Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

25,358

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started May 2016

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

May 12, 2016

Completed

1.2 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed

Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

August 11, 2017

Last Update Submit

November 17, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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 Outcomes (7)

Incidence Rate of All-Cause Mortality
approximately 3 years
Incidence Rate of Hospitalization for HF
approximately 3 years
Incidence Rate of Major Adverse Cardiovascular Events (MACE)
approximately 3 years
Incidence Rate of Composite of MACE or Hospitalization for HF
approximately 3 years
Incidence Rate of Non-fatal stroke
approximately 3 years
+2 more secondary outcomes

Study Arms (2)

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.

Drug: Dipeptidyl Peptidase-4 Inhibitor (DPP-4)Drug: Glucagon-Like Peptide-1 Agonist (GLP-1)Drug: Thiazolidinedione (TZD)Drug: SulfonylureasDrug: Insulin

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.

Drug: CanagliflozinDrug: EmpagliflozinDrug: Dapagliflozin

Interventions

CanagliflozinDRUG

Participants who received canagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.

Cohort 2: SGLT2i new Users

EmpagliflozinDRUG

Participants who received empagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.

Cohort 2: SGLT2i new Users

DapagliflozinDRUG

Participants who received dapagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.

Cohort 2: SGLT2i new Users

Dipeptidyl Peptidase-4 Inhibitor (DPP-4)DRUG

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.