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Empagliflozin 2.5 mg + closed-loop insulin system for Type 1 Diabetes (CL-LoDE Trial)

Phase 1
Waitlist Available
Led By Michael Tsoukas, MD
Research Sponsored by McGill University
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 10 days
Awards & highlights

CL-LoDE Trial Summary

A closed-loop insulin system, also referred to as the "artificial pancreas" (AP), is made up of an insulin pump, a continuous glucose monitor, and an application communicating between the two to adjust insulin administration based on glucose control. This is meant for the treatment of type 1 diabetes. The McGill Artificial Pancreas (MAP) has been used previously in type 1 diabetes with significant benefits. Though prior studies have shown significant benefit with this system, some challenges still exist. Empagliflozin is used in type 2 diabetes; it allows for glucose to be removed through the urine. Though its use is not approved in type 1 diabetes in North America, it (along with similar drugs) has been used in studies as adjunctive therapy with insulin with benefits on blood sugar control. The purpose of our study is to see if a small dose of empagliflozin (2.5 mg and 5 mg) is enough to help those who cannot achieve adequate glucose control on a closed-loop insulin system. The primary hypotheses of the study are the following: The use of empagliflozin 2.5 mg daily will increase time in range compared to placebo for those on the closed-loop system. The use of empagliflozin 5 mg daily will increase time in range compared to placebo for those on the closed-loop system.

Eligible Conditions
  • Type 1 Diabetes

CL-LoDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

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 plasma glucose levels spent in target range (placebo vs empagliflozin 2.5 mg)
Percentage of time of plasma glucose levels spent in target range (placebo vs empagliflozin 5 mg)
Secondary outcome measures
Average glucose level
Average point-of-care ketone level per intervention
Percentage coefficient of variation of glucose levels
+8 more

CL-LoDE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Empagliflozin 5 mg + closed-loop insulin systemExperimental Treatment1 Intervention
Group II: Empagliflozin 2.5 mg + closed-loop insulin systemExperimental Treatment1 Intervention
Group III: Placebo + closed-loop insulin systemActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
14-day outpatient intervention
2020
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor
394 Previous Clinical Trials
998,356 Total Patients Enrolled
Michael Tsoukas, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
4 Previous Clinical Trials
125 Total Patients Enrolled
Melissa-Rosina Pasqua, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
1 Previous Clinical Trials
46 Total Patients Enrolled

Frequently Asked Questions

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~6 spots leftby Apr 2025