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

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Lixisenatide.

Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 Diabetes.

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

The registry classes the interventions as drug.

More on the Plan

The maximum study duration per patient will be approximately 29 weeks: an up to 2-week screening period, a 26-week randomized open-label treatment period and a 3-day post-treatment safety follow up period.

Who Took Part

Enrollment: 521 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 during the inclusion criteria in 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

The set-up was 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 2016-05-23 with completion listed for 2018-03-12.

It ran at 113 sites in Japan (113).

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 2-hour postprandial glucose (PPG) during standardized meal test, Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test, Change from baseline in body weight, Percentage of patients requiring a rescue therapy, Number of adverse events and Number of hypoglycemic events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 521 people.

With 521 participants it is a large trial for this field.

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.