Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

What Was Tested

The trial (phase 3) is built around Lixisenatide.

It had two arms (groups): Lixisenatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up).

Who Took Part

The registry lists 447 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.

The full record lists 0 inclusion and 7 exclusion criteria; among the exclusions: age \< legal age of adulthood; history of hypoglycemia unawareness; body mass index (bmi) ≤20 kg/m².

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

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

Neither the participants nor the staff measuring them knew who was on Lixisenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2012-10 with completion listed for 2015-05.

It ran at 51 sites in China (30), India (10), South Korea (6) and Russia (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: from baseline to week 24).

It also tracked 8 secondary outcomes, for example Change in 2-hour postprandial plasma glucose and plasma glucose excursion, Change in fasting plasma glucose, Change in 7-point self monitoring plasma glucose profile (average and each point), Change in body weight, Number of patients with adverse events and Anti-lixisenatide antibody assessment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lixisenatide in 447 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lixisenatide compound page, all human trials.