A Phase 4 interventional study of Empagliflozin and Placebo in Type 1 Diabetes, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 4, Interventional, and Treatment
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 46 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 420 studies on the registry; 106 are open to participants now.
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Exclusion Criteria:
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
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
26-week use of automated insulin delivery system with empagliflozin (2.5 mg daily) in individuals with suboptimal time in range.
26-week use of automated insulin delivery system with placebo (daily) in individuals with suboptimal time in range.
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.
Time frame: 4 weeks
Percentage of time spent in the glucose range between 3.9 and 7.8 mmol/L
Percent as per CGM data
Time frame: 4 weeks
Percentage of time spent in the glucose range below 3.9 mmol/L and 3.0 mmol/L
Percent as per CGM data
Time frame: 4 weeks
Percentage of time spent in the glucose range above 10.0 mmol/L and 13.9 mmol/L
Percent as per CGM data
Time frame: 4 weeks
Mean glucose levels
Defined as per CGM data, in mmol/L
Time frame: 4 weeks
Standard deviation of glucose levels
Defined as per CGM data, in mmol/L
Time frame: 4 weeks
Coefficient of variance of glucose levels
Percent as per CGM data
Time frame: 4 weeks
Total insulin delivery (overall, basal, and bolus)
Defined as per participant's pump data
Time frame: 4 weeks
Mean daily carbohydrate intake
Defined as per participant's pump data
Time frame: 4 weeks
HbA1c
Percent as per blood test
Time frame: 26 weeks
Estimated glomerular filtration rate (eGFR)
mL/min/1.73 m\^2 as per blood test
Time frame: 26 weeks
Lipid profile
Includes measurements in mmol/L as per blood test: total cholesterol, triglycerides, HDL-C, LDL-C, nonHDL-C
Time frame: 26 weeks
Brain Natriuretic Peptide (NT-pro-BNP)
ng/L as per blood test
Time frame: 26 weeks
Liver profile - bilirubin
umol/L as per blood test
Time frame: 26 weeks
Liver profile - alanine transaminase (ALT) and alkaline phosphatase (ALP)
U/L as per blood test
Time frame: 26 weeks
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.
Time frame: 26 weeks
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.
Time frame: 26 weeks
Heart rate
Body measurement as described (beats per minutes)
Time frame: 26 weeks
Blood pressure
Body measurement as described (diastolic and systolic pressure; mmHg)
Time frame: 26 weeks
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.
Time frame: 26 weeks
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.
Time frame: 26 weeks
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.
Time frame: 26 weeks
Fasting ketone levels
As per ketone test strip and meter; measured by participant
Time frame: 7 days
Plan to share: 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.
Supporting information: Informed consent form
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Empagliflozin
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