Your session is about to expire
← Back to Search
SGLT2 Inhibitor
Empagliflozin 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
Drug Has Already Been Approved
Pivotal Trial
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of time of glucose levels spent in the target range (empagliflozin vs placebo)
Secondary study objectives
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%
Hypotension
7%
Hypertension
7%
Urinary tract infection
6%
Renal impairment
6%
Hyperkalaemia
6%
Fall
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Hyperuricaemia
4%
Anaemia
3%
Acute kidney injury
3%
Pneumonia
2%
COVID-19
2%
Death
2%
Acute myocardial infarction
2%
Cardiac failure congestive
1%
Basal cell carcinoma
1%
Cardiac failure chronic
1%
Cellulitis
1%
Syncope
1%
Chronic kidney disease
1%
COVID-19 pneumonia
1%
Ischaemic stroke
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Myocardial infarction
1%
Sepsis
1%
Transient ischaemic attack
1%
Angina unstable
1%
Cerebrovascular accident
1%
Angina pectoris
1%
Ventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
471 Previous Clinical Trials
166,911 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
2 Previous Clinical Trials
41 Total Patients Enrolled