Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

What Was Tested

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

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

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

IGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks.

Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period.

Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period.

The registry classes the interventions as drug.

More on the Plan

The maximum study duration per patient will be approximately 31 weeks: an up-to 6-week screening and run-in period (with an up-to 2-week screening phase and a 4-week run-in phase), followed by a 24-week randomized treatment period and a 3-day post-treatment safety follow up period.

Who Took Part

The registry lists 878 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: Signed written informed consent.

The full record lists 2 inclusion and 32 exclusion criteria; among the exclusions: age \< legal age of majority at the screening visit (v1); body mass index (bmi) \>40 kg/m² at screening; glycated hemoglobin a1c (hba1c) at screening visit:.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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 2019-02-15 with completion listed for 2021-03-01.

It ran at 79 sites in China (59), South Korea (11), Malaysia (6) and Taiwan (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: From Baseline to Week 24).

It also tracked 11 secondary outcomes, for example Change in postprandial plasma glucose (PPG), Change in fasting plasma glucose (FPG), Change in self-monitored plasma glucose (SMPG) profile, Change in body weight, Confirmed hypoglycemia and Adverse events (AEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 878 people.

With 878 participants it is a large trial for this field.

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.