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NCT05552859 · ClinicalTrials.gov registry record · Phase 4
Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
A Phase 4 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT05552859: Clinical Trial Phase 4 study, sponsored by Sanofi.
NCT05552859 is a Phase 4 study that was terminated before completion, run by Sanofi. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05552859, a Phase 4 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study 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.
Primary Outcome
Change in HbA1c was calculated by subtracting baseline value from Week 24 value and then mean values were calculated.
Interventions
- DRUG Insulin glargine 300 U/mL
- DRUG Insulin degludec 100 U/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2023-08-04 |
| Phase | Phase 4 |
Why NCT05552859 stopped before completion
NCT05552859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Insulin glargine 300 U/mL is the first listed.
NCT05552859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05552859 about?
NCT05552859 is a clinical study titled "Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment". 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 glu...
What is the current status of trial NCT05552859?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2022-12-05. Estimated completion is 2023-08-04.
What interventions are being tested in trial NCT05552859?
The interventions under investigation include: Insulin glargine 300 U/mL (DRUG), Insulin degludec 100 U/mL (DRUG).
Who is sponsoring clinical trial NCT05552859?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05552859's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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