Simplified Insulin Protocol Using Lantus in Elderly

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

It had 1 arm (groups): Glargine (experimental).

The researchers plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.

The registry classes the interventions as drug.

More on the Plan

This may lead to errors in treatment and poor glucose control.

In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months).

The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.

Who Took Part

65 actual participants took part.

It was open to people of any sex aged from 70 years with no upper age limit.

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

Examples of who could join: Age 70 years or older. At least 2 (short-acting or mixed) insulin injections per day. At least 1 episode of hypoglycemia (glucose value \<70) on screening CGM.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: patients with the following illnesses in the past 12 months myocardial infarction angina coronary artery bypass grafting percutaneous transluminal coronary angiography cerebrovascular event (stroke, tia); active liver disease (history of cirrhosis or lft \> 3 times normal); malignancy that limits life span to less than 18 months.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Insulin Glargine study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-06 with completion listed for 2015-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Duration of Hypoglycemia Episodes (time frame: baseline, 5 months, 8 months). Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months (time frame: baseline, 5 months, 8 months).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine in 65 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.