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NCT05465317 · ClinicalTrials.gov registry record
Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease
A clinical trial of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- 62,197
- Enrollment target
- 1
- Study location
NCT05465317: Completed study of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
NCT05465317 is a study of Diabetes Mellitus, Type 2 that has completed, run by Boehringer Ingelheim. The registered enrollment target is 62,197 participants, above the 4,307-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (1344% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05465317, a study of Diabetes Mellitus, Type 2, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- 62,197 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP4i) in patients with Type 2 Diabetes Mellitus (T2DM) with and without established kidney disease. The secondary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of any Sodium glucose co-transporter-2 inhibitors (SGLT2i) compared to Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) in patients with T2DM.
Primary Outcome
40% decline in eGFR: at least 2 measurements during follow-up of at least a 40% decline relative to baseline separated by \>= 28 days. the second eGFR measurement is required to be within 2 years from index, at which time, all patients were censored. ESKD: at least 1 kidney transplant or ESKD diagnosis/procedure or at least 2 dialysis diagnoses/procedures separated by \>= 28 days or eGFR\<15 on 2 measurements separated by \>= 28 days. Post-LASSO overlap weighting was used. A LASSO penalized re
Conditions Studied
Interventions
- DRUG Empagliflozin
- DRUG Dipeptidyl Peptidate-4 inhibitors
Study Locations (1)
North Carolina
- Duke Clinical Research Institute - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62,197 participants |
| Start Date | 2022-08-08 |
| Est. Completion | 2023-05-02 |
What the finished NCT05465317 record still lists
NCT05465317 is an observational study that tracks outcomes without assigning an intervention. Its 62,197 participants enrollment target places it among the larger protocols in the corpus, above the 4,307-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (1344% higher).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Empagliflozin is the first listed.
NCT05465317 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05465317 about?
NCT05465317 is a clinical study titled "Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease". The primary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP4i) in patients with Type 2 Diabetes Mellitus (T2DM) with and without established kidney disease. The secondary purpose...
What is the current status of trial NCT05465317?
This trial is currently completed. The enrollment target is 62,197 participants. The study started on 2022-08-08. Estimated completion is 2023-05-02.
What conditions does trial NCT05465317 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT05465317?
The interventions under investigation include: Empagliflozin (DRUG), Dipeptidyl Peptidate-4 inhibitors (DRUG).
Who is sponsoring clinical trial NCT05465317?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05465317 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05465317's enrollment target sits among peer trials
62,197 5th of 348 higher than 344 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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.
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