A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Lixisenatide.

It had 1 arm (groups): iGlarLixi (experimental).

IGlarLixi will be administered to study participants subcutaneously.

The registry classes the interventions as drug.

More on the Plan

The study duration will be up to 27 weeks, with a treatment duration approximately 24 weeks.

Who Took Part

Enrollment: 105 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Participants must be ≥18 years of age, at the time of signing the informed consent. Participant with BMI \>= 25 kg/m2 (as per Endocrine Society of India, Ref 12). Signed informed consent.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: type 1 diabetes mellitus or any diabetes other than t2dm; prior use of any combination of basal insulin + glp-1 ra fixed ratio or free combination, premix insulin, basal bolus therapy; history of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-01-06 with completion listed for 2026-06-12.

It ran at 10 sites in India (10).

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs) (time frame: From Day 1 to Week 25).

It also tracked 8 secondary outcomes, for example Mean change in hemoglobin A1c (HbA1c), Mean change in fasting plasma glucose (FPG), Mean change in 2 hours postprandial plasma glucose (PPG), Mean change in fasting Self-Monitoring Plasma Glucose (SMPG), Effect of iGlarLixi on 7-point Self-Monitoring Plasma Glucose (SMPG) profile and Mean change in bodyweight.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine and Lixisenatide in 105 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.