Type 2 Diabetes MellitusNCT02681497
Use of Canagliflozin in Conjunction With Insulin in a Real-world Setting
An observational study of Type 2 Diabetes Mellitus, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study is a retrospective chart review study aiming to assess the characteristics and health outcomes of patients with type 2 diabetes treated with canagliflozin when used in addition to insulin therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 269 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Jul 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study will use data from an EMR-based (Web DR) researchable database, which has been used to study patient's socioeconomic characteristics, treatment patterns and health outcomes of patients with diabetes. The Web DR de-identified researchable database contains integrated demographic, clinical and laboratory test result data of patients who received care from outpatient diabetes clinics in London, Ontario. The database includes more than 16,000 patients and their clinic visit information since 2000. Adult individuals (age>=18) with type 2 diabetes registered in Web DR who have been treated with canagliflozin in conjunction with insulin therapy will be selected for this study.
Who may be able to join
- Type 2DM >18 years of age, diabetes patients on insulin who initiated Canagliflozin due to a need of tighter glycemic control .
Who cannot join
- glomerular filtration rate (GFR)<45, pregnancy, type 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics and Health Outcomes of Patients With Type 2 Diabetes Treated With Canagliflozin Added to Insulin Therapy in a Real-world Setting
This study is a retrospective chart review study aiming to assess the characteristics and health outcomes of patients with type 2 diabetes treated with canagliflozin when used in addition to insulin therapy. Furthermore, the project aims to establish an EMR-based cohort of patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin to allow for future longitudinal studies that investigate outcomes over a longer follow-up period, and whether canagliflozin (when used in addition to insulin therapy) has an impact on diabetes-related healthcare costs.
Read the detailed description
This retrospective study will use data from an Electronic Medical Record (EMR)-based database (Web based Diabetes Records (Web DR) researchable database), which has been used to study patient's socioeconomic characteristics, treatment patterns and health outcomes of patients with diabetes. The Web DR de-identified researchable database contains integrated demographic, clinical and laboratory test result data of patients who received care from outpatient diabetes clinics in London, Ontario. The database includes more than 16,000 patients and their clinic visit information since 2000.
Adult individuals (age>=18) with type 2 diabetes receiving , registered in Web DR who have been treated with canagliflozin in conjunction with insulin therapy will be selected for this study. The baseline period will be 6 months to allow for more complete observation of comorbidities and medication use patterns.
The main objective of this project is to assess the characteristics and health outcomes of patients with type 2 diabetes treated with canagliflozin when used in addition to insulin therapy.
HbA1c, lipid, blood pressure, weight and other clinical indicators will be gathered from lab results during the baseline period closest to the date of canagliflozin prescription and follow up period (the last clinical value within the follow-up period and >=30 days after the start of the medication data will be selected.
The type of insulin used and dosages prescribed during the study follow-up period will be extracted from the database to examine the insulin dosage prescription pattern and understand the use of insulin with canagliflozin and its impact on clinical outcomes.
Furthermore, use of oral antihyperglycemic agents (metformin, sulfonylureas, thiazolidinedione, alpha-glucosidase inhibitors, meglitinides, Dipeptidyl peptidase-4 (DPP-4) inhibitors, bromocriptine) and injectable antihyperglycemic therapies (pramlintide, Glucagon-like peptide-1 (GLP-1) receptor agonists) will be measured during the 6 months baseline period and the follow-up period of 3 and 6 months.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- canagliflozin, diabetes, SGLT2, real-world data
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1c value
mean change in HbA1c value at 6 months from baseline
Measured: baseline and 6 months
Secondary outcomes (8)
change in weight (kg)
mean change in weight at 6 months from baseline will be assessed
Measured: baseline and 6 months
change in blood pressure (both systolic and diastolic blood pressure)
mean change in blood pressure at 6 months from baseline will be assessed
Measured: baseline and 6 months
change in glomerular filtration rate
mean change in glomerular filtration rate at 6 months from baseline will be assessed
Measured: baseline and 6 months
change in Insulin dose
change in Insulin dose (units) at 6 months from baseline will be assessed
Measured: baseline and 6 months
Evidence of diabetic ketoacidosis documented
Number of evidence of diabetic ketoacidosis within the first 6 months from baseline will be assessed
Measured: within the first 6 months from baseline
Evidence of genital infections documented
Evidence of genital infections within the first 6 months from baseline will be assessed
Measured: within the first 6 months from baseline
Evidence of hypoglycemia events documented
Number of hypoglycemia events documented within the first 6 months will be assessed
Measured: within the first 6 months from baseline
Evidence of urinary tract infection (UTI) documented
Evidence of urinary tract infection (UTI)s documented within the first 6 months will be assessed
Measured: within the first 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Inc.
- Responsible party
- Principal investigator, Stewart Harris, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Stewart Harris, MD,MPH,FCFP,FACPM, Principal investigator, The Universtiy of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681497
- Sponsor's protocol ID
- 2843175DIA4018_Harris
- Status last verified
- Sep 2016
- First submitted
- 6 Feb 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Health Outcomes of Patients With Type 2 Diabetes Treated With Canagliflozin Added to Insulin Therapy in a Real-world Setting
- ClinicalTrials.gov ID
- NCT02681497
- Acronym / sponsor ID
- 2843175DIA4018_Harris
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- canagliflozin, diabetes, SGLT2, real-world data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Janssen Inc.
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Feb 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.
This study is a retrospective chart review study aiming to assess the characteristics and health outcomes of patients with type 2 diabetes treated with canagliflozin when used in addition to insulin therapy. Furthermore, the project aims to establish an EMR-based cohort of patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin to allow for future longitudinal studies that investigate outcomes over a longer follow-up period, and whether canagliflozin (when used in addition to insulin therapy) has an impact on diabetes-related healthcare costs.
Detailed description
This retrospective study will use data from an Electronic Medical Record (EMR)-based database (Web based Diabetes Records (Web DR) researchable database), which has been used to study patient's socioeconomic characteristics, treatment patterns and health outcomes of patients with diabetes. The Web DR de-identified researchable database contains integrated demographic, clinical and laboratory test result data of patients who received care from outpatient diabetes clinics in London, Ontario. The database includes more than 16,000 patients and their clinic visit information since 2000.
Adult individuals (age>=18) with type 2 diabetes receiving , registered in Web DR who have been treated with canagliflozin in conjunction with insulin therapy will be selected for this study. The baseline period will be 6 months to allow for more complete observation of comorbidities and medication use patterns.
The main objective of this project is to assess the characteristics and health outcomes of patients with type 2 diabetes treated with canagliflozin when used in addition to insulin therapy.
HbA1c, lipid, blood pressure, weight and other clinical indicators will be gathered from lab results during the baseline period closest to the date of canagliflozin prescription and follow up period (the last clinical value within the follow-up period and >=30 days after the start of the medication data will be selected.
The type of insulin used and dosages prescribed during the study follow-up period will be extracted from the database to examine the insulin dosage prescription pattern and understand the use of insulin with canagliflozin and its impact on clinical outcomes.
Furthermore, use of oral antihyperglycemic agents (metformin, sulfonylureas, thiazolidinedione, alpha-glucosidase inhibitors, meglitinides, Dipeptidyl peptidase-4 (DPP-4) inhibitors, bromocriptine) and injectable antihyperglycemic therapies (pramlintide, Glucagon-like peptide-1 (GLP-1) receptor agonists) will be measured during the 6 months baseline period and the follow-up period of 3 and 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study will use data from an EMR-based (Web DR) researchable database, which has been used to study patient's socioeconomic characteristics, treatment patterns and health outcomes of patients with diabetes. The Web DR de-identified researchable database contains integrated demographic, clinical and laboratory test result data of patients who received care from outpatient diabetes clinics in London, Ontario. The database includes more than 16,000 patients and their clinic visit information since 2000. Adult individuals (age>=18) with type 2 diabetes registered in Web DR who have been treated with canagliflozin in conjunction with insulin therapy will be selected for this study.
Key inclusion criteria (1 listed)
- Type 2DM >18 years of age, diabetes patients on insulin who initiated Canagliflozin due to a need of tighter glycemic control .
Key exclusion criteria (1 listed)
- glomerular filtration rate (GFR)<45, pregnancy, type 1
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
change in HbA1c value
Time frame: baseline and 6 months
mean change in HbA1c value at 6 months from baseline
8 secondary outcomes
change in weight (kg)
Time frame: baseline and 6 months
change in blood pressure (both systolic and diastolic blood pressure)
Time frame: baseline and 6 months
change in glomerular filtration rate
Time frame: baseline and 6 months
change in Insulin dose
Time frame: baseline and 6 months
Evidence of diabetic ketoacidosis documented
Time frame: within the first 6 months from baseline
Evidence of genital infections documented
Time frame: within the first 6 months from baseline
Evidence of hypoglycemia events documented
Time frame: within the first 6 months from baseline
Evidence of urinary tract infection (UTI) documented
Time frame: within the first 6 months from baseline
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 13 Sep 2016.
- 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.
Stewart Harris, MD,MPH,FCFP,FACPM principal investigator
The Universtiy of Western Ontario
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 Type 2 Diabetes Mellitus, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 1 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 13 Sep 2016. 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?
change in HbA1c value (time frame: baseline and 6 months). 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 13 Sep 2016.