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SGLT2 Inhibitor
Empagliflozin 2.5 mg daily for Type 1 Diabetes
Phase 4
Recruiting
Led By Melissa-Rosina Pasqua, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Study Summary
This trial aims to see if taking empagliflozin along with an automated insulin delivery system can help improve blood sugar control in people with type 1 diabetes who are not meeting their target glucose
Who is the study for?
Adults over 18 with type 1 diabetes for at least a year, using an automated insulin delivery system for 3+ months but not meeting glucose control targets. They must agree to effective birth control if of child-bearing age.Check my eligibility
What is being tested?
The trial is testing whether adding Empagliflozin (2.5 mg daily) to current AID systems helps adults with type 1 diabetes stay within their target blood sugar range better than a placebo does over a period of 26 weeks.See study design
What are the potential side effects?
Empagliflozin may cause urinary tract infections, dehydration, low blood pressure, ketoacidosis (a serious diabetic complication), and genital yeast infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of time of glucose levels spent in the target range (empagliflozin vs placebo)
Secondary outcome measures
Average scores between interventions based on Diabetes Treatment Satisfaction Questionnaire
Average scores between interventions based on Hypoglycemic Fear Survey - II
Average scores between interventions based on Type 1 Diabetes Distress Scale Questionnaire
+19 moreSide effects data
From 2021 Phase 3 trial • 5988 Patients • NCT0305795115%
Cardiac failure
7%
Hypertension
7%
Urinary tract infection
7%
Hypotension
6%
Hyperkalaemia
6%
Fall
6%
Renal impairment
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Anaemia
4%
Hyperuricaemia
3%
Acute kidney injury
3%
Pneumonia
2%
Acute myocardial infarction
2%
COVID-19
2%
Cardiac failure congestive
2%
Death
1%
Myocardial infarction
1%
Cardiac failure chronic
1%
Angina pectoris
1%
Angina unstable
1%
Ventricular tachycardia
1%
COVID-19 pneumonia
1%
Cellulitis
1%
Sepsis
1%
Chronic kidney disease
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Basal cell carcinoma
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Empagliflozin 2.5 mg dailyExperimental Treatment1 Intervention
Empagliflozin is a sodium/glucose cotransporter 2 inhibitor (SGLT2i) that inhibits glucose reabsorption in the kidney. In this study, a capsule of empagliflozin 2.5 mg will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks.
Group II: PlaceboActive Control1 Intervention
As a control, a placebo capsule will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
2017
Completed Phase 4
~181750
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
446 Previous Clinical Trials
159,680 Total Patients Enrolled
Diabetes CanadaOTHER
10 Previous Clinical Trials
1,061 Total Patients Enrolled
Melissa-Rosina Pasqua, MDPrincipal InvestigatorResearch Institute of the McGill University Health Centre
1 Previous Clinical Trials
25 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for participants in this clinical trial?
"As per clinicaltrials.gov, this medical research study is actively in the process of recruiting suitable candidates. The trial was initially listed on 1st March 2024 and its most recent update occurred on 7th March 2024."
Answered by AI
What is the upper limit of participants involved in this clinical study?
"Indeed, the information available on clinicaltrials.gov indicates that this research endeavor is presently seeking individuals to participate. Originally published on March 1st, 2024, with the most recent update made on March 7th of the same year, this investigation aims to enlist a total of 46 patients from one designated site."
Answered by AI
Has the 2.5 mg daily dose of Empagliflozin received approval from the FDA?
"Given that this investigation is classified as Phase 4 and the medication Empagliflozin at a daily dose of 2.5 mg has already received approval, our team rates its safety level at 3 on the scale provided."
Answered by AI
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