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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Drug: Canagliflozin; Drug: Empagliflozin; Drug: Glucagon-like Peptide-1 (GLP-1) Agonist; Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors; Drug: Sulfonylureas (SU); Drug: Anti-hyperglycemic Agents (AHA); Drug: Thiazolidinediones (TZD); Drug: Dapagliflozin; Drug: Insulin

Study type: Observational

Funder types: Industry

Identifiers

NCT03492580

RRA-20250 (Other Identifier)

CR108464

Details and patient eligibility

About

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.

Enrollment: 714,582 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

714,582 participants in 12 patient groups

Cohort 1: Canagliflozin

Description:

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).

Treatment:

Drug: Canagliflozin

Cohort 2: Canagliflozin with Cardiovascular Disease (CVD)

Description:

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.

Treatment:

Drug: Canagliflozin

Cohort 3: Empagliflozin

Description:

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.

Treatment:

Drug: Empagliflozin

Cohort 4: Empagliflozin with CVD

Description:

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.

Treatment:

Drug: Empagliflozin

Cohort 5: Dapagliflozin

Description:

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.

Treatment:

Drug: Dapagliflozin

Cohort 6: Dapagliflozin with CVD

Description:

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.

Treatment:

Drug: Dapagliflozin

Cohort 7: Empagliflozin or Dapagliflozin

Description:

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.

Treatment:

Drug: Dapagliflozin

Drug: Empagliflozin

Cohort 8: Empagliflozin or Dapagliflozin with CVD

Description:

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.

Treatment:

Drug: Dapagliflozin

Drug: Empagliflozin

Cohort 9: DPP-4 inhibitor (i)/ GLP-1 agonist (a)/ other AHA

Description:

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.

Treatment:

Drug: Anti-hyperglycemic Agents (AHA)

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

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

Cohort 10: DPP-4 (i)/ GLP-1 (a)/ other AHA with CVD

Description:

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.

Treatment:

Drug: Anti-hyperglycemic Agents (AHA)

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

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

Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA

Description:

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.

Treatment:

Drug: Insulin

Drug: Thiazolidinediones (TZD)

Drug: Sulfonylureas (SU)

Drug: Anti-hyperglycemic Agents (AHA)

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

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

Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD

Description:

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.

Treatment:

Drug: Insulin

Drug: Thiazolidinediones (TZD)

Drug: Sulfonylureas (SU)

Drug: Anti-hyperglycemic Agents (AHA)

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

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