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Clinical Trial Summary

The TRENT trial is designed to confirm the efficacy and safety of Gla-300 compared with IDeg-100 in insulin-naïve patient (participants who have not tried insulin) with Type 2 Diabetes Mellitus (T2DM) and renal impairment. It will test the hypothesis that Gla-300 is non-inferior to IDeg-100 with glucose control. If achieved, the trial will also test for the superiority of Gla-300 compared with IDeg-100 in Hemoglobin A1c (HbA1c) reduction, without an increased potential risk of hypoglycemia.


Clinical Trial Description

The trial will consist of the following periods: - A screening period of up to 2 weeks, - A 24-week, open-label treatment period, including a titration period and a maintenance period. - A 7-day, post-treatment, safety follow-up period after the last dose of the study drug or after premature/permanent discontinuation from study drug treatment. This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05552859
Study type Interventional
Source Sanofi
Contact
Status Terminated
Phase Phase 4
Start date December 5, 2022
Completion date August 4, 2023

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