Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial

What Was Tested

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

The researchers compared stepwise addition of bolus insulin with a full basal-bolus regimen in patients with type 2 diabetes inadequately controlled on basal insulin plus oral antidiabetic drugs.

Who Took Part

According to the abstract, 401 patients were involved.

The age groups tagged for this paper are middle-aged adults and older adults, both men and women.

Patients in the basal-bolus group received insulin aspart before every meal throughout the trial.

How the Study Was Run

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

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Insulin Aspart study: the patients and staff both knew the treatment.

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

This trial is registered with ClinicalTrials.gov, number NCT01165684.

What Was Measured

PubMed files the paper under topics including Blood Glucose, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hypoglycemia, Hypoglycemic Agents, Insulin Aspart and Meals.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Insulin Aspart in 401 patients.

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

The publication is from 2014 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Insulin Aspart compound page.