Patient-reported outcomes in transition from high-dose U-100 insulin to human regular U-500 insulin in severely insulin-resistant patients with type 2 diabetes: analysis of a randomized clinical trial

What Was Tested

This randomized controlled trial paper looks at Insulin (regular human) in the context of insulin resistance, prediabetes & type 2 diabetes.

The objective of this analysis was to compare patient-reported outcomes between U-500R TID and BID treatment groups in this titration-to-target randomized, clinical trial.

Why It Was Studied

These secondary analyses are based on the study first received January 22, 2013 and reported in Clinical Trial Registry No.: NCT01774968 .

Who Took Part

According to the abstract, 325 patients were involved.

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

In this 24-week, open-label, parallel trial, 325 patients were randomized to TID (n = 162) or BID (n = 163) U-500R after a 4-week lead-in period (screening).

The Treatment Related Impact Measure-Diabetes (TRIM-D) and EQ-5D-5L questionnaires were administered at screening, baseline/randomization, and endpoint (24 weeks).

How the Study Was Run

The researchers set it up as a randomized, open-label and parallel-group study.

Because people in this Insulin (regular human) 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 (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

The methods mention a period of 4 weeks.

The Visual Analog Scale-Injection Site Pain (VAS-ISP) was assessed at baseline/randomization, 12 weeks, and endpoint.

What Was Measured

These secondary analyses are based on the study first received January 22, 2013 and reported in Clinical Trial Registry No.: NCT01774968 .

The subject headings attached to it are Diabetes Mellitus, Type 2, Hypoglycemic Agents, Insulin Resistance, Insulin, Regular, Human, Medication Adherence, Patient Reported Outcome Measures and Quality of Life.

The authors tagged it with the keywords Patient compliance, Patient-reported outcomes, Severe insulin resistance, Type 2 diabetes mellitus and U-500R.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Insulin (regular human) in 325 patients in people with insulin resistance, prediabetes & type 2 diabetes over 4 weeks.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2016 (Health and quality of life outcomes), a journal based in England.

More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.