Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

What Was Tested

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

It had three arms (groups): Lixisenatide (experimental), Insulin Glulisine QD (active comparator) and Insulin Glulisine TID (active comparator).

Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.

Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.

The registry classes the interventions as drug.

More on the Plan

Approximately 41 weeks including a 26 week treatment period.

Who Took Part

Enrollment: 894 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 before screening visit (V1). Participants treated with basal insulin for at least 6 months.

The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: at screening: age \< legal age of majority; type 1 diabetes mellitus; treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months 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.

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 2013-01 with completion listed for 2014-12.

It ran at 199 sites in United States (46), Canada (18), Romania (17), Germany (13), United Kingdom (12) and Mexico (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline to Week 26 (time frame: Baseline, Week 26). Change in Body Weight From Baseline to Week 26 (time frame: Baseline, Week 26).

It also tracked 13 secondary outcomes, for example Percentage of Participants With no Weight Gain at Week 26, Change in Average 7-point SMPG Profiles From Baseline to Week 26, Change in FPG From Baseline to Week 26, Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast), Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast) and Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 894 people.

With 894 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.