A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Lispro.

It had two arms (groups): Humalog U-100 Insulin (active comparator) and LINjeta U-100 (experimental).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The diagnosis of type 1 diabetes is based on the investigator¡-s judgment; C peptide level and antibody determinations are not needed.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: chronic oral steroid use.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Lispro.

Those kept unaware of assignments: participant and investigator.

It started in 2010-04 with completion listed for 2011-01.

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

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal (time frame: 2 weeks). The primary endpoint for this second phase is the 3 hour area under the curve from baseline following a standardized breakfast meal in the outpatient setting (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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