Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

Note: Lantus insulin is the proprietary name for glargine insulin.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Critical illness causes an impairment of insulin secretion and insulin action, resulting in hyperglycemia even in normal individuals and a worsening of the hyperglycemia in patients with diabetes.

Glucose measurements will be obtained every 1- 4 hours while patients are on their insulin infusions, depending upon the stability of their condition and the stability of their glucose levels.

Following transfer to glargine insulin, they will have glucose measured at least four times per day, premeal and bedtime as per standard protocol in the hospital for patients receiving insulin.

Glucose data will be obtained from such patients and this will be compared among the various glargine regimens.

Who Took Part

The registry lists 75 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patients on surgical services or in intensive care units receiving intravenous insulin.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: inability to obtain informed consent from patient or next-of-kin; allergy to insulin; participation in another research study.

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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2004-07 with completion listed for 2005-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Blood Glucose Values Between 80 - 140 (time frame: First 24 hours after conversion).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 75 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.