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

  • STATUS
    Not Recruiting
  • days left to enroll
    71
  • participants needed
    72
  • sponsor
    Sanofi
Updated on 27 January 2023
insulin
type 2 diabetes mellitus
hemoglobin a1c
antidiabetic agents
continuous glucose monitoring

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

Details
Condition Type 2 Diabetes Mellitus
Treatment Insulin glargine/Lixisenatide
Clinical Study IdentifierNCT05114590
SponsorSanofi
Last Modified on27 January 2023

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