Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT03249506
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
25358 participants
OBSERVATIONAL
2016-05-12
2017-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1: Non-SGLT2i new Users
This is a retrospective cohort study identifying participants with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease using the Military Health System (MHS) over a 3-year period. Cohort 1 included participants with incident exposure of one or more non-sodium glucose co-transporter 2 inhibitor (SGLT2i) anti-hyperglycemic agent (AHA) therapy during the study period with no prior or subsequent SGLT2i exposure throughout the study period. New users are defined as participants whose first exposure to any non-metformin AHA medication occurs greater than or equal to (\>=) 365 days after their start of observation in the database with no prior exposure to any medication within the same AHA medication class in the prior 365 days.
Dipeptidyl Peptidase-4 Inhibitor (DPP-4)
Participants who received a DPP-4 as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Glucagon-Like Peptide-1 Agonist (GLP-1)
Participants who received a GLP-1 as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Thiazolidinedione (TZD)
Participants who received a TZD as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Sulfonylureas
Participants who received a sulfonylureas as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Insulin
Participants who received a insulin as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Cohort 2: SGLT2i new Users
Cohort 2 included participants with incident SGLT2i exposure during the study period regardless of prior or concurrent exposure to one or more additional AHA therapy. New users are defined as participants whose first exposure to SGLT2i medication occurs \>= 365 days after their start of observation in the database with no prior exposure to the same AHA medication class in the prior 365 days.
Canagliflozin
Participants who received canagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
Empagliflozin
Participants who received empagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
Dapagliflozin
Participants who received dapagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
Interventions
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Canagliflozin
Participants who received canagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
Empagliflozin
Participants who received empagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
Dapagliflozin
Participants who received dapagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
Dipeptidyl Peptidase-4 Inhibitor (DPP-4)
Participants who received a DPP-4 as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Glucagon-Like Peptide-1 Agonist (GLP-1)
Participants who received a GLP-1 as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Thiazolidinedione (TZD)
Participants who received a TZD as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Sulfonylureas
Participants who received a sulfonylureas as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Insulin
Participants who received a insulin as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
Eligibility Criteria
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Inclusion Criteria
* Established cardiovascular disease, defined as \>=1 diagnosis in any diagnosis field for any of the following conditions: cerebrovascular disease; coronary artery disease (including heart failure \[HF\]); peripheral artery disease
* \>=1-year pre-index continuous eligibility; enrollment gaps of less than or equal to (\<=) 30 days will be considered continuous enrollment
Exclusion Criteria
* Secondary diabetes mellitus (DM) on or prior to the index date
* Missing sex data
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Health ResearchTx, LLC
Trevose, Pennsylvania, United States
Countries
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Other Identifiers
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RRA-17640
Identifier Type: OTHER
Identifier Source: secondary_id
CR108355
Identifier Type: -
Identifier Source: org_study_id