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NCT Number: NCT02899949

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. change in HbA1c value

    Time frame: baseline and 6 months

    mean change in HbA1c value at 6 months from baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 14, 2016
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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