Simplified Insulin Regimen for the Elderly

What Was Tested

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

Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment.

However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day.

It had two arms (groups): Multiple Subcutaneous Injection (MSI) (active comparator) and Basal Insulin (BI) (experimental).

MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.

BI group will receive only one injection of insulin glargine in the morning.

The registry classes the interventions as drug.

Who Took Part

The registry lists 7 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

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

Examples of who could join: Age \>65 years.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: unable to provide informed consent; enrollment in another research study; history of hypoglycemia unawareness.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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 2018-10-10 with completion listed for 2022-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hemoglobin A1c (HbA1c) (time frame: 6 months).

It also tracked 2 secondary outcomes, for example Incidence of Any Hypoglycemia and Incidence of Severe Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 7 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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