Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.

Who Took Part

The registry lists 736 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: Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit. Treatment with basal insulin for at least 6 months before the screening visit. Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit. A dipeptidyl-peptidase-4 inhibitor,. A sodium glucose co-transporter 2 inhibitor,.

The full record lists 12 inclusion and 22 exclusion criteria; among the exclusions: age under legal age of adulthood at screening visit; use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening; participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide frc or had previously received lixisenatide.

How the Study Was Run

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

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.

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 2014-01 with completion listed for 2015-07.

It ran at 236 sites in United States (108), Russia (13), Canada (11), Czechia (11), Romania (11) and Slovakia (11).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 14 secondary outcomes, for example Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30, Change in Body Weight From Baseline to Week 30, Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30, Change in FPG From Baseline to Week 30, Change in 2-hour 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 736 people.

With 736 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.