Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin

What Was Tested

This registered phase 3 trial tested Insulin (regular human) and Insulin Glargine.

The purpose of this study is to compare the use of insulin glargine plus insulin lispro to human regular insulin for treatment of hyperglycemia in the hospital setting in patients without known prior history of diabetes.

It had two arms (groups): Sliding scale regular insulin (active comparator) and Basal-bolus therapy (experimental).

The registry classes the interventions as drug.

More on the Plan

This study involves a comparison of 2 methods for administering subcutaneous insulin therapy to non-critically ill adult patients with hyperglycemia and without known history of diabetes who are admitted to non-intensive care unit (ICU) general medical hospital services.

Basal-bolus therapy, considered the gold standard for glucose control in patients with known diabetes, will be compared with sliding scale insulin, a commonly used method of glucose control (prevailing standard practice) in hospitalized patients.

Who Took Part

The registry lists 16 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: No known history of diabetes. Non-critically ill and admitted to acute care medical services. Have a body mass index greater than or equal to 18.5 kg/m\^2 and less than or equal to 45 kilograms per square meter (kg/m\^2).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: have taken any oral or injectable antihyperglycemic medications other than insulin within 3 months prior to study entry; expected hospitalization less than 24 hours post-randomization.

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 (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2011-03 with completion listed for 2011-11.

It ran at 12 sites in United States (12).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Plasma Glucose (MPG) Throughout Hospital Study Period (time frame: Throughout hospital study period (1 to 10 days post-randomization)).

It also tracked 26 secondary outcomes, for example Mean Plasma Glucose (MPG) by Hospital Day, Mean Fasting Plasma Glucose (FPG) by Hospital Day, Mean FPG Throughout Hospital Study Period, TDD of Insulin (Units) by Hospital Day, Length of Hospital Stay Post-randomization Throughout the Hospital Study Period and Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Glargine in 16 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 (regular human) compound page and the Insulin Glargine compound page, all human trials.