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Trial · Interventional

CompletedPhase 2/3Registry data

Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care

Short name SEMA-AP

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
28 participants (actual)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · Other
Design
Randomized · Triple masking
Countries
1 country

Canada

Start
2 Oct 2022
Primary completion
15 Apr 2024
Completion
30 Jun 2024
First posted
25 Jan 2022
Last update posted
22 Jan 2025
Conditions
Type 1 Diabetes · Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 2/3

    SEMA-AP

    NCT05205928

    2 Oct 2022 to 30 Jun 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

A closed-loop insulin system, also referred to as the "artificial pancreas" (AP), is made up of an insulin pump, a continuous glucose monitor, and an application communicating between the two to adjust insulin administration based on glucose control. This is meant for the treatment of type 1 diabetes. The McGill Artificial Pancreas (MAP) has been used previously in type 1 diabetes with significant benefits. Though prior studies have shown significant benefit with this system, some challenges still exist. Semaglutide is used in type 2 diabetes and obesity; it is a once-weekly injectable medication that increases levels of a gut hormone called Glucagon-Like Peptide-1, which modifies gastric emptying, suppresses glucagon, and suppresses appetite. Though its use is not approved in type 1 diabetes in North America, it (along with similar drugs) has been used in studies as adjunctive therapy with insulin with benefits on blood sugar control. Similar medications have been used in type 1 diabetes (such as liraglutide and exenatide), but are not as strong in glucose effect even in type 2 diabetes as compared with semaglutide. The purpose of our study is to see if semaglutide administered weekly at the maximum tolerated dose in those with type 1 diabetes will have improved glucose control (as per time in target range from continuous glucose monitoring data) compared to placebo, while using a closed-loop insulin system.

Interventions

  • Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapyDrug

Arms2

  • Active comparator

    Placebo + closed-loop insulin system

  • Experimental

    Semaglutide, Ozempic® (at maximum tolerated dose) + closed-loop insulin system

    Semaglutide is a Glucagon-Like Peptide 1 Receptor Agonist. It stimulates GLP1 in the body, which allows for increased satiety, reduced glucagon levels, delayed gastric emptying, and in some, increased insulin secretion. It is a once per week subcutaneous injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 4 weeks

    Registry description

    Target range is defined to be between 3.9 and 10.0 mmol/L of placebo on closed-loop system vs semaglutide (at maximal tolerated dose) on closed-loop insulin system.

Secondary outcomes(15)
  1. Percentage of time spent in the following ranges of glucose levels between 3.9 and 7.8 mmol/L

    Time frame · 4 weeks

    Registry description

    % as per CGM data

  2. Percentage of time spent in the following ranges of glucose levels: below 3.9 and 3.0 mmol/L

    Time frame · 4 weeks

    Registry description

    % as per CGM data

  3. Percentage of time spent in the following ranges of glucose levels: above 7.8, 10, and 13.9 mmol/L

    Time frame · 4 weeks

    Registry description

    % as per CGM data

  4. Mean glucose level

    Time frame · 4 weeks

    Registry description

    Defined as per CGM data, in mmol/L

  5. Standard deviation of glucose levels as a measure of glucose variability

    Time frame · 4 weeks

    Registry description

    Defined as per CGM data, in mmol/L

  6. Percentage coefficient of variation of glucose levels

    Time frame · 4 weeks

    Registry description

    % as per CGM data

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

    Time frame · 4 weeks

    Registry description

    As per CGM data

  8. Glycated hemoglobin

    Time frame · 15 weeks

    Registry description

    Blood test to assess control within last 3-4 months

  9. Average scores between interventions based on quality of life questionnaires

    Time frame · 15 weeks

    Registry description

    These include: Type 1 Diabetes Distress Scale, Hypoglycemic Fear Survey - II, INSPIRE questionnaire for adults, Diabetes Bowel Syndrome Questionnaire, Diabetes Treatment Satisfaction Questionnaire

  10. Blood pressure and heart rate

    Time frame · 15 weeks

    Registry description

    Body measurements as described (mmHg and beats per minutes)

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

    Time frame · 15 weeks

    Registry description

    Measurements done at visit - weight in kilograms, body mass index as per kg/m\^2, circumferences in cm

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

    Time frame · 15 weeks

    Registry description

    Blood tests, in mmol/L

  13. Biochemical analyses (exploratory)

    Time frame · 15 weeks

    Registry description

    CRP, ferritin, IL-6, Brain natriuretic peptide, TXNIP

  14. Urine albumin-creatinine ratio

    Time frame · 15 weeks

    Registry description

    Urine test

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

    Time frame · 15 weeks

    Registry description

    Test done where beverage given and subsequent blood tests done after.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

6 results

Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial.

Pasqua et al. 2025Nature medicinecited by 55

PMID 39794615PMC12003151DOI 10.1038/s41591-024-03463-zPUB-39794615

Free to read · publisher termsCC BY-NC-ND6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.\*\*

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