Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Lixisenatide.

The total study duration per participant was approximately 22 weeks.

Three site visits, 3 site or home visits, and up to 13 phone contacts were scheduled. * A screening period of up to 2 weeks * A run-in period of up to 2 weeks, including the baseline period * A 16-week, open-label treatment period * A 2-week post-treatment safety follow-up period.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 124 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: Diagnosed with Type 2 Diabetes mellitus (T2DM) for at least 6 months before the baseline period. Willing and able to prick fingers a minimum of 2-4 times per week utilizing sterile lancets provided along with a manual blood glucose meter kit. Willing to discontinue the daily (oral or injectable) or weekly GLP-1 RA or DPP 4i prior to administration of iGlarLixi (Soliqua 100/33).

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: type1 diabetes mellitus (t1dm) or any other types of diabetes, except t2dm; on meglitinides (eg, nateglinide, repaglinide); body mass index (bmi) \>40 kg/m² during the screening period.

How the Study Was Run

The set-up was single-group and open-label.

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

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

It started in 2022-01-27 with completion listed for 2023-03-28.

It ran at 18 sites in United States (18).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV), Change From Baseline to Week 16 in Mean Daily Blood Glucose, Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal, Change From Baseline to Week 16 in Time in Range Per Time Blocks, Change From Baseline to Week 16 in the 4-Hour Postprandial Glucose Area Under the Concentration Time Curve From 0 to 4 Hours and Change From Baseline to Week 16 in Time to Reach Maximum Postprandial Glucose Concentration.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine and Lixisenatide in 124 people.

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.