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Tests treatment safety and results for Type 1 Diabetes
Official title Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes
ClinicalTrials.gov ID: NCT06021145
What this study is testing
What is Empagliflozin?
Empagliflozin is an investigational medicine, given as an once-daily, being studied as a potential treatment for type 1 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Agreement to use a highly effective method of birth control for individuals of child-bearing age and active avoidance of pregnancy during the trial...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.