A randomized, open-label, multicentre, parallel-controlled study comparing the efficacy and safety of biphasic insulin aspart 30 plus metformin with biphasic insulin aspart 30 monotherapy for type 2 diabetes patients inadequately controlled with oral antidiabetic drugs: The merit study

What Was Tested

This randomized controlled trial paper looks at Insulin Aspart and NPH Insulin (isophane).

Who Took Part

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

How the Study Was Run

In design terms this was a randomized, open-label, multicenter 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.

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.

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

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

Changes in HbA1c % from baseline to week 16 as well as secondary and safety endpoints were assessed.

What Was Measured

Topics PubMed links to this paper include Biphasic Insulins, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hypoglycemia, Hypoglycemic Agents, Insulin Aspart and Insulin, Isophane.

Author keywords: antidiabetic drug, clinical trial, insulin therapy, metformin and type 2 diabetes.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Insulin Aspart and NPH Insulin (isophane).

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2018 (Diabetes, obesity & metabolism), a journal based in England.

More context: the Insulin Aspart compound page and the NPH Insulin (isophane) compound page, all human trials.