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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 is a Phase 4 study that was terminated before completion, run by Sanofi. The registered enrollment target is 62 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05552859
The ClinicalTrials.gov registry entry for NCT05552859 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Insulin glargine 300 U/mL is the first listed.
NCT05552859 reports 0 study locations.
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.
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