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SEMA-AP
CompletedPhase 2, PHASE3Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care
Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care: a Double-blind, Cross-over, Randomized Controlled Trial
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Assets
GLP-1 / incretin class catch-all / Semaglutide
Listed sites
1
Recruiting sites
—
Enrollment
28
actual
Study population
Type 1 diabetes
Key I/E criterion
•HbA1c ≤11%
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
Exclusion criteria
1. Current or < 2 week use of another GLP1-receptor agonist
2. Less than 2 weeks use of any anti-hyperglycemic agent other than insulin
3. Planned or ongoing pregnancy
4. Breastfeeding individuals
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 <15 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. History of bariatric surgery within 6 months of screening
12. Any serious medical or psychiatric illness likely to interfere with study participation as per the judgment of the investigator (e.g. cirrhosis, active cancer, decompensated schizophrenia)
13. Prior adverse reaction to GLP1-RAs
14. Body mass index ≤ 21 kg/m2
15. Regular use of hydroxyurea during the expected time of Dexcom G6 use, as this medication is known to cause inaccurate measurements (43)
16. Failure to comply to the study protocol and/or research group's recommendations (e.g. change in pump parameters, ketone measurement)
17. 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)
18. Any demonstrate of difficulty in using the iMAP system following training, as per investigator's judgment
19. Concern for safety of the participant, as per the clinical judgment of the primary investigator
**Note that for reasons of medicolegal protection for medical supervision, participants must be Canadian residents.**
Endpoints (16)
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
1 endpointMeasured of body mass: weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio
Time frame:15 weeks
descriptive
Glycemic / diabetes
10 endpointsPercentage of time of plasma glucose levels spent in target range (semaglutide vs placebo)
Time frame:4 weeks
CGM time-in-range
descriptive, improvement
Percentage of time spent in the following ranges of glucose levels between 3.9 and 7.8 mmol/L
Time frame:4 weeks
CGM time-in-range
threshold achievement, improvement
Percentage of time spent in the following ranges of glucose levels: below 3.9 and 3.0 mmol/L
Time frame:4 weeks
CGM time-below-range
percent change from baseline, improvement
componentscgm time below range <3.9mmol/L, cgm time below range <3.0mmol/L
Percentage of time spent in the following ranges of glucose levels: above 7.8, 10, and 13.9 mmol/L
Time frame:4 weeks
CGM time-above-range
descriptive, improvement
Mean glucose level
Time frame:4 weeks
descriptive, improvement
Standard deviation of glucose levels as a measure of glucose variability
Time frame:4 weeks
descriptive
Percentage coefficient of variation of glucose levels
Time frame:4 weeks
descriptive
Proportion of participants with TIR between 3.9 - 10.0 mol/L ≥ 70%
Time frame:4 weeks
CGM time-in-range
threshold achievement, improvement
Glycated hemoglobin
Time frame:15 weeks
descriptive, improvement
LOINC 4548-4
Glucagon, C-peptide, Paracetamol absorption after mixed meal tolerance test (in first 15 participants)
Time frame:15 weeks
descriptive
Renal / kidney
1 endpointUrine albumin-creatinine ratio
Time frame:15 weeks
uACR, change
ratio, improvement
LOINC 9318-7
Cardiometabolic biomarkers
2 endpointsBlood pressure and heart rate
Time frame:15 weeks
change from baseline, improvement
Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides
Time frame:15 weeks
descriptive, improvement
Patient-reported / QoL
1 endpointAverage scores between interventions based on quality of life questionnaires
Time frame:15 weeks
descriptive, improvement
Other (unclassified)
1 endpointBiochemical analyses (exploratory)
Time frame:15 weeks
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Nature medicine2025 Apr (month)PMID39794615doi:10.1038/s41591-024-03463-zvia clinicaltrials gov reference derived + pubmed nct search
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.