Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

What Was Tested

The trial (phase 4) is built around Insulin Glargine and Lixisenatide.

It had two arms (groups): Lixisenatide (experimental) and Sitagliptin - Januvia (active comparator).

The registry classes the interventions as drug.

More on the Plan

The duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances. 13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).

Who Took Part

Enrollment: 136 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

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

Examples of who could join: Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis. Aged 20-75 years.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: type 1 diabetes mellitus; pregnancy or lactation; hypersensitivity to lixisenatide.

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.

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

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 2014-08 with completion listed for 2015-11.

It ran at 20 sites in Japan (20).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast (time frame: Day 29 after first intake of investigational product).

It also tracked 5 secondary outcomes, for example Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast, Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast, Change from baseline in glucagon levels at Day 29 after a standardized breakfast, Change in gastric emptying half life (13C-acetic acid breath test) and Proportion of patients with adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Lixisenatide in 136 people.

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

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