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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

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ClinicalTrials.gov Identifier: NCT03492580
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Cardiovascular Diseases Drug: Canagliflozin Drug: Empagliflozin Drug: Dapagliflozin Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Drug: Glucagon-like Peptide-1 (GLP-1) Agonist Drug: Anti-hyperglycemic Agents (AHA) Drug: Thiazolidinediones (TZD) Drug: Sulfonylureas (SU) Drug: Insulin

Study Type : Observational
Estimated Enrollment : 714582 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Patients With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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).
Drug: Canagliflozin
No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice.

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.
Drug: Canagliflozin
No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice.

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.
Drug: Empagliflozin
No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.

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.
Drug: Empagliflozin
No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.

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.
Drug: Dapagliflozin
No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.

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.
Drug: Dapagliflozin
No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.

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.
Drug: Empagliflozin
No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.

Drug: Dapagliflozin
No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.

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.
Drug: Empagliflozin
No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.

Drug: Dapagliflozin
No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.

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.
Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
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.

Drug: Glucagon-like Peptide-1 (GLP-1) Agonist
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.

Drug: Anti-hyperglycemic Agents (AHA)
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.

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.
Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
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.

Drug: Glucagon-like Peptide-1 (GLP-1) Agonist
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.

Drug: Anti-hyperglycemic Agents (AHA)
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.

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.
Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
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.

Drug: Glucagon-like Peptide-1 (GLP-1) Agonist
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.

Drug: Anti-hyperglycemic Agents (AHA)
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.

Drug: Thiazolidinediones (TZD)
No intervention or treatment assignment imposed by this study. Participants received TZD as a part of routine clinical practice. TZDs includes: pioglitazone, rosiglitazone, troglitazone.

Drug: Sulfonylureas (SU)
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

Drug: Insulin
No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice.

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.
Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
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.

Drug: Glucagon-like Peptide-1 (GLP-1) Agonist
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.

Drug: Anti-hyperglycemic Agents (AHA)
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.

Drug: Thiazolidinediones (TZD)
No intervention or treatment assignment imposed by this study. Participants received TZD as a part of routine clinical practice. TZDs includes: pioglitazone, rosiglitazone, troglitazone.

Drug: Sulfonylureas (SU)
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

Drug: Insulin
No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice.




Primary Outcome Measures :
  1. Number of Hospitalizations for Heart Failure [ Time Frame: Approximately 4-years ]
    Number of hospital admissions with a primary diagnosis of 'heart failure' will be reported.

  2. Number of Participants with Below Knee Lower Extremity Amputation Events [ Time Frame: Approximately 4-years ]
    Number of participants with new below-knee lower extremity amputation procedures, excluding recent (within 30 day) revisions will be reported.



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Ages Eligible for Study:   Child, 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 over a 4-year period 1 April 2013 and 15 May 2017 will be observed.
Criteria

Inclusion Criteria:

  • First exposure to the particular drug(s) in database (index date)
  • Exposure start is between 1 April 2013 and 15 May 2017
  • At least 365 days of continuous observation time prior to index
  • At least 1 condition occurrence of 'Type II diabetes' any time in the prior continuous observation time (which is at least 365 days long) before or on the index date (first exposure to the particular drug(s) in database)

For cohort with 'established cardiovascular disease - At least 1 occurrence of 'conditions indicating established cardiovascular disease' on or any time in the prior continuous observation time (which is at least 365 days long) prior to the index date

Exclusion Criteria:

- Participants with type 1 diabetes or secondary diabetes prior to or on the index date of exposure were excluded from the study


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): NCT03492580


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
United States, New Jersey
Janssen Investigative Site Recruiting
Titusville, New Jersey, United States, 08560
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03492580     History of Changes
Other Study ID Numbers: CR108464
RRA-20250 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Insulin, Globin Zinc
Empagliflozin
2,4-thiazolidinedione
Insulin
Canagliflozin
Hypoglycemic Agents
Glucagon
Glucagon-Like Peptide 1
Dipeptidyl-Peptidase IV Inhibitors
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action