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

NCT02899949 | Completed

• 1 other identifier: ESR-15-11696
• Study Type: observational
• Target: 212
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

dapagliflozin; type 2 diabetes; real-world data

Outcome Measures

Primary Outcomes (1)

• change in HbA1c value

  mean change in HbA1c value at 6 months from baseline

  baseline and 6 months

Secondary Outcomes (8)

• change in weight (kg)

  baseline and 6 months

• change in blood pressure (systolic and diastolic)

  baseline and 6 months

• change in glomerular filtration rate

  baseline and 6 months

• change in Insulin dose

  baseline and 6 months

• Evidence of diabetic ketoacidosis documented

  within the first 6 months from baseline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Type 2 diabetes mellitus \>18 years of age, diabetes patients on insulin who initiated dapagliflozin due to a need of tighter glycemic control

You may not qualify if:

• glomerular filtration rate (GFR)\<60, pregnancy, type 1

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• AstraZeneca: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stewart Harris, MD,MPH,FCFP

  Lawson Research and Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share