Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

What Was Tested

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

Primary Objective: The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan.

Secondary Objective: To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on: * HbA1c; * Fasting plasma glucose; * Body weight.

It had four arms (groups): Lixisenatide + Biguanide (experimental), Lixisenatide + TZD (experimental), Lixisenatide + alpha-GI (experimental) and Lixisenatide + Glinide (experimental).

The registry classes the interventions as drug.

Who Took Part

294 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients with type 2 diabetes mellitus diagnosed at least 1 year before the screening visit. A biguanide (metformin hydrochloride);. A thiazolidinedione (TZD) (pioglitazone hydrochloride);. An alpha-glucosidase inhibitor (alpha-GI) (acarbose, voglibose or miglitol);. Or a glinide (nateglinide, repaglinide or mitiglinide);.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: type 1 diabetes mellitus;; pregnancy or lactation;; laboratory findings at the time of screening:.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Lixisenatide group and the comparison group ran side by side rather than switching.

Everyone knew when Lixisenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-09 with completion listed for 2015-07.

It ran at 27 sites in Japan (27).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data (time frame: 52 weeks).

It also tracked 3 secondary outcomes, for example Absolute change in HbA1c, Absolute change in fasting plasma glucose and Absolute change in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Lixisenatide in 294 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.