Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study

What Was Tested

This randomized controlled trial paper looks at Insulin Aspart and Insulin Detemir.

Who Took Part

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

This randomized, controlled, parallel-group, open-label, 48-week trial compared the stepwise addition of insulin aspart to either the largest meal (titration based on premeal glucose values [SimpleSTEP]) or to the meal with the largest prandial glucose increment (titration based on postmeal glucose values [ExtraSTEP]) in patients with type 2 diabetes inadequately controlled on basal insulin and oral antidiabetes drugs.

How the Study Was Run

The researchers set it up as 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.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Endpoints included hemoglobin A1c (primary endpoint), fasting plasma glucose, self-measured plasma glucose, adverse events, and hypoglycemia.

What Was Measured

The subject headings attached to it are Diabetes Mellitus, Type 2, Hypoglycemic Agents, Insulin Detemir, Insulin, Long-Acting and Insulin, Short-Acting.

What This Means in Plain Language

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

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2011 (Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists), a journal based in United States.

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