iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Lixisenatide.

Study details included: * Study duration per participant: approximately up to 27 weeks * Treatment duration: 24 weeks * Visit frequency: after screening (an on-site visit), on-site or phone call visit every 1 week from randomization till Week 4, every 2 weeks till week 12 and then every 3 weeks till Week 24 (End of Treatment).

There were 14 visits that included 7 phone calls and 7 on-site visits in total during screening and treatment periods.

It had two arms (groups): iGlarLixi (experimental) and IDegAsp (active comparator).

The registry classes the interventions as drug.

Who Took Part

582 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: Participant had at least 18 of age inclusive, at the time of signing the informed consent. Participants who were diagnosed with T2DM for at least 1 year before the screening visit. HbA1c at screening visit:. Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. Body mass index (BMI) \<40 kg/m² at screening.

The full record lists 10 inclusion and 28 exclusion criteria; among the exclusions: pregnant or breast-feeding woman; conditions/situations such as:; participant with short life expectancy.

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.

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

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

It started in 2022-07-07 with completion listed for 2023-10-20.

It ran at 60 sites in China (60).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 18 secondary outcomes, for example Change in Body Weight From Baseline to Week 24, Change in Fasting Plasma Glucose From Baseline to Week 24, Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 24, Percentage of Participants Who Required Rescue Therapy During the 24-Week Treatment Period, Change in Fasting C-Peptide From Baseline to Week 24 and Number of Participants With Any Hypoglycemia Event During On-Treatment Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 582 people.

With 582 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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