Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Lixisenatide.

It had two arms (groups): iGlarlixi DAILY (experimental) and iGlarlixi WEEKLY (active comparator).

Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached.

The registry classes the interventions as drug.

More on the Plan

The maximum duration of study per patient is approximately 29 weeks including a 2-week screening, a 26-week randomized active-controlled treatment period, and 3-day post-treatment safety follow-up period.

Who Took Part

The registry lists 265 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: Adult subject ≥ 18 years. Patients with type 2 diabetes mellitus (T2DM) based on Diabetes Canada 2018 Clinical Practice Guidelines criteria and diagnosed at least 6 months prior to the screening visit. Patients treated for at least 6 months on any basal insulin (including but not limited to insulin glargine, Toujeo®, Degludec®, etc.) ± oral anti-diabetic drug (OADs). Body mass index (BMI) between 20 kg/m2 and 40 kg/m2 inclusively.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: history of severe hypoglycemia or hypoglycemia unawareness; history of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening visit; current or previous (known intolerance to glp-1s) treatment with glucagon like peptide-1 (glp-1) receptor agonist.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-03-11 with completion listed for 2020-10-23.

It ran at 32 sites in Canada (32).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in glycated hemoglobin (HbA1c)% (time frame: Baseline to Week 26).

It also tracked 15 secondary outcomes, for example Change in fasting plasma glucose (FPG) from baseline to Week 12, Change in FPG from baseline to Week 26, Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12, Change in fasting SMPG from baseline to Week 26, Change in 7-point SMPG profile from baseline to Week 12 and Change in 7-point SMPG profile from baseline to Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 265 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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