Severe Complications of Urinary Tract InfectionsNCT02695173
Complications of UTI in Patients on Dapagliflozin
An observational study of Severe Complications of Urinary Tract Infections, run by AstraZeneca at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Complications of Urinary Tract Infections
- How many people
- 683,380 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jan 2017to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with type 2 diabetes mellitus who are new users of dapagliflozin with those who are new users of antidiabetic drugs in classes other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy. Up to four comparator subjects will be matched to each dapagliozin user.
Who may be able to join
- 18 years and older (CPRD and HIRD), or 65 years or older (Medicare);
- no diagnosisi of type 1 diabetes,
- are new users of one of the study drugs and
- have at least 180 days of electronic data before their first prescription of the study drug
Who cannot join
- The patient experienced chronic pyelonephritis at any time before the index date (i.e., during the available lookback time).
- The patient was prescribed an SGLT2 inhibitor other than dapagliflozin on or before the index date.
- The patient initiated metformin or sulfonylurea as AD monotherapy at the index date.
- The patient initiated insulin therapy at the index date.
- The patient had evidence of type 1 diabetes before cohort entry or first recorded AD is insulin monotherapy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Research Site
Washington D.C., District of Columbia
Research Site
Wilmington, Delaware
About this study
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
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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urinary tract infections (UTI) complications
Patients will be followed from their index date (date of first study drug prescription or dispensing) until they experience one of the following: an event under study, end of time at risk for index medication, death, addition of a non-dapagliflozin SGLT2 inhibitor, termination of health plan or transfer out of the GP practice, or end of the study period (up to six years)
Measured: Day after index date up to six years
Secondary outcomes (1)
Incidence of pyelonephritis
Patients will be followed from their index date (date of first study drug prescription or dispensing) until they experience one of the following: an event under study, end of time at risk for index medication, death, addition of a non-dapagliflozin SGLT2 inhibitor, termination of health plan or transfer out of the GP practice, or end of the study period (up to six years)
Measured: Day after index date up to six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study start1 Jan 2017
- Primary completion1 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Complications of Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 683,380 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Johannes, Dr, Principal investigator, RTI Health Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695173
- Sponsor's protocol ID
- D1690R00008
- Other IDs
- EUPAS12113
- Status last verified
- Nov 2021
- First submitted
- 18 Feb 2016
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02695173
- Acronym / sponsor ID
- D1690R00008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 683,380 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus who are new users of dapagliflozin with those who are new users of antidiabetic drugs in classes other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy. Up to four comparator subjects will be matched to each dapagliozin user.
Key inclusion criteria (4 listed)
- 18 years and older (CPRD and HIRD), or 65 years or older (Medicare);
- no diagnosisi of type 1 diabetes,
- are new users of one of the study drugs and
- have at least 180 days of electronic data before their first prescription of the study drug
Key exclusion criteria (5 listed)
- The patient experienced chronic pyelonephritis at any time before the index date (i.e., during the available lookback time).
- The patient was prescribed an SGLT2 inhibitor other than dapagliflozin on or before the index date.
- The patient initiated metformin or sulfonylurea as AD monotherapy at the index date.
- The patient initiated insulin therapy at the index date.
- The patient had evidence of type 1 diabetes before cohort entry or first recorded AD is insulin monotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of urinary tract infections (UTI) complications
Time frame: Day after index date up to six years
Patients will be followed from their index date (date of first study drug prescription or dispensing) until they experience one of the following: an event under study, end of time at risk for index medication, death, addition of a non-dapagliflozin SGLT2 inhibitor, termination of health plan or transfer out of the GP practice, or end of the study period (up to six years)
1 secondary outcome
Incidence of pyelonephritis
Time frame: Day after index date up to six years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Johannes, Dr principal investigator
RTI Health Solutions
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Complications of Urinary Tract Infections, run by AstraZeneca at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urinary tract infections (UTI) complications (time frame: Day after index date up to six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.