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Clinical Trial Details

Trial ID: L5949
Source ID: NCT03249506
Associated Drug: Canagliflozin
Title: Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Canagliflozin|DRUG: Empagliflozin|DRUG: Dapagliflozin|DRUG: Dipeptidyl Peptidase-4 Inhibitor (DPP-4)|DRUG: Glucagon-Like Peptide-1 Agonist (GLP-1)|DRUG: Thiazolidinedione (TZD)|DRUG: Sulfonylureas|DRUG: Insulin
Outcome Measures: Primary: Incidence Rate of the Composite of All-cause Mortality (ACM) or Hospitalization for Heart Failure (HF), 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 death disposition, casualty death feed related to active duty service member combat related deaths, survivor self-report, and an established, recurring social security death index (SSDI) feed from the social security administration. Hospitalization for HF will be defined as any inpatient hospitalization record, inclusive of both military and civilian hospitals, with an international classification of disease-9th or 10th edition (ICD-9/10) in the primary diagnosis field., approximately 3 years | Secondary: Incidence Rate of All-Cause Mortality, ACM is defined as any record of death regardless of the cause of death and is identified through a master death file within 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 death disposition, casualty death feed related to active duty service member combat related deaths, survivor self-report, and an established, recurring SSDI feed from the social security administration., approximately 3 years|Incidence Rate of Hospitalization for HF, Hospitalization for HF will be defined as any inpatient hospitalization record, inclusive of both military and civilian hospitals, with an international classification of disease-9th or 10th edition (ICD-9/10) in the primary diagnosis field., approximately 3 years|Incidence Rate of Major Adverse Cardiovascular Events (MACE), MACE will be defined as the composite endpoint of ACM, non-fatal stroke, or non-fatal myocardial infarction (MI)., approximately 3 years|Incidence Rate of Composite of MACE or Hospitalization for HF, Participants for composite of ACM and hospitalization of HF will be assessed. MACE will be defined as the composite endpoint of ACM, non-fatal stroke, or non-fatal myocardial infarction (MI). Hospitalization for HF will be defined as any inpatient hospitalization record, inclusive of both military and civilian hospitals, with an international classification of disease-9th or 10th edition (ICD-9/10) in the primary diagnosis field., approximately 3 years|Incidence Rate of Non-fatal stroke, Non-fatal stroke will be defined as any inpatient hospitalization record, inclusive of both military and civilian hospitals, with an ICD-9/10 in the primary diagnosis field pertaining to either ischemic stroke or hemorrhagic stroke and the participant did not die during the index hospitalization., approximately 3 years|Incidence Rate of Non-Fatal Myocardial Infarction, Non-fatal MI will be defined as any inpatient hospitalization record, inclusive of both military and civilian hospitals, with an ICD-9/10 in the primary diagnosis field and the participant did not die during the index hospitalization., approximately 3 years|Percentage of Participants With Below Knee Lower Extremity (BKLE) Amputation, The occurrence of a below-knee lower extremity amputation will be defined by observing an associated procedure code in the outpatient or inpatient medical service claims., approximately 3 years
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 25358
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2016-05-12
Completion Date: 2017-11-01
Results First Posted:
Last Update Posted: 2017-11-21
Locations: Health ResearchTx, LLC, Trevose, Pennsylvania, 19053, United States
URL: https://clinicaltrials.gov/show/NCT03249506