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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899949
• Other study ID #: ESR-15-11696
• Status: Completed
• Phase: N/A
• First received: September 9, 2016
• Last updated: March 6, 2017
• Start date: October 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in HbA1c value	mean change in HbA1c value at 6 months from baseline	baseline and 6 months
Secondary	change in weight (kg)	mean change in weight at 6 months from baseline will be assessed	baseline and 6 months
Secondary	change in blood pressure (systolic and diastolic)	mean change in blood pressure at 6 months from baseline will be assessed	baseline and 6 months
Secondary	change in glomerular filtration rate	mean change in glomerular filtration rate at 6 months from baseline will be assessed	baseline and 6 months
Secondary	change in Insulin dose	change in Insulin dose (units) at 6 months from baseline will be assessed	baseline and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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