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

About the trial

Sponsor

Sanofi

Tested

Insulin glargine/Lixisenatide (drug)

Dates

Started 2022-01-27; completion 2023-04-14

Results posted

Yes

The purpose of the study was to demonstrate if iGlarLixi (Soliqua 100/33) would improve glycemic control (as measured by Time in Range) and glycemic variability in participants with very uncontrolled (HbA1c ≥ 9%) type 2 Diabetes Mellitus (T2DM) while on at least 2 oral antidiabetic drugs \[OADs\] with or without a glucagon-like peptide 1 receptor agonist \[GLP1 RA\]), as measured by continuous glucose monitoring (CGM). 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, op…

From ClinicalTrials.gov, last updated 2025-09-09. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi-aventis U.S. LLC reported $3,750 in research payments for this study in 2025 (3 payments).

Products named: Adlyxin

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.