Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

What Was Tested

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

Secondary Objectives: * To assess the effects of iGlarLixi in comparison with insulin glargine * To assess the safety in each treatment group.

It had two arms (groups): Soliqua (insulin glargine/lixisenatide) (experimental) and Lantus (insulin glargine) (active comparator).

IGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks.

Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 426 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: Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and treated with basal insulin for at least 6 months before screening visit (V1). Patients who have been treated with a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before screening visit (V1). Alpha-glucosidase inhibitor (alpha-GI). Sodium-glucose co-transporter 2 (SGLT2) inhibitor. Dipeptidyl-peptidase-4 (DPP-4) inhibitor.

The full record lists 11 inclusion and 27 exclusion criteria; among the exclusions: age \<18 years at screening visit (v1); history of hypoglycemia unawareness; history of metabolic acidosis, including diabetic ketoacidosis within one year prior to screening.

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.

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

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 2019-02-19 with completion listed for 2020-12-01.

It ran at 45 sites in China (45).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: From Baseline to Week 30).

It also tracked 12 secondary outcomes, for example Change in postprandial plasma glucose (PPG), Change in self-monitored plasma glucose (SMPG) profile, Change in body weight, Patients requiring rescue therapy, Change in fasting plasma glucose (FPG) and Confirmed hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 426 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.