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SEMA-AP

CompletedPhase 2, PHASE3

Weekly 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

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

NCT IDNCT05205928
Org study ID2022-8097

Timeline

Milestones

Study first posted2022-01-25actual
Study start2022-10-02actual
Primary completion2024-04-15actual
Study completion2024-06-30actual
Last update posted2025-01-22actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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)
Glycated hemoglobin (HbA1c) up to 11% (inclusive), performed within the last 6 months prior to study inclusion
Insulin pump use (of any modality) for minimum 3 months
Agreement to the use of highly effective method of birth control in persons of child-bearing age (if sexually active) and active avoidance of pregnancy during the trial. Child-bearing potential refers to participants of the female sex post-menarche and have not reached menopause or have a disclosed 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. 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

Glycemic / diabetes
10
Cardiometabolic biomarkers
2
Weight & body composition
1
Renal / kidney
1
Patient-reported / QoL
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Measured of body mass: weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio

Time frame:15 weeks

descriptive

Glycemic / diabetes

10 endpoints
Primary/protocol endpoint

Percentage of time of plasma glucose levels spent in target range (semaglutide vs placebo)

Time frame:4 weeks

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint/low confidence

Mean glucose level

Time frame:4 weeks

descriptive, improvement

Secondary/protocol endpoint

Standard deviation of glucose levels as a measure of glucose variability

Time frame:4 weeks

descriptive

Secondary/protocol endpoint/low confidence

Percentage coefficient of variation of glucose levels

Time frame:4 weeks

descriptive

Secondary/protocol endpoint

Proportion of participants with TIR between 3.9 - 10.0 mol/L ≥ 70%

Time frame:4 weeks

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Glycated hemoglobin

Time frame:15 weeks

descriptive, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Glucagon, C-peptide, Paracetamol absorption after mixed meal tolerance test (in first 15 participants)

Time frame:15 weeks

descriptive

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Urine albumin-creatinine ratio

Time frame:15 weeks

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Blood pressure and heart rate

Time frame:15 weeks

change from baseline, improvement

Secondary/protocol endpoint

Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides

Time frame:15 weeks

descriptive, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Average scores between interventions based on quality of life questionnaires

Time frame:15 weeks

descriptive, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Biochemical 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.