Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

What Was Tested

In this phase 4 trial, researchers set out to test Lixisenatide.

Primary Objective: To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).

Secondary Objectives: * To assess effect of lixisenatide versus SU on: * Changes in glycemic control; * Changes in body weight. * To assess overall safety of lixisenatide and SU.

It had two arms (groups): Lyxumia (experimental) and Sulfonylurea (active comparator).

Patients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.

Patients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.

The registry classes the interventions as drug.

More on the Plan

The total study duration per patient will have a minimum 12 weeks and maximum 22 weeks (up to 2 weeks screening period + 8-12 weeks pre-Ramadan period + 29-30 days Ramadan + 0 4 weeks post-Ramadan period).

This is a phase 3b study in Kingdom of Saudi Arabia and Bangladesh (instead of phase 4 for other countries).

Who Took Part

The registry lists 184 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: Patients who express the intention to fast during Ramadan. Signed informed consent.

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: at the time of screening age \< legal age of majority; body mass index (bmi) \<20kg/m\^2; treatment with basal insulin for less than 6 months prior to screening.

How the Study Was Run

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

Because people in this Lixisenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Lixisenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-02-23 with completion listed for 2017-08-04.

It ran at 16 sites in India (12), Israel (2), Kuwait (1) and Turkey (Türkiye) (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤[amount hidden]/dL; [amount hidden]/L).

It also tracked 6 secondary outcomes, for example Mean change in HbA1c and Mean change in body weight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Lixisenatide in 184 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lixisenatide compound page, all human trials.