Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

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 mellitus.

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 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.

Who Took Part

The registry lists 513 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: Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit (V1). Patient treated with a stable, once a day basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. Dipeptidyl-peptidase-4 (DPP-4) inhibitor;. Sodium glucose co-transporter 2 (SGLT2) inhibitor;. Alpha glucosidase inhibitor (alpha-GI).

The full record lists 11 inclusion and 24 exclusion criteria; among the exclusions: age \<20 years at screening visit; use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening visit; previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin.

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.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2016-05-17 with completion listed for 2018-10-04.

It ran at 122 sites in Japan (122).

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 15 secondary outcomes, for example Change from baseline in 2-hour postprandial plasma glucose (PPG) during standardized meal test, Change from baseline in blood glucose excursion during standardized meal test, Change from baseline in 7-point self-monitoring plasma glucose (SMPG) profiles (each time point and average daily value), Change from baseline in body weight, Change from baseline in FPG and Percentage of patients requiring a rescue therapy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 513 people.

With 513 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.