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

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ClinicalTrials.gov Identifier: NCT02899949
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Stewart Harris, Lawson Health Research Institute

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.


Condition or disease
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
Actual Enrollment : 212 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Data on Dapagliflozin: Characteristics and Health Outcomes of Patients With Type 2 Diabetes Treated With Dapagliflozin in Conjunction With Insulin
Actual Study Start Date : October 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. change in HbA1c value [ Time Frame: baseline and 6 months ]
    mean change in HbA1c value at 6 months from baseline


Secondary Outcome Measures :
  1. change in weight (kg) [ Time Frame: baseline and 6 months ]
    mean change in weight at 6 months from baseline will be assessed

  2. change in blood pressure (systolic and diastolic) [ Time Frame: baseline and 6 months ]
    mean change in blood pressure at 6 months from baseline will be assessed

  3. change in glomerular filtration rate [ Time Frame: baseline and 6 months ]
    mean change in glomerular filtration rate at 6 months from baseline will be assessed

  4. change in Insulin dose [ Time Frame: baseline and 6 months ]
    change in Insulin dose (units) at 6 months from baseline will be assessed

  5. Evidence of diabetic ketoacidosis documented [ Time Frame: within the first 6 months from baseline ]
    Number of evidence of diabetic ketoacidosis within the first 6 months from baseline will be assessed

  6. Evidence of genital infections documented [ Time Frame: within the first 6 months from baseline ]
    Evidence of genital infections within the first 6 months from baseline will be assessed

  7. Evidence of hypoglycemia events documented [ Time Frame: within the first 6 months from baseline ]
    Number of hypoglycemia events documented within the first 6 months will be assessed

  8. Evidence of urinary tract infection (UTI) documented [ Time Frame: within the first 6 months from baseline ]
    Evidence of urinary tract infection (UTI)s documented within the first 6 months will be assessed



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899949


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

Responsible Party: Stewart Harris, Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02899949     History of Changes
Other Study ID Numbers: ESR-15-11696
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stewart Harris, Lawson Health Research Institute:
dapagliflozin
type 2 diabetes
real-world data

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases