Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

What Was Tested

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

Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30.

It had three arms (groups): Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) (experimental), Insulin Glargine (active comparator) and Lixisenatide (active comparator).

The registry classes the interventions as drug.

More on the Plan

Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days follow-up period.

Who Took Part

1170 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 22 exclusion criteria; among the exclusions: hba1c at screening visit:; use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening; previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician).

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2014-02 with completion listed for 2015-06.

It ran at 273 sites in United States (118), Czechia (13), Russia (13), Chile (11), Spain (11) and Hungary (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c From Baseline to Week 30 (time frame: Baseline, Week 30).

It also tracked 14 secondary outcomes, for example Change in Plasma Glucose Excursion From Baseline to Week 30, Change in Body Weight From Baseline to Week 30, Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30, Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30, Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30 and Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 1170 people.

With 1170 participants it is a large trial for this field.

The trial is marked completed; 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.