Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

It is not known; however, what is the best insulin regimen in hospitalized patients.

It had two arms (groups): sliding scale regular insulin (active comparator) and glargine insulin and glulisine insulin (active comparator).

Sliding scale insulin given acqhs.

Glargine basal insulin once a day with prandial glulisine insulin tid.

The registry classes the interventions as drug.

More on the Plan

This study will compare how well regular insulin will compare to glargine (Lantus®) once daily plus glulisine (Apidra®) insulin before meals in hospitalized patients with type 2 diabetes and elevated blood glucose (sugar) levels.

Lantus is a long-acting insulin which is given subcutaneously (under the skin) once daily.

Apidra is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals.

Regular insulin is a short-acting insulin in clinical use for more than 20 years that is also given subcutaneously several times per day.

Who Took Part

The registry lists 130 actual participants took part.

It was open to women only aged from 18 years up to 70 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 70 years admitted to a general medicine service. 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 3 inclusion and 7 exclusion criteria; among the exclusions: subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria \[57\]; mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; female subjects are pregnant or breast feeding at time of enrollment into the study.

How the Study Was Run

Design: 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.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2005-09 with completion listed for 2006-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): blood glucose control (time frame: During hospitalization).

It also tracked 4 secondary outcomes, for example frequency of hypoglycemia, length of hospital stay and inflammatory markers.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 130 people.

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

More context: the Insulin Glargine compound page, all human trials.