Ignite Creation Date:
2024-05-06 @ 8:12 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02695173
Status:
COMPLETED
Last Update Posted:
2021-12-07
First Post:
2016-02-18
Brief Title:
Complications of UTI in Patients on Dapagliflozin
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Comparison of the Risk of Severe Complications of Urinary Tract Infections Between Patients With Type 2 Diabetes Exposed to Dapafliglozin and Those Exposed to Other Antidiabetic Treatments
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to compare by insulin use at the index date the sex-specific incidence of hospitalization or emergency department ED visit for severe complications of urinary tract infections UTI defined as pyelonephritis and urosepsis among patients with type 2 diabetes mellitus T2DM who are new users of dapagliflozin with those who are new users of antidiabetic drugs ADs in classes other than sodium-glucose cotransporter 2 SGLT2 inhibitors insulin monotherapy metformin monotherapy or sulfonylurea monotherapy
Detailed Description:
The overall goal of this research study is to estimate the sex-specific incidence of hospitalization or emergency department visit for severe complications of urinary tract infections defined as pyelonephritis and urosepsis in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs Dapagliflozin and other antidiabetic drugs are used to treat type 2 diabetes mellitus Because of the mechanism of action for dapagliflozin and results from small safety monitoring studies there is interest in further evaluating the safety of dapagliflozin in large populations
The study will be implemented in three administrative health care data sources in two countries in the United Kingdom the Clinical Practice Research Datalink CPRD and in the United States the Centers for Medicare and Medicaid Services CMS Medicare databases and the HealthCore Integrated Research Database HIRDSM Individuals in the databases will be included in the study if they meet the following age criteria 18 years and older CPRD and HIRD or 65 years or older Medicare and if they did not have type 1 diabetes are new users of one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug The study period starts July 1 2013 in CPRD January 1 2014 in PHARMO and January 9 2014 in the United States data sources and will end at the latest available data at each database at the time of analysis
The study will be implemented in three administrative health care data sources in two countries in the United Kingdom the Clinical Practice Research Datalink CPRD and in the United States the Centers for Medicare and Medicaid Services CMS Medicare databases and the HealthCore Integrated Research Database HIRDSM Individuals in the databases will be included in the study if they meet the following age criteria 18 years and older CPRD and HIRD or 65 years or older Medicare and if they did not have type 1 diabetes are new users of one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug The study period starts July 1 2013 in CPRD January 1 2014 in PHARMO and January 9 2014 in the United States data sources and will end at the latest available data at each database at the time of analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUPAS12113 | REGISTRY | ENCePP | None |