Diabetes Mellitus, Type 2, Cardiovascular Diseases
Conditions
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.
Interventions
DRUGCanagliflozin
No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice.
DRUGEmpagliflozin
No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.
DRUGDapagliflozin
No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.
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.
DRUGGlucagon-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.
DRUGAnti-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.
DRUGThiazolidinediones (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.
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
DRUGInsulin
No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice.
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospitalizations for Heart Failure | 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 | Approximately 4-years | Number of participants with new below-knee lower extremity amputation procedures, excluding recent (within 30 day) revisions will be reported. |
Countries
United States
Outcome results
None listed