Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

What Was Tested

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

It had two arms (groups): Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) (experimental) and GLP-1 Receptor Agonist (active comparator).

The registry classes the interventions as drug.

More on the Plan

The maximum duration for GLP1-RA participants was approximately 29 weeks: up to 2 week screening period, a 26 week treatment period (either randomized or uncontrolled), and a 3 or 9 day post-treatment safety follow-up period.

Maximum duration for FRC participants was approximately 55 weeks: up to 2-week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period.

Who Took Part

514 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 diagnosed at least 1 year prior to screening visit. Signed written informed consent.

The full record lists 8 inclusion and 22 exclusion criteria; among the exclusions: at screening visit, age \<18; any use of antidiabetic drugs within 3 months prior to the screening visit other than those described in the inclusion criteria; laboratory findings at the time of screening, including:.

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 Exenatide and who got the comparison, which limits bias.

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

Being open-label, the Exenatide study did not mask who received what.

It started in 2016-07-06 with completion listed for 2018-05-25.

It ran at 124 sites in United States (74), Spain (10), Romania (9), Slovakia (9), Italy (7) and Israel (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period (time frame: Baseline, Week 26). Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period (time frame: Baseline, Week 52).

It also tracked 16 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period, Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period, Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period, Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period, Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period and Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Glargine in 514 people.

With 514 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 Exenatide compound page and the Insulin Glargine compound page, all human trials.