Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period.

The maximum study duration will then be 28 weeks per participant and a 1-day safety follow-up.

Who Took Part

Enrollment: 505 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: Signed 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 t2dm; pregnancy and lactation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2015-01 with completion listed for 2016-02.

It ran at 103 sites in United States (51), Romania (10), Hungary (7), Germany (6), Argentina (5) and Russia (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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 Glucose (PPG) Excursion From Baseline to Week 26, Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia), 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 505 people.

With 505 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.