Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human) and Insulin Glargine.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Glargine once daily plus glulisine given before meals plus supplemental glulisine for BG \> 140.

Sliding scale regular insulin four-times daily achs.

The registry classes the interventions as drug.

Who Took Part

234 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: Males or females between the ages of 18 and 80 years admitted to a general surgery service. Patients admitted for non-cardiac elective or emergency surgery or trauma. A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria; acute critical illness or cabg surgery expected to require prolonged admission to a critical care unit (icu, ccu, sicu, neuro icu); mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2007-12 with completion listed for 2009-12.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Blood Glucose Concentration (time frame: hospital stay days 2-10).

It also tracked 1 secondary outcome, for example # Participants With Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Glargine in 234 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.