A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 2) is built around Liraglutide.

It had five arms (groups): Placebo (placebo comparator), one (experimental), one (experimental), one (experimental) and Liraglutide (active comparator).

The registry classes the interventions as drug.

More on the Plan

The total study duration will be approximately 30 weeks, consisting of 3 weeks screening period at the site, a 26 weeks treatment period, and 3 days post treatment follow up period.

Who Took Part

Enrollment: 296 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Participants with type-2 diabetes mellitus (T2DM) for at least 3 months before the screening visit. Signed informed consent.

The full record lists 3 inclusion and 19 exclusion criteria; among the exclusions: at screening, participant's age \< legal age of adulthood and \>80 years; body mass index (bmi) \<25 kg/m\^2 or \>45.0 kg/m\^2; pregnant or lactating women.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

The Liraglutide group and the comparison group ran side by side rather than switching.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-12-02 with completion listed for 2017-12-27.

It ran at 59 sites in United States (23), Spain (8), Hungary (6), Canada (5), Mexico (5) and Russia (5).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 9 secondary outcomes, for example Mean Change From Baseline in Body Weight to Week 26, Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26, Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26, Percentage of Participants Requiring Rescue Therapy, Change From Baseline in Beta-Cell Function to Week 26 and Change From Baseline in Insulin Resistance to Week 26.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 296 people.

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

More context: the Liraglutide compound page, all human trials.