Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus

What Was Tested

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

Also assessed was patients' preference for pen device--the NovoMix 30 FlexPen /NovoLog Mix 70/30 FlexPen (FlexPen) versus the Humalog Mix25 Pen/Humalog Mix75/25 Pen (Humalog Pen).

Who Took Part

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

Patients with type 2 DM receiving current insulin treatment were randomized to a multinational, multicenter, open-label, 2-period, crossover comparison of BIAsp 30 and Mix25.

Patients' preference for pen device was assessed by questionnaires.

How the Study Was Run

The researchers set it up as a randomized, open-label, crossover and multicenter study.

The participants 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.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Running at several centres spread the Insulin Aspart study over different clinics and patient groups.

What Was Measured

The subject headings attached to it are Biphasic Insulins, Blood Glucose, Diabetes Mellitus, Type 2, Disposable Equipment, Glycemic Index, Hypoglycemic Agents and Insulin.

What This Means in Plain Language

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

Results are reported in around 12 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2004 (Clinical therapeutics), a journal based in United States.

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