needs using BMI as a surrogate index of insulin resistance.

Subjects administered BIAsp 70 (BMI< or =30 kg/m (2)) or BIAsp 50 (BMI>30 kg/m (2)) with breakfast and lunch and BIAsp 30 with dinner.

The IAsp+NPH group injected IAsp at meals and NPH at bedtime as basal insulin.

The incidence of hypoglycaemic episodes and adverse events was evaluated.

What Was Measured

Topics PubMed links to this paper include Biphasic Insulins, Blood Glucose, Diabetes Mellitus, Type 2, Drug Administration Routes, Hypoglycemia, Hypoglycemic Agents and Injections.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Insulin Aspart in 394 patients over 16 weeks.

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 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2006 (Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association), a journal based in Germany.

More context: the Insulin Aspart compound page.