Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Lixisenatide.

It had two arms (groups): Tested Drug (experimental) and Control Drug (active comparator).

Insulin glargine/lixisenatide fixed ratio combination (FRC).

Insulin glargine (Lantus®).

The registry classes the interventions as drug.

More on the Plan

The maximum study duration per patient is 33 weeks.

Who Took Part

Enrollment: 247 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit,. Age should be ≥ 18 years of age to \< 65 years;. Body mass index (BMI) ≥ 19 kg/m2 and ≤ 40 kg/m2.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening; for patients taking metformin, any contraindication to metformin use, according to local labeling; personal or immediate family history of medullary thyroid cancer (mtc) or genetic condition that predisposes to mtc (eg, multiple endocrine neoplasia syndromes).

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.

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

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

It started in 2018-06-19 with completion listed for 2019-11-25.

It ran at 13 sites in India (13).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: From baseline to Week 24).

It also tracked 8 secondary outcomes, for example Change in 2-hour Post prandial glucose (PPG), Change in body weight, Change in Fasting Plasma Glucose, Adverse events (AE) and Change in SMPG profiles.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 247 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.