Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

As people age, their bodies become unable to make enough insulin to control the blood sugars.

It had two arms (groups): Vial & Syringe (Period 1) / Pen (Period 2) (active comparator) and Pen (Period 1) / Vial & Syringe (Period 2) (experimental).

Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.

Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 49 actual participants took part.

It was open to people of any sex aged from 60 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males or females aged ≥60 years. History of type 2 diabetes of \>3 months duration.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: subjects with a known allergy to glargine or any of its metabolites; subjects unwilling to self-inject insulin; inability to self-monitor blood glucose.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-01 with completion listed for 2012-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score (time frame: Baseline, Week 12). Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score (time frame: Week 24).

It also tracked 4 secondary outcomes, for example Hemoglobin A1c (HbA1c), Fasting Blood Glucose and Number of Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 49 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page, all human trials.