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

NCT06021145 | Recruiting Phase 4

• 1 other identifier: 2024-9953
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

diabetes; empagliflozin; 26-week

Outcome Measures

Primary Outcomes (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.

  4 weeks

Secondary Outcomes (22)

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

  4 weeks

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

  4 weeks

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

  4 weeks

• Mean glucose levels

  4 weeks

• Standard deviation of glucose levels

  4 weeks

Study Arms (2)

Empagliflozin 2.5 mg daily

EXPERIMENTAL

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.

Drug: Empagliflozin

Placebo

ACTIVE COMPARATOR

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

Drug: Placebo

Interventions

Empagliflozin DRUG

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

Empagliflozin 2.5 mg daily

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Diabetes Canada: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Melissa-Rosina Pasqua, MD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adelyn Moore

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 1, 2023
• Study Start: April 2, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

CA (1)