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

• Status: Not yet recruiting
• Trial end date: 2022-11-14

Summary

The purpose of the study is to demonstrate if Soliqua 100/33 improves 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 glucagonlike peptide 1 receptor agonist [GLP1 RA]), as measured by continuous glucose monitoring (CGM).

The total study duration per participant will be approximately 22 weeks. Three site visits, 3 site or home visits, and up to 13 phone contacts are scheduled.

• A screening period of up to 2 weeks

• A run-in period of up to 2 weeks and includes the baseline period

• A 16-week, open-label treatment period

• A 2-week post-treatment safety follow-up period

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin Glargine; Lixisenatide