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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 714,582
- 试验地点
- 1
- 主要终点
- Number of Hospitalizations for Heart Failure
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Participants with type 1 diabetes or secondary diabetes prior to or on the index date of exposure were excluded from the study
研究组 & 干预措施
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.
干预措施: Empagliflozin (Drug)
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.
干预措施: Canagliflozin (Drug)
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).
干预措施: Canagliflozin (Drug)
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.
干预措施: Empagliflozin (Drug)
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.
干预措施: Dapagliflozin (Drug)
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.
干预措施: Dapagliflozin (Drug)
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.
干预措施: Empagliflozin (Drug)
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.
干预措施: Dapagliflozin (Drug)
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.
干预措施: Empagliflozin (Drug)
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.
干预措施: Dapagliflozin (Drug)
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.
干预措施: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Drug)
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.
干预措施: Glucagon-like Peptide-1 (GLP-1) Agonist (Drug)
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.
干预措施: Anti-hyperglycemic Agents (AHA) (Drug)
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.
干预措施: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Drug)
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.
干预措施: Glucagon-like Peptide-1 (GLP-1) Agonist (Drug)
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.
干预措施: Anti-hyperglycemic Agents (AHA) (Drug)
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.
干预措施: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Drug)
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.
干预措施: Glucagon-like Peptide-1 (GLP-1) Agonist (Drug)
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.
干预措施: Anti-hyperglycemic Agents (AHA) (Drug)
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.
干预措施: Thiazolidinediones (TZD) (Drug)
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.
干预措施: Sulfonylureas (SU) (Drug)
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.
干预措施: Insulin (Drug)
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.
干预措施: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Drug)
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.
干预措施: Glucagon-like Peptide-1 (GLP-1) Agonist (Drug)
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.
干预措施: Anti-hyperglycemic Agents (AHA) (Drug)
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.
干预措施: Thiazolidinediones (TZD) (Drug)
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.
干预措施: Sulfonylureas (SU) (Drug)
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.
干预措施: Insulin (Drug)
结局指标
主要结局
Number of Hospitalizations for Heart Failure
时间窗: Approximately 4-years
Number of hospital admissions with a primary diagnosis of 'heart failure' will be reported.
Number of Participants with Below Knee Lower Extremity Amputation Events
时间窗: Approximately 4-years
Number of participants with new below-knee lower extremity amputation procedures, excluding recent (within 30 day) revisions will be reported.
次要结局
未报告次要终点