Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine

What Was Tested

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

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

SAR341402 subcutaneous (SC), before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.

NovoLog/NovoRapid SC, 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 2-week screening period, a 26-week treatment period, a 26-week comparative safety extension period, and a 1-day follow-up period.

The maximum study duration was 54 weeks per participant and a 1 day safety follow-up.

Who Took Part

The registry lists 597 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.

The full record lists 3 inclusion and 20 exclusion criteria; among the exclusions: at screening visit, age under legal age of adulthood; less than 1 year on continuous insulin treatment; use of insulin pump in the last 3 months before screening visit.

How the Study Was Run

The set-up was 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 2017-08-02 with completion listed for 2018-07-16.

It ran at 82 sites in United States (42), Hungary (10), Japan (10), Poland (7), Germany (5) and Finland (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 (time frame: Baseline, Week 26).

It also tracked 11 secondary outcomes, for example Change in HbA1c From Baseline to Week 52, Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52, Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52, Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52, Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point and Number of Participants With at Least One Hypoglycemic Event.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 597 people.

With 597 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 Aspart compound page, all human trials.