Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Lixisenatide.

It had two arms (groups): Soliqua 100/33 (experimental) and Lantus (active comparator).

Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.

Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.

The registry classes the interventions as drug.

More on the Plan

The study duration was approximately 29 weeks including 2 weeks screening period, 26 weeks open label treatment period, and a 3 days follow-up period.

Who Took Part

The registry lists 241 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: Participants with type 2 diabetes mellitus (T2DM) diagnosed at least 1 year prior to the screening visit (signing of informed consent). The basal insulin regimen (ie, type of insulin and time/frequency of the injection) had been stable for at least 3 months prior to Visit 1.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: age \<18 years of age at visit 1; A body mass index (BMI) \<=20 or \>40 kg/m\^2 at Visit 1; type 1 dm or any diabetes other than t2dm.

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 2018-02-20 with completion listed for 2019-01-07.

It ran at 85 sites in United States (85).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 6 secondary outcomes, for example Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26, Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26 and Change From Baseline in Body Weight at Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 241 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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