A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

Part of paid clinical trials in Titusville, New Jersey.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03492580
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice.
  • Empagliflozin — DRUG
    No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.
  • Dapagliflozin — DRUG
    No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.
  • Dipeptidyl Peptidase-4 (DPP-4) Inhibitors — DRUG
    No intervention or treatment assignment imposed by this study. Participants received DPP-4 inhibitor as a part of routine clinical practice. DPP-4 inhibitors includes: alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin.
  • Glucagon-like Peptide-1 (GLP-1) Agonist — DRUG
    No intervention or treatment assignment imposed by this study. Participants received GLP-1 agonist as a part of routine clinical practice. GLP-1 agonists includes: albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide.
  • Anti-hyperglycemic Agents (AHA) — DRUG
    No intervention or treatment assignment imposed by this study. Participants received other selected AHA as a part of routine clinical practice. Other select AHAs includes: acarbose, bromocriptine, miglitol, nateglinide, repaglinide.
  • Thiazolidinediones (TZD) — DRUG
    No intervention or treatment assignment imposed by this study. Participants received TZD as a part of routine clinical practice. TZDs includes: pioglitazone, rosiglitazone, troglitazone.
  • Sulfonylureas (SU) — DRUG
    No intervention or treatment assignment imposed by this study. Participants received SU as a part of routine clinical practice. SUs includes: glipizide, glyburide, glimepiride, chlorpropamide, tolazamide, tolbutamide, acetohexamide
  • Insulin — DRUG
    No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice.

Study Details

The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. The date of first exposure to the particular drug(s) in the database, where the exposure start is between 1-April-2013 to 15-May-2017 and outcome data for these participants will be analyzed and reported in this study.

Key Dates

Start date
Feb 22, 2018
Status verified
Jun 2025
Primary completion
Apr 6, 2018
Completion
Jun 25, 2018

Study Design

Enrollment
714,582 participants (actual)

Arms

  • Arm: Cohort 1: Canagliflozin
    A target cohort which includes new users of canagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. Truven Health MarketScan Commercial Claims and Encounters Database (CCAE) 2. Truven Health MarketScan Medicare Supplemental and Coordination of Benefits Database (MDCR) 3. Truven Health MarketScan Multi-state Medicaid Database (MDCD) 4. OptumInsight's de-identified Clinformatics Datamart, Extended-Date of Death (Optum).
  • Arm: Cohort 2: Canagliflozin with Cardiovascular Disease (CVD)
    A target cohort which includes new users of canagliflozin with established CVD for clinical characterization and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 3: Empagliflozin
    A comparator cohort which includes new users of empagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 4: Empagliflozin with CVD
    A comparator cohort which includes new users of empagliflozin with established CVD for clinical characterization and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 5: Dapagliflozin
    A comparator cohort which includes new users of dapagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 6: Dapagliflozin with CVD
    A comparator cohort which includes new users of dapagliflozin with established CVD for clinical characterization and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 7: Empagliflozin or Dapagliflozin
    A target cohort which includes new users of empagliflozin or dapagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 8: Empagliflozin or Dapagliflozin with CVD
    A target cohort which includes new users of empagliflozin or dapagliflozin with established CVD for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 9: DPP-4 inhibitor (i)/ GLP-1 agonist (a)/ other AHA
    A comparator cohort which includes new users of any dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) agonist, or other select antihyperglycemic agents (AHA) for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 10: DPP-4 (i)/ GLP-1 (a)/ other AHA with CVD
    A comparator cohort which includes new users of any DPP-4 inhibitor, GLP-1 agonist, or other select AHA with established CVD for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA
    A comparator cohort which includes new users of any DPP-4 inhibitor, GLP-1 agonist, thiazolidinediones (TZD), sulfonylureas (SU), insulin, or other select AHA for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.
  • Arm: Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD
    A comparator cohort which includes new users of any DPP-4 inhibitor, GLP-1 agonist, TZD, SU, insulin, or other select AHA with established CVD for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum.

Primary Outcome Measure

Number of Hospitalizations for Heart Failure [ Time Frame: Approximately 4-years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Janssen Investigative SiteTitusvilleNew Jersey08560-

Find similar trials in Titusville, NJ

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Janssen Investigative Site· Titusville, NJ

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