← Trials/Trial dossier/NCT06387199
SEMA SMA
RecruitingPhase 2, PHASE3Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide
Alleviating Carbohydrate Counting Using Weekly Subcutaneous Semaglutide Injections in People with Type 1 Diabetes on Closed-Loop Insulin Therapy: a 2x4 Factorial Randomized Placebo-Controlled Trial
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
26
estimated
Study population
Type 1 diabetes
Key I/E criterion
—
Primary endpoint
•CGM time-in-range
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. At least 18 years of age
2. A clinical diagnosis of T1D for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required)
3. Minimum 3-month use of a commercial advanced automated insulin delivery system. 4.4. Agreement to use an effective method of birth control for individuals with child-bearing potential. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.
Exclusion criteria
1. Use of GLP1-RAs within the last 4 weeks.
2. Use of any anti-hyperglycemic agent other than insulin within the last 2 weeks.
3. Planned or ongoing pregnancy
4. Breastfeeding
5. Severe hypoglycemic episode within the last 3 months, defined as an event where glucose was < 4 mmol/L resulting in seizure, loss of consciousness, or need to present to the emergency department
6. Severe diabetic ketoacidosis (DKA) within the last 6 months ("severe" referring to need to present to medical attention and requirement of intravenous insulin)
7. Prior history of acute pancreatitis, chronic pancreatitis, or gallbladder disease
8. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
9. Severe impairment of renal function with eGFR <30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months
10. Clinically significant diabetic retinopathy or gastroparesis, as per the clinical judgment of the investigator
11. Bariatric surgery within the last 6 months.
12. A serious medical or psychiatric illness that is likely to interfere with study participation as per the judgment of the investigator (e.g. cirrhosis, active cancer, decompensated schizophrenia).
13. Body mass index ≤ 21 kg/m2
14. Inability or unwillingness to comply to safe diabetes management in the view of the study group (e.g. inappropriate treatment of hypoglycemia or lack thereof)
15. Concern for safety of the participant, as per the clinical judgment of the primary investigator
Endpoints (21)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
4 endpointsMeasure of body weight
Time frame:24 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Measure of body mass index
Time frame:24 weeks
descriptive
Measure of waist circumference and hip circumference
Time frame:24 weeks
Waist circumference, change
change from baseline, improvement
Measure of waist-to-hip ratio
Time frame:24 weeks
ratio, improvement
Glycemic / diabetes
10 endpointsPercentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo)
Time frame:24 weeks
CGM time-in-range
descriptive, improvement
Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L
Time frame:24 weeks
CGM time-in-range
percent change from baseline, improvement
Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L
Time frame:24 weeks
CGM time-below-range
percent change from baseline, improvement
Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L
Time frame:24 weeks
CGM time-above-range
percent change from baseline, improvement
Mean glucose level
Time frame:24 weeks
descriptive, improvement
Standard deviation of glucose levels as a measure of glucose variability
Time frame:24 weeks
descriptive
Percentage coefficient of variation of glucose levels
Time frame:24 weeks
descriptive
Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70%
Time frame:24 weeks
CGM time-in-range
threshold achievement, improvement
Glycated hemoglobin (HbA1c)
Time frame:24 weeks
descriptive
LOINC 4548-4
Area under the curve 0-2h post meal, 0-3h post peal
Time frame:24 weeks
descriptive
Renal / kidney
1 endpointUrine albumin-creatinine ratio
Time frame:24 weeks
uACR, change
ratio, improvement
LOINC 9318-7
Cardiometabolic biomarkers
3 endpointsHeart rate
Time frame:24 weeks
Heart rate, change
change from baseline, improvement
Blood pressure
Time frame:24 weeks
descriptive, improvement
Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides
Time frame:24 weeks
change from baseline, improvement
Patient-reported / QoL
3 endpointsAverage scores between interventions on the Type 1 Diabetes Distress Scale questionnaire
Time frame:24 weeks
descriptive
Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire
Time frame:24 weeks
change from baseline, improvement
Average scores between interventions based on the Hypoglycemic Fear Survey - II
Time frame:24 weeks
descriptive, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.