Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment — TRENT  

Type 2 Diabetes Mellitus Clinical Trial

Official title: A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment: TRENT Trial

Status Terminated

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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Impairment
• Renal Insufficiency
• Type 2 Diabetes Mellitus

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