Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2

What Was Tested

The trial (phase 1) is built around Lixisenatide.

It had two arms (groups): Sequence 1: AVE0010/Placebo (experimental) and Sequence 2: Placebo/AVE0010 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 22 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin. BMI 25 to 35 kg/m². 155\>=BP systolic \>=90 mmHg. 100\>=BP diastolic\>=45 mmHg.

The full record lists 5 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Because people in this Lixisenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Lixisenatide and the comparison in turn, acting as their own control.

As a double-blind Lixisenatide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2009-06 with completion listed for 2009-08.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the insulin secretion curve (time frame: within 10 minutes after I.V. glucose challenge).

It also tracked 1 secondary outcome, for example Area under the insulin secretion curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Lixisenatide in 22 people.

Its size is small, so on its own it can only give an early look.

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.