Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Lispro.

Primary Objective: * Assess the safety of SAR342434 and Humalog when used in external pumps.

Secondary Objectives: * Intervals for infusion set changes. * Incidence of insulin pump alarms for infusion set occlusion. * Patient observation of infusion set occlusion. * Adverse events including bruising at the infusion site and injection site reactions.

It had two arms (groups): SAR342434/Humalog (experimental) and Humalog/SAR342434 (experimental).

The registry classes the interventions as drug.

More on the Plan

The study duration for each patient will be approximately 10 weeks.

Who Took Part

The registry lists 27 actual participants took part.

It was open to people of any sex aged from 19 years with no upper age limit.

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

Examples of who could join: Male and female subjects above the age of 18. Patients with type 1 diabetes mellitus for at least 1 year prior to the screening visit. At least 1 year of insulin treatment with at least 6 months of continuous subcutaneous insulin infusion (CSII) treatment with an external insulin pump. Signed written informed consent.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: diabetes other than type 1 diabetes mellitus; history of abscess at the infusion site within 3 months prior to the screening visit (visit 1); use of oral glucose-lowering agents or any injectable glucose-lowering agents other than insulin during the 3 months before screening.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.

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

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

It started in 2015-11 with completion listed for 2016-04.

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

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Frequency of infusion set occlusions (time frame: 4 weeks).

It also tracked 3 secondary outcomes, for example Number of infusion set changes in each treatment period, Number of insulin pump alarms for infusion set occlusions and Number of adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 27 people.

Its size is small, so on its own it can only give an early look.

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

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