Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-06-30 @ 7:25 PM
Study NCT ID:
NCT05552859
Status:
TERMINATED
Last Update Posted:
2025-09-08
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to cancel trial due to poor recruitment/ severe recruitment delay and not related to safety concern.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRENT
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-001485-35 | EUDRACT_NUMBER | None | View |