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| ID | Type | Description | Link |
|---|---|---|---|
| RRA-20250 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| 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. |
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| 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. |
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| Cohort 5: Dapagliflozin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin | Drug | No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospitalizations for Heart Failure | Number of hospital admissions with a primary diagnosis of 'heart failure' will be reported. | Approximately 4-years |
| Number of Participants with Below Knee Lower Extremity Amputation Events | Number of participants with new below-knee lower extremity amputation procedures, excluding recent (within 30 day) revisions will be reported. | Approximately 4-years |
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Inclusion Criteria:
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
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Janssen Investigative Site | Titusville | New Jersey | 08560 | United States |
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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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Empagliflozin | Drug | No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice. |
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| Dapagliflozin | Drug | No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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 |
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| Insulin | Drug | No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| C570240 | empagliflozin |
| C529054 | dapagliflozin |
| D052216 | Glucagon-Like Peptide 1 |
| D045162 | Thiazolidinediones |
| D013453 | Sulfonylurea Compounds |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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