Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

What Was Tested

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

Primary Objective: To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus.

It had two arms (groups): LixiLan (experimental) and lixisenatide (active comparator).

The registry classes the interventions as drug.

More on the Plan

Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.

Who Took Part

321 actual participants took part.

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

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

Examples of who could join: Signed written informed consent.

The full record lists 2 inclusion and 16 exclusion criteria; among the exclusions: at the screening visit: age \<20 years; use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria during the 3 months before the screening visit; previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2016-05-09 with completion listed for 2018-05.

It ran at 61 sites in Japan (61).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in HbA1c (time frame: Baseline, 26 weeks).

It also tracked 11 secondary outcomes, for example Change from baseline in fasting plasma glucose, Change in from baseline in 7 point self-monitored plasma profiles, Change from baseline in body weight, Percentage of patients requiring a rescue therapy, Number of hypoglycemic events and Number of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 321 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.