LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.

What Was Tested

The trial (phase 3) is built around Liraglutide.

The trial is conducted in Asia, Europe, North America and South America.

It had two arms (groups): liraglutide + SGLT2i ± metformin (experimental) and liraglutide placebo + SGLT2i ± metformin (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 303 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: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, age 18 years or older at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus. Body mass index of 20 kg/m\^2 or above.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: history of diabetic ketoacidosis while being treated with sglt2 inhibitors; family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. family is defined as a first degree relative; history or presence of pancreatitis (acute or chronic).

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2017-03-03 with completion listed for 2018-05-04.

It ran at 82 sites in United States (56), India (9), Russia (5), Israel (4), United Arab Emirates (4) and Brazil (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: Week 0, Week 26).

It also tracked 25 secondary outcomes, for example Change in Body Weight, Change in Fasting Plasma Glucose, Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile, Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals), Change in Body Mass Index (BMI) and Number of Treatment Emergent Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 303 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.