Insulin Therapy in the Hospital Comparing Two Protocols

What Was Tested

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

The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 planned participants were the target.

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: Uncontrolled blood sugar:. Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours. Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward. Patient is able to eat and oral feeding is expected.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: patients receiving inpatient oral hypoglycemic agents; patient with chronic liver disease; patient with hypoglycemia unawareness.

How the Study Was Run

Design: 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 2006-12 with completion listed for 2009-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The rate of correct timing of insulin and food administration. Pre and post- prandial glucose levels.

It also tracked 4 secondary outcomes, for example Length of hospital stay, Nursing staff satisfaction scores for evaluation of the two methods and Hypoglycemia rates.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 60 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 and the Insulin Lispro compound page, all human trials.