drugset / Trial / NCT05552859
Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | insulin degludec | Protein / enzyme biologic | — | — |
| Subject | insulin glargine | Protein / enzyme biologic | — | — |