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

NCT ID: NCT02899949

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 212 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Stewart Harris

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stewart Harris, MD,MPH,FCFP

Role: PRINCIPAL_INVESTIGATOR

Lawson Research and Western University

Other Identifiers

ESR-15-11696

Identifier Type: -

Identifier Source: org_study_id