drugset / Trial / NCT05552859

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

NCT05552859

Phase 4 Terminated 62 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-12-05
Primary completion
2023-07-28
Completion
2023-08-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator insulin degludec Protein / enzyme biologic
Subject insulin glargine Protein / enzyme biologic