Diabetes Mellitus, Type 2NCT04017221
Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2 and Urosepsis, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
Trial summary
The purpose of this study is to compare the risk of serious adverse events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Urosepsis, Diabetic Ketoacidosis
- What is being tested?
- Sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dipeptidyl peptidase-4 (DPP-4) inhibitors and Other treatment combinations
- How many people
- 1,249,636 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 1 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In each jurisdiction, the investigators will assemble a source population that includes all patients who received an antidiabetic medication between January 1, 2006 and June 30, 2018. From this source population, a study cohort including all new users of SGLT2 inhibitors or DPP-4 inhibitors between January 1, 2013 and June 30, 2018 will be created for each safety outcome. Specific exclusion criteria will be applied for each study cohort. Study cohort entry date will be defined by the dispensation date (or prescription for CPRD) of the newly prescribed SGLT2 or DPP-4 inhibitor.
Who may be able to join
- Patients who newly initiated a SGLT2 inhibitor or DPP-4 inhibitor between January 1, 2013 and June 30, 2018 (or latest date of data availability at each site)
Who cannot join
- Patients aged less than 18 years at cohort entry date (<66 years in Ontario)
- Patients with less than 365 days of health care coverage prior to cohort entry
- Patients with a hospitalization for urinary tract infection or acute pyelonephritis in the 30 days prior to cohort entry (for urosepsis study cohort only)
- Patients with spinal cord injuries affecting the bladder (for urosepsis study cohort only)
- Patients with long-term urinary catheter use (for urosepsis study cohort only)
- Patients with a hospitalization for DKA in the year prior to cohort entry (for DKA study cohort only)
- Patients with a history of lower extremity amputation at any time prior to cohort entry (for lower extremity amputation study cohort only)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Lady Davis Institute for Medical Research, Jewish General Hospital
Montreal, Quebec, H3T1E2
About this study
Official title: Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes: a Multicenter Cohort Study
The purpose of this study is to compare the risk of serious adverse events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. More specifically, the investigators will assess the risk of severe urinary tract infection (urosepsis), diabetic ketoacidosis and lower extremity amputation. The investigators hypothesize that the use of SGLT2 inhibitors will be associated with an increased risk of serious adverse events in comparison with the use of DPP-4 inhibitors.
The investigators will carry out separate population-based cohort studies using health care databases in seven Canadian provinces and the United Kingdom. Separate study cohorts will be created for each of the three safety outcomes. The study cohorts will be defined by the initiation of a SGLT2 inhibitor or a DPP-4 inhibitor after SGLT2 inhibitors entered the market. Patients will be followed up until the occurrence of an adverse event. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the risk of serious adverse events in users of SGLT2 inhibitors in comparison to users of DPP-4 inhibitors.
Read the detailed description
The objective of this study is to compare the risk of serious adverse events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. More specifically, the investigators will assess the risk of severe urinary tract infection (urosepsis), diabetic ketoacidosis (DKA) and lower extremity amputation.
A common-protocol approach will be used to conduct retrospective cohort studies using administrative health care data from seven Canadian provinces (Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, Quebec, and Saskatchewan) and the United Kingdom (UK) Clinical Practice Research Datalink (CPRD). Briefly, the Canadian databases include population-level data on physician billing, diagnoses and procedures from hospital discharge abstracts, and dispensations for prescription drugs. The data in Ontario will be restricted to patients aged 65 years old and older. The CPRD is a clinical database that is representative of the UK population and contains the records for patients seen at over 680 general practitioner practices in the UK; these data will be linked to the Hospital Episode Statistics (HES) database, which contains in-hospital diagnosis and procedure data.
In each jurisdiction, the investigators will assemble a source population that includes all patients who received an antidiabetic medication (metformin, sulfonylureas, thiazolidinediones, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, alpha-glucosidase inhibitors, meglitinides, insulin, or combinations of these drugs) between January 1, 2006 and June 30, 2018 (or the latest date of data availability at each site). From this source population, a study-specific cohort including all new users of SGLT2 inhibitors or DPP-4 inhibitors between January 1, 2013 and June 30, 2018 (or latest date of data availability at each site) will be created for each safety outcome. Specific exclusion criteria will be applied for each study cohort. Study cohort entry date will be defined by the dispensation date (or prescription for CPRD) of the newly prescribed SGLT2 or DPP-4 inhibitor. Patients will be followed until the occurrence of an event (defined below), death, end of health care coverage, or end of the study period, whichever occurs first.
Exposure will be defined using a time-varying exposure definition in which each person-day of follow-up will be classified into one of the following three mutually-exclusive categories: current use of SGLT2 inhibitors, current use of DPP-4 inhibitors, or other treatment combinations. For all categories, exposed person-time will be defined by the prescription duration plus a 30-day grace period. DPP-4 inhibitors will serve as the reference category as both classes are second- to third-line therapy. The outcome of interests include urosepsis, DKA and lower extremity amputation. In the urosepsis specific-study, Fournier's gangrene will be assessed in descriptive analyses as a secondary outcome.
Statistical analyses will be conducted separately for each study-specific cohort. Site-specific rates and corresponding corresponding 95% confidential intervals (CI) of each safety outcomes will be estimated using the Poisson distribution. Time-dependent Cox proportional hazards models with follow-up time as the underlying time axis will be used to estimate adjusted hazard ratios (HR) and corresponding 95% CI of the association between current use of SGLT2 and DPP-4 inhibitor use and urosepsis, DKA, and lower extremity amputation. As secondary analyses, each safety outcome will be stratified by age (≥70 and <70 years), sex and SGLT2 molecule. Sensitivity analyses will be performed to assess the robustness of study results and address some of the study limitations. Site-specific results will be combined by random-effects meta-analysis to provide an overall assessment of the risk of serious adverse events in users of SGLT2 inhibitors in comparison to users of DPP-4 inhibitors.
- Being tested
- Sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dipeptidyl peptidase-4 (DPP-4) inhibitors, Other treatment combinations
- Keywords
- Sodium-glucose cotransporter 2 inhibitors, Diabetes mellitus, type 2, Urosepsis, Diabetic ketoacidosis, Lower extremity amputation
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium-glucose cotransporter 2 (SGLT2) inhibitorsDrug
Also called ATC A10BK
Current exposure to SGLT2 will be defined as a prescription for a SGLT2 inhibitor (canagliflozin, dapagliflozin, empagliflozin) alone or in combination with other antidiabetic drugs, excluding DPP-4 inhibitors and insulin.
Dipeptidyl peptidase-4 (DPP-4) inhibitorsDrug
Also called ATC A10BH
Current exposure to DPP-4 will be defined as a prescription for a DPP-4 inhibitor (alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin) alone or in combination with other antidiabetic drugs, excluding SGLT2 inhibitors and insulin.
Other treatment combinationsDrug
Also called ATC A10A and A10B (excluding A10BH and A10BK)
Current exposure to other treatment combinations will be defined as a prescription of other antidiabetic drugs (metformin, sulfonylureas, thiazolidinediones, GLP-1 receptor agonists, alpha-glucosidase inhibitors, meglitinides, insulin, or combinations of these drugs), current use of insulin (alone or combination with other antidiabetic drugs), and non-current use of antidiabetic drugs.
| Study group | Role | What they receive |
|---|---|---|
| Sodium-glucose cotransporter 2 (SGLT2) inhibitors | Current use of a SGLT2 inhibitor alone or in combination with other antidiabetic drugs, excluding DPP-4 inhibitors and insulin. Receives: Drug: Sodium-glucose cotransporter 2 (SGLT2) inhibitors | |
| Dipeptidyl peptidase-4 (DPP-4) inhibitors | Current use of a DPP-4 inhibitor alone or in combination with other antidiabetic drugs, excluding SGLT2 inhibitors and insulin. Receives: Drug: Dipeptidyl peptidase-4 (DPP-4) inhibitors | |
| Other treatment combinations | Current use of other antidiabetic drugs, current use of insulin (alone or combination with other antidiabetic drugs), and non-current use of antidiabetic drugs. Receives: Drug: Other treatment combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of urosepsis
Urosepsis will be defined as a hospitalization with a diagnosis of acute pyelonephritis or urinary tract infection with a corresponding code for sepsis, using the following ICD-10-CA codes:
- Acute pyelonephritis (ICD-10-CA: N10) or urinary tract infection (ICD-10-CA: N30.0, N39.0) in combination with;
- Sepsis (ICD-10-CA: A41.x, R56.2, R57.2).
Measured: Patients will be followed from the date of study cohort entry until hospitalization for urosepsis, death, end of health care coverage, or for up to 64 months, whichever occurs first.
Incidence rate of diabetic ketoacidosis (DKA)
DKA will be defined as a hospitalization with a primary diagnosis of DKA or visit to the emergency department (in sites where this data is available) using the following ICD-10-CA codes: E11.10, E11.12, E13.10, E13.12.
Measured: Patients will be followed from the date of study cohort entry until hospitalization for DKA, death, end of health care coverage, or for up to 64 months, whichever occurs first.
Incidence rate of lower extremity amputation
Lower extremity amputation will be defined by procedure codes recorded in the hospital discharge abstract or the physician claims using the following CCI (Canadian Classification of Health Interventions) codes: 1VC93, 1VG93, 1VQ93, 1WA93, 1WE93, 1WI93, 1WJ93, 1WK93, 1WL93, 1WM93, 1WN93.
Measured: Patients will be followed from the date of study cohort entry until occurrence of a lower extremity amputation, death, end of health care coverage, or for up to 64 months, whichever occurs first.
Secondary outcomes (1)
Incidence rate of Fournier's gangrene
Fournier's gangrene will be defined as an inpatient diagnosis using the following ICD-10-CA codes: N49.3, N76.8, N76.88.
Measured: Patients will be followed from the date of study cohort entry until occurrence of Fournier's gangrene, death, end of health care coverage, or for up to 64 months, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Oct 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- 1,249,636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODES
- Sponsor type
- University, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Pierre Ernst, MD, MSc, FRCPC, Principal investigator, Lady Davis Institute for Medical Research, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017221
- Sponsor's protocol ID
- Q18-09/10/11
- Status last verified
- Aug 2020
- First submitted
- 3 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisher A, Fralick M, Filion KB, Dell'Aniello S, Douros A, Tremblay E, Shah BR, Ronksley PE, Alessi-Severini S, Hu N, Bugden SC, Ernst P, Lix LM; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Sodium-glucose co-transporter-2 inhibitors and the risk of urosepsis: A multi-site, prevalent new-user cohort study. Diabetes Obes Metab. 2020 Sep;22(9):1648-1658. doi: 10.1111/dom.14082. Epub 2020 Jun 4.
PubMed 32383792Yu OHY, Dell'Aniello S, Shah BR, Brunetti VC, Daigle JM, Fralick M, Douros A, Hu N, Alessi-Severini S, Fisher A, Bugden SC, Ronksley PE, Filion KB, Ernst P, Lix LM; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Sodium-Glucose Cotransporter 2 Inhibitors and the Risk of Below-Knee Amputation: A Multicenter Observational Study. Diabetes Care. 2020 Oct;43(10):2444-2452. doi: 10.2337/dc20-0267. Epub 2020 Aug 5.
PubMed 32759360Douros A, Lix LM, Fralick M, Dell'Aniello S, Shah BR, Ronksley PE, Tremblay E, Hu N, Alessi-Severini S, Fisher A, Bugden SC, Ernst P, Filion KB; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Sodium-Glucose Cotransporter-2 Inhibitors and the Risk for Diabetic Ketoacidosis : A Multicenter Cohort Study. Ann Intern Med. 2020 Sep 15;173(6):417-425. doi: 10.7326/M20-0289. Epub 2020 Jul 28.
PubMed 32716707
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04017221
- Acronym / sponsor ID
- Q18-09/10/11
- Keywords
- Sodium-glucose cotransporter 2 inhibitors, Diabetes mellitus, type 2, Urosepsis, Diabetic ketoacidosis, Lower extremity amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,249,636 participants (actual)
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODESUniversity, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 12 Jul 2019 (actual)
- 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 purpose of this study is to compare the risk of serious adverse events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. More specifically, the investigators will assess the risk of severe urinary tract infection (urosepsis), diabetic ketoacidosis and lower extremity amputation. The investigators hypothesize that the use of SGLT2 inhibitors will be associated with an increased risk of serious adverse events in comparison with the use of DPP-4 inhibitors.
The investigators will carry out separate population-based cohort studies using health care databases in seven Canadian provinces and the United Kingdom. Separate study cohorts will be created for each of the three safety outcomes. The study cohorts will be defined by the initiation of a SGLT2 inhibitor or a DPP-4 inhibitor after SGLT2 inhibitors entered the market. Patients will be followed up until the occurrence of an adverse event. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the risk of serious adverse events in users of SGLT2 inhibitors in comparison to users of DPP-4 inhibitors.
Detailed description
The objective of this study is to compare the risk of serious adverse events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. More specifically, the investigators will assess the risk of severe urinary tract infection (urosepsis), diabetic ketoacidosis (DKA) and lower extremity amputation.
A common-protocol approach will be used to conduct retrospective cohort studies using administrative health care data from seven Canadian provinces (Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, Quebec, and Saskatchewan) and the United Kingdom (UK) Clinical Practice Research Datalink (CPRD). Briefly, the Canadian databases include population-level data on physician billing, diagnoses and procedures from hospital discharge abstracts, and dispensations for prescription drugs. The data in Ontario will be restricted to patients aged 65 years old and older. The CPRD is a clinical database that is representative of the UK population and contains the records for patients seen at over 680 general practitioner practices in the UK; these data will be linked to the Hospital Episode Statistics (HES) database, which contains in-hospital diagnosis and procedure data.
In each jurisdiction, the investigators will assemble a source population that includes all patients who received an antidiabetic medication (metformin, sulfonylureas, thiazolidinediones, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, alpha-glucosidase inhibitors, meglitinides, insulin, or combinations of these drugs) between January 1, 2006 and June 30, 2018 (or the latest date of data availability at each site). From this source population, a study-specific cohort including all new users of SGLT2 inhibitors or DPP-4 inhibitors between January 1, 2013 and June 30, 2018 (or latest date of data availability at each site) will be created for each safety outcome. Specific exclusion criteria will be applied for each study cohort. Study cohort entry date will be defined by the dispensation date (or prescription for CPRD) of the newly prescribed SGLT2 or DPP-4 inhibitor. Patients will be followed until the occurrence of an event (defined below), death, end of health care coverage, or end of the study period, whichever occurs first.
Exposure will be defined using a time-varying exposure definition in which each person-day of follow-up will be classified into one of the following three mutually-exclusive categories: current use of SGLT2 inhibitors, current use of DPP-4 inhibitors, or other treatment combinations. For all categories, exposed person-time will be defined by the prescription duration plus a 30-day grace period. DPP-4 inhibitors will serve as the reference category as both classes are second- to third-line therapy. The outcome of interests include urosepsis, DKA and lower extremity amputation. In the urosepsis specific-study, Fournier's gangrene will be assessed in descriptive analyses as a secondary outcome.
Statistical analyses will be conducted separately for each study-specific cohort. Site-specific rates and corresponding corresponding 95% confidential intervals (CI) of each safety outcomes will be estimated using the Poisson distribution. Time-dependent Cox proportional hazards models with follow-up time as the underlying time axis will be used to estimate adjusted hazard ratios (HR) and corresponding 95% CI of the association between current use of SGLT2 and DPP-4 inhibitor use and urosepsis, DKA, and lower extremity amputation. As secondary analyses, each safety outcome will be stratified by age (≥70 and <70 years), sex and SGLT2 molecule. Sensitivity analyses will be performed to assess the robustness of study results and address some of the study limitations. Site-specific results will be combined by random-effects meta-analysis to provide an overall assessment of the risk of serious adverse events in users of SGLT2 inhibitors in comparison to users of DPP-4 inhibitors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sodium-glucose cotransporter 2 (SGLT2) inhibitors | – | Drug: Sodium-glucose cotransporter 2 (SGLT2) inhibitorsCurrent use of a SGLT2 inhibitor alone or in combination with other antidiabetic drugs, excluding DPP-4 inhibitors and insulin. |
| Dipeptidyl peptidase-4 (DPP-4) inhibitors | – | Drug: Dipeptidyl peptidase-4 (DPP-4) inhibitorsCurrent use of a DPP-4 inhibitor alone or in combination with other antidiabetic drugs, excluding SGLT2 inhibitors and insulin. |
| Other treatment combinations | – | Drug: Other treatment combinationsCurrent use of other antidiabetic drugs, current use of insulin (alone or combination with other antidiabetic drugs), and non-current use of antidiabetic drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In each jurisdiction, the investigators will assemble a source population that includes all patients who received an antidiabetic medication between January 1, 2006 and June 30, 2018. From this source population, a study cohort including all new users of SGLT2 inhibitors or DPP-4 inhibitors between January 1, 2013 and June 30, 2018 will be created for each safety outcome. Specific exclusion criteria will be applied for each study cohort. Study cohort entry date will be defined by the dispensation date (or prescription for CPRD) of the newly prescribed SGLT2 or DPP-4 inhibitor.
Key inclusion criteria (1 listed)
- Patients who newly initiated a SGLT2 inhibitor or DPP-4 inhibitor between January 1, 2013 and June 30, 2018 (or latest date of data availability at each site)
Key exclusion criteria (7 listed)
- Patients aged less than 18 years at cohort entry date (<66 years in Ontario)
- Patients with less than 365 days of health care coverage prior to cohort entry
- Patients with a hospitalization for urinary tract infection or acute pyelonephritis in the 30 days prior to cohort entry (for urosepsis study cohort only)
- Patients with spinal cord injuries affecting the bladder (for urosepsis study cohort only)
- Patients with long-term urinary catheter use (for urosepsis study cohort only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium-glucose cotransporter 2 (SGLT2) inhibitorsAlso: ATC A10BKCurrent exposure to SGLT2 will be defined as a prescription for a SGLT2 inhibitor (canagliflozin, dapagliflozin, empagliflozin) alone or in combination with other antidiabetic drugs, excluding DPP-4 inhibitors and insulin. | Drug | Sodium-glucose cotransporter 2 (SGLT2) inhibitors |
| Dipeptidyl peptidase-4 (DPP-4) inhibitorsAlso: ATC A10BHCurrent exposure to DPP-4 will be defined as a prescription for a DPP-4 inhibitor (alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin) alone or in combination with other antidiabetic drugs, excluding SGLT2 inhibitors and insulin. | Drug | Dipeptidyl peptidase-4 (DPP-4) inhibitors |
| Other treatment combinationsAlso: ATC A10A and A10B (excluding A10BH and A10BK)Current exposure to other treatment combinations will be defined as a prescription of other antidiabetic drugs (metformin, sulfonylureas, thiazolidinediones, GLP-1 receptor agonists, alpha-glucosidase inhibitors, meglitinides, insulin, or combinations of these drugs), current use of insulin (alone or combination with other antidiabetic drugs), and non-current use of antidiabetic drugs. | Drug | Other treatment combinations |
Primary outcome
Incidence rate of urosepsis
Time frame: Patients will be followed from the date of study cohort entry until hospitalization for urosepsis, death, end of health care coverage, or for up to 64 months, whichever occurs first.
Urosepsis will be defined as a hospitalization with a diagnosis of acute pyelonephritis or urinary tract infection with a corresponding code for sepsis, using the following ICD-10-CA codes: * Acute pyelonephritis (ICD-10-CA: N10) or urinary tract infection (ICD-10-CA: N30.0, N39.0) in combination with; * Sepsis (ICD-10-CA: A41.x, R56.2, R57.2).
Incidence rate of diabetic ketoacidosis (DKA)
Time frame: Patients will be followed from the date of study cohort entry until hospitalization for DKA, death, end of health care coverage, or for up to 64 months, whichever occurs first.
DKA will be defined as a hospitalization with a primary diagnosis of DKA or visit to the emergency department (in sites where this data is available) using the following ICD-10-CA codes: E11.10, E11.12, E13.10, E13.12.
Incidence rate of lower extremity amputation
Time frame: Patients will be followed from the date of study cohort entry until occurrence of a lower extremity amputation, death, end of health care coverage, or for up to 64 months, whichever occurs first.
Lower extremity amputation will be defined by procedure codes recorded in the hospital discharge abstract or the physician claims using the following CCI (Canadian Classification of Health Interventions) codes: 1VC93, 1VG93, 1VQ93, 1WA93, 1WE93, 1WI93, 1WJ93, 1WK93, 1WL93, 1WM93, 1WN93.
1 secondary outcome
Incidence rate of Fournier's gangrene
Time frame: Patients will be followed from the date of study cohort entry until occurrence of Fournier's gangrene, death, end of health care coverage, or for up to 64 months, whichever occurs first.
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 19 Sep 2024.
- Results publication: PubMed 32383792Fisher A, Fralick M, Filion KB, Dell'Aniello S, Douros A, Tremblay E, Shah BR, Ronksley PE, Alessi-Severini S, Hu N, Bugden SC, Ernst P, Lix LM; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Sodium-glucose co-transporter-2 inhibitors and the risk of urosepsis: A multi-site, prevalent new-user cohort study. Diabetes Obes Metab. 2020 Sep;22(9):1648-1658. doi: 10.1111/dom.14082. Epub 2020 Jun 4.
- Results publication: PubMed 32759360Yu OHY, Dell'Aniello S, Shah BR, Brunetti VC, Daigle JM, Fralick M, Douros A, Hu N, Alessi-Severini S, Fisher A, Bugden SC, Ronksley PE, Filion KB, Ernst P, Lix LM; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Sodium-Glucose Cotransporter 2 Inhibitors and the Risk of Below-Knee Amputation: A Multicenter Observational Study. Diabetes Care. 2020 Oct;43(10):2444-2452. doi: 10.2337/dc20-0267. Epub 2020 Aug 5.
- Results publication: PubMed 32716707Douros A, Lix LM, Fralick M, Dell'Aniello S, Shah BR, Ronksley PE, Tremblay E, Hu N, Alessi-Severini S, Fisher A, Bugden SC, Ernst P, Filion KB; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Sodium-Glucose Cotransporter-2 Inhibitors and the Risk for Diabetic Ketoacidosis : A Multicenter Cohort Study. Ann Intern Med. 2020 Sep 15;173(6):417-425. doi: 10.7326/M20-0289. Epub 2020 Jul 28.
- This is the website describing the general functions of the organization, other CNODES projects, and investigator profiles.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pierre Ernst, MD, MSc, FRCPC principal investigator
Lady Davis Institute for Medical Research, Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Urosepsis, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
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 1 inclusion and 7 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 rate of urosepsis (time frame: Patients will be followed from the date of study cohort entry until hospitalization for urosepsis, death, end of health care coverage, or for up to 64 months, whichever occurs first.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04017221, which also lists 3 linked publications.
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 19 Sep 2024.