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NCT03249506 · ClinicalTrials.gov registry record
Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)
A clinical trial, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 25,358
- Enrollment target
NCT03249506: Completed study, sponsored by Janssen Research & Development.
NCT03249506 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 25,358 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03249506 has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 25,358 participants
- Enrollment target
Study Summary
The purpose of this study is to identify and evaluate the event rate of the composite endpoint of all-cause mortality (ACM) or hospitalization for heart failure (HF) for participants with Type 2 Diabetes mellitus (T2DM) and established cardiovascular (CV) disease among new users of sodium-glucose co-transporter 2 inhibitor (SGLT2i) as compared with new users of non-SGLT2i anti-hyperglycemic agent (AHA).
Primary Outcome
Composite of ACM and hospitalization of HF will be assessed in participants with type 2 diabetes mellitus. ACM is defined as any record of death regardless of the cause of death and is identified through a master death file within the military health system (MHS) that compiles, processes, and validates all death records from the following data sources: inpatient hospitalization discharge dispositions from military and civilian hospitals, ambulatory and outpatient encounter records with recorded
Interventions
- DRUG Empagliflozin
- DRUG Dapagliflozin
- DRUG Canagliflozin
- DRUG Dipeptidyl Peptidase-4 Inhibitor (DPP-4)
- DRUG Glucagon-Like Peptide-1 Agonist (GLP-1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25,358 participants |
| Start Date | 2016-05-12 |
| Est. Completion | 2017-11-01 |
What the finished NCT03249506 record still lists
NCT03249506 is an observational study that tracks outcomes without assigning an intervention. Its 25,358 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 5 interventions - of which Empagliflozin is the first listed.
NCT03249506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03249506 about?
NCT03249506 is a clinical study titled "Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)". The purpose of this study is to identify and evaluate the event rate of the composite endpoint of all-cause mortality (ACM) or hospitalization for heart failure (HF) for participants with Type 2 Diabetes mellitus (T2DM) and established cardiovascular (CV) disease among new users of sodium-glucose co...
What is the current status of trial NCT03249506?
This trial is currently completed. The enrollment target is 25,358 participants. The study started on 2016-05-12. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT03249506?
The interventions under investigation include: Empagliflozin (DRUG), Dapagliflozin (DRUG), Canagliflozin (DRUG), Dipeptidyl Peptidase-4 Inhibitor (DPP-4) (DRUG), Glucagon-Like Peptide-1 Agonist (GLP-1) (DRUG).
Who is sponsoring clinical trial NCT03249506?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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