Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249506
• Other study ID #: CR108355
• Secondary ID: RRA-17640
• Status: Completed
• Phase: N/A
• First received: August 11, 2017
• Last updated: November 17, 2017
• Start date: May 12, 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: November 2017
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25358
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Health ResearchTx, LLC	Trevose	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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