Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay

What Was Tested

This registered phase 4 trial tested Insulin (regular human) and Insulin Glargine.

Few randomized studies have focused on the optimal management of non-ICU patients with type 2 diabetes in Latin America.

It had two arms (groups): Basal Bolus (Glargine and Glulisine) (experimental) and Human Insulin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Few randomized intervention inpatient trials have been conducted in Latin America to determine optimal treatment regimens for patients with type 2 diabetes.

In the absence of regional guidelines, most international societies in Latin America recommend following international guidelines for the management of hospitalized patients with diabetes.

However, hospital resources, admission cause and inpatient glycemic control differ among countries.

In the US, the leading cause of admission to the hospital in patients with diabetes is cardiovascular disease, whereas infections and acute complications of diabetes are more common than cardiovascular disease in some countries.

Who Took Part

134 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: Age \>18 years. History of type 2 diabetes \> 1 month. Treatment with diet alone, any combination of oral antidiabetic agents, and/or insulin prior to admission. Absence of diabetic ketoacidosis.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: no history of diabetes; subjects expected to undergo surgery during the hospitalization course; clinically relevant hepatic disease.

How the Study Was Run

Design: 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.

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 2009-04 with completion listed for 2010-04.

It ran at 1 site in Paraguay.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glycemic control (time frame: During hospitalization, an expected average of 10 days).

It also tracked 4 secondary outcomes, for example Hypoglycemia, Length of stay and Mortality.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Glargine in 134 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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