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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

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 more

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951

15%

Cardiac failure

Hypertension

Hypotension

Urinary tract infection

Renal impairment

Hyperkalaemia

Fall

Atrial fibrillation

Diabetes mellitus

Hyperuricaemia

Anaemia

Acute kidney injury

Pneumonia

COVID-19

Death

Acute myocardial infarction

Cardiac failure congestive

Basal cell carcinoma

Cardiac failure chronic

Cellulitis

Syncope

Chronic kidney disease

COVID-19 pneumonia

Ischaemic stroke

Coronary artery disease

Chronic obstructive pulmonary disease

Myocardial infarction

Sepsis

Transient ischaemic attack

Angina unstable

Cerebrovascular accident

Angina pectoris

Ventricular tachycardia

100%

80%

60%

40%

20%

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

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