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Die klinische Studie NCT05220917 (CER-4-T2D) für Kardiovaskuläre Ereignisse, Typ-2-Diabetes, Nierenerkrankung ist aktiv, nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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Brigham and Women's KrankenhausComparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study (CER-4-T2D) 781.430 Direkter Vergleich Beobachtend
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Die klinische Studie NCT05220917 (CER-4-T2D) ist eine beobachtungsstudie zur Untersuchung von Kardiovaskuläre Ereignisse, Typ-2-Diabetes, Nierenerkrankung und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 1. August 2021 und soll 781.430 Teilnehmer aufnehmen. Durchgeführt von Brigham and Women's Krankenhaus ist der Abschluss für 1. Juli 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 8. Dezember 2025 aktualisiert.
Kurzbeschreibung
To perform an observational analysis to emulate a target trial (i.e., a hypothetical pragmatic trial that would have answered the causal question of interest) comparing the effectiveness and safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in he...Mehr anzeigen
Ausführliche Beschreibung
Aim 1: (1a.) To evaluate the effectiveness of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in head-to-head comparisons with respect to cardiovascular (CV) events, mortality, renal events, and other patient-centered outcomes (e.g., time spent at home),...Mehr anzeigen
Offizieller Titel
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
Erkrankungen
Kardiovaskuläre EreignisseTyp-2-DiabetesNierenerkrankungWeitere Studien-IDs
- CER-4-T2D
- 2021P001784
NCT-Nummer
Studienbeginn (tatsächlich)
2021-08-01
Zuletzt aktualisiert
2025-12-08
Studienende (vorauss.)
2026-07-01
Geplante Rekrutierung
781.430
Studientyp
Beobachtungsstudie
Status
Aktiv, nicht rekrutierend
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
SGLT-2i (Comparison 1) For SGLT-2i vs. DPP4i SGLT-2i - exposure group DPP4i - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
DPP-4i (Comparison 1) For SGLT-2i vs. DPP4i SGLT-2i - exposure group DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SGLT-2i (Comparison 2) For SGLT-2i vs GLP-1 RA SGLT-2i - exposure group GLP-1 RA - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 2) For SGLT-2i vs GLP-1 RA SGLT-2i - exposure group GLP-1 RA - referent group | GLP-1RA Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 3) For GLP-1 RA vs DPP-4i GLP-1 RA - exposure group DPP-4i - referent group | GLP-1RA Any SGLT2i dispensing claim |
DPP-4i (Comparison 3) For GLP-1 RA vs DPP-4i GLP-1 RA - exposure group DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SGLT-2i (Comparison 4) For SGLT-2i vs SU SGLT-2i - exposure group SU - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
SU (Comparison 4) For SGLT-2i vs SU SGLT-2i - exposure group SU - referent group | 2nd generation SU Any 2nd generation SU claim |
GLP-1 RA (Comparison 5) For GLP-1 RA vs SU GLP-1 RA - exposure group SU - referent group | GLP-1RA Any SGLT2i dispensing claim |
SU (Comparison 5) For GLP-1 RA vs SU GLP-1 RA - exposure group SU - referent group | 2nd generation SU Any 2nd generation SU claim |
DPP-4i (Comparison 6) For DPP-4i vs SU DPP-4i - exposure group SU - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SU (Comparison 6) For DPP-4i vs SU DPP-4i - exposure group SU - referent group | 2nd generation SU Any 2nd generation SU claim |
SGLT2i (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | GLP-1RA Any SGLT2i dispensing claim |
DPP-4i (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SU (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | 2nd generation SU Any 2nd generation SU claim |
SGLT2i (Comparison 8) For SGLT2i vs. GLP-1RA vs. DPP-4i (3-way comparison) SGLT2i and GLP-1 RA - exposure groups DPP-4i - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 8) For SGLT2i vs. GLP-1RA vs. DPP-4i (3-way comparison) SGLT2i and GLP-1 RA - exposure groups DPP-4i - referent group | GLP-1RA Any SGLT2i dispensing claim |
DPP-4i (Comparison 8) For SGLT2i vs. GLP-1RA vs. DPP-4i (3-way comparison) SGLT2i and GLP-1 RA - exposure groups DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
MACE | Myocardial Infarction, Ischemic Stroke, Cardiovascular mortality | through study completion, an average of 1 year |
Modified MACE | Myocardial Infarction, Ischemic Stroke, All-Cause mortality | through study completion, an average of 1 year |
Hospitalization for Heart Failure (HHF) Hospitalization for Heart Failure (HHF) | through study completion, an average of 1 year |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Myocardial Infarction (MI) | through study completion, an average of 1 year | |
Stroke | through study completion, an average of 1 year | |
Cardiovascular Mortality | through study completion, an average of 1 year | |
All-cause mortality | through study completion, an average of 1 year | |
Coronary revascularization | through study completion, an average of 1 year |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Age ≥ 18 years for Optum Cliniformatics, IBM Marketscan, CPRD, and VHA, and ≥ 65 years for Medicare FFS at cohort entry
- At least 12 months of continuous health plan enrollment (only claims) or registration with a general practitioner (CPRD) before and including cohort entry
- Diagnosis of T2D within 12 months before (or ever before in CPRD) and including cohort entry
- Low or moderate cardiovascular (CV) risk (≤3% risk of CV events/year) at cohort entry *
- Metformin maintenance therapy, defined as 2 fills (or prescriptions in CPRD) of metformin monotherapy recorded within 6 months before and including cohort entry
- Missing age or gender information
- Nursing care admission within 12 months before and including cohort entry (criteria ignored in CPRD)
- Diagnosis of type 1 diabetes within 12 months before and including cohort entry
- Diagnosis of secondary or gestational diabetes within 12 months before and including cohort entry
- Any insulin fill or prescription within 12 months before and including cohort entry
- Diagnosis of end stage renal disease (stage ≥ 5) within 12 months before and including cohort entry
- Diagnosis of acute or chronic pancreatitis within 12 months before and including cohort entry
- Diagnosis of cirrhosis or acute hepatitis within 12 months before and including cohort entry
- Diagnosis of MEN-2 within 12 months before and including cohort entry
- Recorded solid organ transplant code within 12 months before and including cohort entry
- Patients with recorded initiation of more than one agent within a comparator class at cohort entry
Brigham and Women's Krankenhaus398 aktive klinische Studien zum ErkundenVerantwortliche Partei
Elisabetta Patorno, Hauptprüfer, Associate Professor of Medicine, Brigham and Women's Hospital
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1 Studienstandorte in 1 Ländern
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02120, United States