Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

Secondary Objectives: To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study.

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

SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.

Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.

The registry classes the interventions as drug.

More on the Plan

The study consisted of a: * Up to 2 weeks screening period * 26-week treatment period * 26-week comparative safety extension period * 1-day follow-up period * The maximum study duration would be 54 weeks per participant and a 1-day safety follow-up.

Who Took Part

507 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: Written informed consent.

The full record lists 2 inclusion and 13 exclusion criteria; among the exclusions: at screening visit, age under legal age of adulthood; diabetes other than t1dm; status post pancreatectomy.

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.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2014-10 with completion listed for 2015-12.

It ran at 89 sites in United States (47), Germany (8), Hungary (7), Russia (7), Japan (6) and Poland (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline to Week 26 (time frame: Baseline, Week 26).

It also tracked 7 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26, Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26, Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26, Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year, Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions and Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 507 people.

With 507 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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