Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

Primary Objective: \- To assess the safety of SAR341402 and NovoLog® when used in external insulin pumps in terms of the number of patients with infusion set occlusions.

Secondary Objectives: * To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of unexplained hyperglycemia. * To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of: * Intervals for infusion set changes. * Number of patients with insulin pump for "non-delivery" alarm. * Patient observation of infusion set occlusion. * Adverse events and serious adverse events. * Number of patients with hypoglycemic events \[according to ADA (American Diabetes Association) Workgroup on hypoglycemia\].

It had two arms (groups): SAR341402/NovoLog (experimental) and NovoLog/SAR341402 (experimental).

The registry classes the interventions as drug.

More on the Plan

The study duration for each patient will be approximately 10 weeks, including a 2-week screening period, 2 treatment periods of 4 weeks each, and 1-day post-treatment safety follow-up period.

Who Took Part

The registry lists 45 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: Male and female patients with Type 1 diabetes mellitus (T1DM). Age greater than or equal to 18 at the screening visit. Diabetes diagnosed at least 12 months before screening visit. At least 1 year of insulin treatment with at least 6 months of CSII (Continuous Subcutaneous Insulin Infusion) treatment with an external insulin pump. Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for T1DM patients.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: diabetes other than t1dm; history of infection 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 visit.

How the Study Was Run

Design: randomized, crossover and open-label.

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

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

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

It started in 2018-05-10 with completion listed for 2018-10-06.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Infusion set occlusions (time frame: At week 4 from baseline of each treatment).

It also tracked 6 secondary outcomes, for example Unexplained hyperglycemia, Intervals for infusion set changes, Number of patients with insulin pump alarms for "non-delivery", Patient observation of infusion set occlusion, Adverse events and serious adverse events and Number of patients with hypoglycemic events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 45 people.

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

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