Recruiting

Empagliflozin & AID

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT06021145

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin

Placebo

Study Details

Brief summary:

The goal of this 26-week multicenter, randomized, parallel, placebo-controlled trial is to test the effectiveness of empagliflozin use in conjunction with automated insulin delivery (AID) to improve glucose control in individuals with type 1 diabetes who do not meet target recommendations for time in range (3.9-10.0 mmol/L). The main question it aims to answer is:

- Will use of empagliflozin (2.5 mg/day) increase time spent in the target range of 3.9 to 10.0 mmol/L compared to placebo for individuals on an AID system who do not meet glycemic targets?

Participants will either take 2.5 mg of empagliflozin or a placebo daily for 26 weeks while remaining on their current AID system.

Conditions

Type 1 Diabetes

Study ID

NCT06021145

Start date

Apr 2, 2024

Status verified date

Aug, 2024

Completion date

May, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals ≥ 18 years of age.
  • A clinical diagnosis of type 1 diabetes for at least one year, as per the investigators' clinical judgment (confirmatory C-peptide and antibodies will not be required).
  • Minimum 3-month use of a commercial advanced AID system.
  • Time in range (3.9 to 10.0 mmol/L) < 70% on their personal AID system in the 30 days prior to screening (with minimum 70% time spent in closed-loop mode).
  • Agreement to use a highly effective method of birth control for individuals of child-bearing age and active avoidance of pregnancy during the trial. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a disclosed medical condition causing sterility (ex: hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.

Exclusion Criteria:

  • Current or ≤ 2 week use of any anti-hyperglycemic agent other than insulin (such as SGTL2i).
  • Current or ≤ 1 month use of Glucagon-like Peptide 1 (GLP1)-Receptor Agonists.
  • Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.
  • Planned or ongoing very low carbohydrate diet (< 50g/day).
  • Glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as per CKD-EPI formula with creatinine levels measured within the last 12 months.
  • Use of hydroxyurea.
  • Planned or ongoing pregnancy.
  • Breastfeeding.
  • Ongoing active risk of recurrent genito-urinary infections, as per the clinical judgement of the investigators.
  • Severe hypoglycemic episode within 1 month of screening, defined as an event resulting in seizure, loss of consciousness, or need to present to the emergency department.
  • Diabetic ketoacidosis within 6 months of screening, defined as an event requiring the need to present to medical attention and administration of intravenous insulin.
  • Any serious medical illness likely to interfere with the ability to complete the trial per the judgment of the investigators.
  • Clinically significant retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event (ex: acute coronary syndrome or cardiac surgery).
  • Prior serious reaction to SGLT2i.
  • Use of the Medtronic 670G or 770G system in the last 30 days.
  • In the opinion of the investigator, inability to observe the contraindications of the study drugs, or failure to comply to the study protocol or research team's recommendations (e.g., changing pump parameters, ketone measurements).

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empagliflozin 2.5 mg daily

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.

active comparator: Placebo

As a control, a placebo capsule will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks.

Interventions

Empagliflozin

26-week use of automated insulin delivery system with empagliflozin (2.5 mg daily) in individuals with suboptimal time in range.

Placebo

26-week use of automated insulin delivery system with placebo (daily) in individuals with suboptimal time in range.

Primary outcome measure

  • Percentage of time of glucose levels spent in the target range (empagliflozin vs placebo) [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Adelyn Moore

(438) 866-4807adelyn.moore@mail.mcgill.ca

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Adelyn Moore

4388664807adelyn.moore@mail.mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Keywords

  • diabetes
  • empagliflozin
  • 26-week

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-08-09.