Skip to main content
OpenTrials
Completed

NCT Number: NCT03249506

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-transporter 2 inhibitor (SGLT2i) as compared with new users of non-SGLT2i anti-hyperglycemic agent (AHA).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health ResearchTx, LLC

Trevose, Pennsylvania, 19053, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes mellitus (T2DM), defined as: greater than or equal to (>=) 1 anti-hyperglycemic agent (AHA) medication in the study period, and; >=1 diagnosis of T2DM in any available diagnosis field on or prior to index
  • 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

  • Type 1 Diabetes mellitus (T1DM) diagnosis on or prior to the index date
  • Secondary diabetes mellitus (DM) on or prior to the index date
  • Missing sex data

Treatment and study plan

Canagliflozin

Drug

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

Drug

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

Drug

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)

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.

Glucagon-Like Peptide-1 Agonist (GLP-1)

Drug

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)

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. Incidence Rate of the Composite of All-cause Mortality (ACM) or Hospitalization for Heart Failure (HF)

    Time frame: approximately 3 years

    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.

Secondary outcomes

  1. Incidence Rate of All-Cause Mortality

    Time frame: approximately 3 years

    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.

  2. Incidence Rate of Hospitalization for HF

    Time frame: approximately 3 years

    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.

  3. Incidence Rate of Major Adverse Cardiovascular Events (MACE)

    Time frame: approximately 3 years

    MACE will be defined as the composite endpoint of ACM, non-fatal stroke, or non-fatal myocardial infarction (MI).

  4. Incidence Rate of Composite of MACE or Hospitalization for HF

    Time frame: approximately 3 years

    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.

  5. Incidence Rate of Non-fatal stroke

    Time frame: approximately 3 years

    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.

  6. Incidence Rate of Non-Fatal Myocardial Infarction

    Time frame: approximately 3 years

    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.

  7. Percentage of Participants With Below Knee Lower Extremity (BKLE) Amputation

    Time frame: approximately 3 years

    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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2017
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.