Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

What Was Tested

In this phase 2 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

Approximately 27 weeks including a 24-week treatment period.

Who Took Part

Enrollment: 323 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 for at least 1 year.

The full record lists 2 inclusion and 17 exclusion criteria; among the exclusions: age \< legal age of adulthood (18 years); type 1 diabetes mellitus; treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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 2011-11 with completion listed for 2012-12.

It ran at 70 sites in United States (14), Poland (7), Hungary (6), Romania (6), Slovakia (6) and Chile (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline to Week 24 (time frame: Baseline, Week 24).

It also tracked 13 secondary outcomes, for example Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24, Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24, Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24, Change in Body Weight From Baseline to Week 24, Change in FPG From Baseline to Week 24 and Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine and Lixisenatide in 323 people.

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.