Health Outcomes of Patients With Type 2 Diabetes Treated With Dapagliflozin in Conjunction With Insulin

Real-world Data on Dapagliflozin: Characteristics and Health Outcomes of Patients With Type 2 Diabetes Treated With Dapagliflozin in Conjunction With Insulin

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

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 Type: Observational
• Enrollment (Actual): 212

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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 dapagliflozin in conjunction with insulin therapy will be selected for this study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in HbA1c value	mean change in HbA1c value at 6 months from baseline	baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in weight (kg)	mean change in weight at 6 months from baseline will be assessed	baseline and 6 months
change in blood pressure (systolic and diastolic)	mean change in blood pressure at 6 months from baseline will be assessed	baseline and 6 months
change in glomerular filtration rate	mean change in glomerular filtration rate at 6 months from baseline will be assessed	baseline and 6 months
change in Insulin dose	change in Insulin dose (units) at 6 months from baseline will be assessed	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	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	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	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	within the first 6 months from baseline

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Stewart Harris, MD,MPH,FCFP, Lawson Research and Western University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 6, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: type 2 diabetes; dapagliflozin; real-world data
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ESR-15-11696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No