Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

It had two arms (groups): Insulin glargine+glulisine (experimental) and Split-mixed NPH + Regular insulin (active comparator).

Daily insulin glargine + glulisine before meals.

Split-mixed NPH + Regular insulin twice daily.

The registry classes the interventions as drug.

More on the Plan

Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes.

The mainstay in the treatment of DKA involves the continuous intravenous (IV) infusion of regular insulin or the frequent subcutaneous (SC) injections of regular or rapid-acting insulin analogs.

Multiple studies have reported successful protocols for insulin administration during the acute management of DKA, but they have failed to address the transition phase from IV to SC maintenance insulin regimen.

The American Diabetes Association (ADA) position statement recommends the use of split-mixed insulin combination of regular and intermediate-acting insulin (NPH).

Who Took Part

Enrollment: 74 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.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: hemodynamic instability (map \< 50 or patients requiring pressor).

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

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

It started in 2007-12 with completion listed for 2008-06.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups (time frame: 5 days after transitioning to subcutaneous insulin).

It also tracked 3 secondary outcomes, for example Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin, Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups and Difference in Time in Hours to Resolution of DKA Between the 2 Groups.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 74 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.