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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249506
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 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

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Study Type : Observational
Actual Enrollment : 25358 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : May 12, 2016
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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.

Drug: 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.

Drug: 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.

Drug: 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.

Drug: 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.
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.

Drug: 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.

Drug: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease using the military health system (MHS) over a 3-year period (4/01/2013 to 3/31/2016) will be observed for the cardiovascular outcomes.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249506


Locations
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United States, Pennsylvania
Health ResearchTx, LLC
Trevose, Pennsylvania, United States, 19053
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03249506    
Other Study ID Numbers: CR108355
RRA-17640 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Empagliflozin
Canagliflozin
2,4-thiazolidinedione
Dipeptidyl-Peptidase IV Inhibitors
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Protease Inhibitors
Enzyme Inhibitors