Health Outcomes of Patients With Type 2 Diabetes Treated With Dapagliflozin in Conjunction With Insulin
Study Details
Study Description
Brief Summary
Real-world data can supplement the knowledge gained from traditional randomized controlled trials. To date, only a couple of studies (Andrew et al. 2014 and Wilding et al. 2015) have been conducted assessing the use of dapagliflozin in the real-world clinical settings in the United Kingdom and no research has been done on the use of dapagliflozin in Canadian clinical practice settings.
To the investigators' knowledge, no real-world study exits assessing the impact of using dapagliflozin in conjunction with insulin in people with type 2 diabetes mellitus on dosage and frequency of insulin, oral antiglycemic agents and hypertension drugs. This study will use an electronic medical record-based data that contains demographic, drug coverage, vitals, lab results, medical problems and diabetes-related complications, and medication prescription information of patients with diabetes received care from all outpatient diabetes clinics in London Ontario, Canada to assess the impact of using dapagliflozin in conjunction with insulin in patients with type 2 diabetes mellitus on health outcomes, and medications dosing and frequency.
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Detailed Description
Adult individuals (age≥18) with type 2 diabetes mellitus receiving care at the diabetes outpatient clinics at St. Joseph's Health Centre London (Canada) who have been treated with dapagliflozin in conjunction with insulin therapy will be selected from the Web DR researchable database for this study. Web DR is a diabetes-specific, web-based, researchable, electronic medical record and database. With no existing electronic medical record tailored for diabetes patients, the system was designed and implemented by the Centre for Diabetes, Endocrinology and Metabolism of St. Joseph's Health Care London. The St. Joseph's Centre for Diabetes, Endocrinology and Metabolism is the primary regional center for diabetes and endocrine disease management in Southwestern Ontario. Web DR is an electronic medical record with clinician-friendly pick-lists to enable structured electronic medical record data collection at the point of care, and is currently being used by 14 Endocrinologists and three Family Physician Diabetologists in the outpatient diabetes clinics at St. Joseph's Health Care London, Canada.
The baseline period will be 6 months to allow for more complete observation of comorbidities and medication use patterns. HbA1c, lipid, blood pressure, weight and other clinical indicators measured during the baseline period (closest to the date of dapagliflozin prescription) and follow-up period (3 and 6 months after prescription of dapagliflozin) will be extracted from the database. The last clinical value within the follow-up period and ≥30 days after the start of the medication data will be selected as follow-up information.
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 dapagliflozin and its impact on clinical outcomes.
Study Design
Outcome Measures
Primary Outcome Measures
- change in HbA1c value [baseline and 6 months]
mean change in HbA1c value at 6 months from baseline
Secondary Outcome Measures
- change in weight (kg) [baseline and 6 months]
mean change in weight at 6 months from baseline will be assessed
- change in blood pressure (systolic and diastolic) [baseline and 6 months]
mean change in blood pressure at 6 months from baseline will be assessed
- change in glomerular filtration rate [baseline and 6 months]
mean change in glomerular filtration rate at 6 months from baseline will be assessed
- change in Insulin dose [baseline and 6 months]
change in Insulin dose (units) at 6 months from baseline will be assessed
- Evidence of diabetic ketoacidosis documented [within the first 6 months from baseline]
Number of evidence of diabetic ketoacidosis within the first 6 months from baseline will be assessed
- Evidence of genital infections documented [within the first 6 months from baseline]
Evidence of genital infections within the first 6 months from baseline will be assessed
- Evidence of hypoglycemia events documented [within the first 6 months from baseline]
Number of hypoglycemia events documented within the first 6 months will be assessed
- Evidence of urinary tract infection (UTI) documented [within the first 6 months from baseline]
Evidence of urinary tract infection (UTI)s documented within the first 6 months will be assessed
Eligibility Criteria
Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus >18 years of age, diabetes patients on insulin who initiated dapagliflozin due to a need of tighter glycemic control
Exclusion Criteria:
- glomerular filtration rate (GFR)<60, pregnancy, type 1
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lawson Health Research Institute
- AstraZeneca
Investigators
- Principal Investigator: Stewart Harris, MD,MPH,FCFP, Lawson Research and Western University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESR-15-11696