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Type 1 DiabetesPhase 4NCT06021145

Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes

A Phase 4 study testing Empagliflozin in people with Type 1 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteCanada
Study dates
2 Apr 2024to May 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

Adelyn Moore contact

(438) 866-4807

adelyn.moore@mail.mcgill.ca

Canada1 site, 1 recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Adelyn Moore, 4388664807, adelyn.moore@mail.mcgill.ca

    Recruiting

Other trials in Canada

About this study

Official title: Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes: a Randomized Controlled Parallel Trial

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
Being tested
Empagliflozin, Placebo
Keywords
diabetes, empagliflozin, 26-week
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

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

  • PlaceboDrug

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

Study groups in NCT06021145
Study groupRoleWhat they receive
Empagliflozin 2.5 mg dailyExperimentalEmpagliflozin 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.
Receives: Drug: Empagliflozin
PlaceboActive comparatorAs a control, a placebo capsule will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of time of glucose levels spent in the target range (empagliflozin vs placebo)

    Target range is defined to be between 3.9 and 10.0 mmol/L of placebo on an automated insulin delivery system vs empagliflozin (2.5 mg) on an automated insulin delivery system. Percent measured as per continuous glucose monitor (CGM) data.

    Measured: 4 weeks

Secondary outcomes (22)

  1. Percentage of time spent in the glucose range between 3.9 and 7.8 mmol/L

    Percent as per CGM data

    Measured: 4 weeks

  2. Percentage of time spent in the glucose range below 3.9 mmol/L and 3.0 mmol/L

    Percent as per CGM data

    Measured: 4 weeks

  3. Percentage of time spent in the glucose range above 10.0 mmol/L and 13.9 mmol/L

    Percent as per CGM data

    Measured: 4 weeks

  4. Mean glucose levels

    Defined as per CGM data, in mmol/L

    Measured: 4 weeks

  5. Standard deviation of glucose levels

    Defined as per CGM data, in mmol/L

    Measured: 4 weeks

  6. Coefficient of variance of glucose levels

    Percent as per CGM data

    Measured: 4 weeks

  7. Total insulin delivery (overall, basal, and bolus)

    Defined as per participant's pump data

    Measured: 4 weeks

  8. Mean daily carbohydrate intake

    Defined as per participant's pump data

    Measured: 4 weeks

  9. HbA1c

    Percent as per blood test

    Measured: 26 weeks

  10. Estimated glomerular filtration rate (eGFR)

    mL/min/1.73 m^2 as per blood test

    Measured: 26 weeks

  11. Lipid profile

    Includes measurements in mmol/L as per blood test: total cholesterol, triglycerides, HDL-C, LDL-C, nonHDL-C

    Measured: 26 weeks

  12. Brain Natriuretic Peptide (NT-pro-BNP)

    ng/L as per blood test

    Measured: 26 weeks

  13. Liver profile - bilirubin

    umol/L as per blood test

    Measured: 26 weeks

  14. Liver profile - alanine transaminase (ALT) and alkaline phosphatase (ALP)

    U/L as per blood test

    Measured: 26 weeks

  15. Measurement of body mass: weight and height

    Body measurement as described (weight in kilograms and height in meters). Weight and height will be combined to report body mass index in kg/m^2.

    Measured: 26 weeks

  16. Waist and hip circumference, and waist-to-hip ratio

    Body measurements as described (waist and hip circumference in centimeters). Waist and hip cirumference will be combined to report waist-to-hip ratio.

    Measured: 26 weeks

  17. Heart rate

    Body measurement as described (beats per minutes)

    Measured: 26 weeks

  18. Blood pressure

    Body measurement as described (diastolic and systolic pressure; mmHg)

    Measured: 26 weeks

  19. Average scores between interventions based on Type 1 Diabetes Distress Scale Questionnaire

    Self-report scale (1 min = "not a problem" to 6 max = "a very serious problem") that assesses a participant's distress surrounding their diabetes with higher scores correlating to higher distress.

    Measured: 26 weeks

  20. Average scores between interventions based on Hypoglycemic Fear Survey - II

    Likert scale (1 min to 5 max) that assesses a participant's worry surrounding hypoglycemia with higher scores indicating increased fear of hypoglycemia.

    Measured: 26 weeks

  21. Average scores between interventions based on Diabetes Treatment Satisfaction Questionnaire

    Self-report scale (0 min = "very dissatisfied" to 6 max = "very satisfied") that assesses a participant's satisfaction surrounding the treatment for their diabetes with higher scores indicating greater satisfaction with treatment.

    Measured: 26 weeks

  22. Fasting ketone levels

    As per ketone test strip and meter; measured by participant

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2023
  2. Study start2 Apr 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06021145
Sponsor's protocol ID
2024-9953
Status last verified
Aug 2024
First submitted
21 Aug 2023
Last updated
9 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The raw data (that is, insulin delivery, glucose levels and individual participant data) and informed consent form will be shared by the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the McGill University Health Center's Research Ethics Board. All data shared will be de-identified. Raw data will be shared for non-commercial use upon reasonable request and a material transfer agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin in people with Type 1 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Adelyn Moore ((438) 866-4807, adelyn.moore@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time of glucose levels spent in the target range (empagliflozin vs placebo) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06021145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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