Perioperative Insulin Glargine Dosing Study

What Was Tested

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

It had three arms (groups): 1 (experimental), 2 (active comparator) and 3 (experimental).

The registry classes the interventions as drug and other.

More on the Plan

Insulin glargine provides peakless 24-hour coverage of basal insulin needs for people with both Type 1 and Type 2 diabetes.

Insulin glargine may be used as the sole insulin or in combination with other rapid-acting insulin to achieve glycemic control.

Symptoms of low blood sugar are undetectable in anesthetized patients, and blood glucose is tested at least hourly.

Frequently insulin glargine is administered in the evening.

Who Took Part

402 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Scheduled for Surgical Procedure. Self Management of Diabetes. Currently on Evening Insulin Glargine prescribed by Primary Care Physician. Age 18 or over. Able to Communicate Clearly over the Phone.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: on glucocorticoid medication; history of hypoglycemia unawareness; pregnancy or lactating female.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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

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.

It started in 2005-10 with completion listed for 2008-10.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery (time frame: Day 1).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Glargine in 402 people.

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

More context: the Insulin (regular human) compound page and the Insulin Glargine compound page, all human trials.