Type 2 Diabetes Mellitus Clinical Trial
Official title:
A 16-week, Multicenter, Prospective, Open-label, Single-arm, Phase 4 Study to Evaluate the Effect of Soliqua™ 100/33 on the Percentage of Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Insulin-naïve Patients With Very Uncontrolled Type 2 Diabetes Mellitus
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
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