NCT05552859

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type 2 Diabetes Mellitus
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Insulin glargine 300 U/mL	Insulin glargine 300 U/mL in the SoloStar pen, self-administered once daily for 24 weeks.
DRUG	Insulin degludec 100 U/mL	Insulin degludec 100 U/mL will be self- administered once daily for 24 weeks.

Timeline

• Start date: 2022-12-05
• Primary completion: 2023-07-28
• Completion: 2023-08-04
• First posted: 2022-09-23
• Last updated: 2025-09-08
• Results posted: 2024-09-05

Locations

68 sites across 5 countries: United States, Czechia, Hungary, Poland, Serbia

Regulatory

• FDA-regulated drug study