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Type 1 DiabetesPhase 2/3SEMA-APNCT05205928

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

A Phase 2/3 study testing Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy in people with Type 1 Diabetes and Diabetes Mellitus, Type 1, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes, Diabetes Mellitus, Type 1
What is being tested?
Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteCanada
Study dates
2 Oct 2022to 30 Jun 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Current or < 2 week use of another GLP1-receptor agonist
  • Less than 2 weeks use of any anti-hyperglycemic agent other than insulin
  • Planned or ongoing pregnancy
  • Breastfeeding individuals
  • 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
  • Severe diabetic ketoacidosis (DKA) within the last 6 months ("severe" referring to need to present to medical attention and requirement of intravenous insulin)
Show all 20Show fewer
  • Prior history of acute pancreatitis, chronic pancreatitis, or gallbladder disease
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
  • Severe impairment of renal function with eGFR <15 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months
  • Clinically significant diabetic retinopathy or gastroparesis, as per the clinical judgment of the investigator
  • History of bariatric surgery within 6 months of screening
  • 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)
  • Prior adverse reaction to GLP1-RAs
  • Body mass index ≤ 21 kg/m2
  • Regular use of hydroxyurea during the expected time of Dexcom G6 use, as this medication is known to cause inaccurate measurements (43)
  • Failure to comply to the study protocol and/or research group's recommendations (e.g. change in pump parameters, ketone measurement)
  • 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)
  • Any demonstrate of difficulty in using the iMAP system following training, as per investigator's judgment
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care: a Double-blind, Cross-over, Randomized Controlled Trial

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.

Being tested
Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy
Keywords
Insulin, Closed-loop system, GLP-1 receptor agonist, Semaglutide, Artificial Pancreas, Diabetes Mellitus, Type 1
Medical subject headings
Diabetes Mellitus, Type 1, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    The blinded drug will be used with participant's routine therapy (+ continuous glucose monitoring if not already in use) for 11 weeks with follow-up from qualified research personnel concerning pump settings, side effects, and incremental dose increase. While continuing to use the medication, there are 4 weeks of closed-loop pump therapy and drug use; glycemic outcomes will be taken from the last 4 weeks. This will be followed by laboratory and anthropometric testing, followed by 2 weeks of wash-out.

Study groups in NCT05205928
Study groupRoleWhat they receive
Placebo + closed-loop insulin systemActive comparatorNot described
Receives: Drug: Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy
Semaglutide, Ozempic® (at maximum tolerated dose) + closed-loop insulin systemExperimentalSemaglutide 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.
Receives: Drug: Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 4 weeks

Secondary outcomes (15)

  1. Percentage of time spent in the following ranges of glucose levels between 3.9 and 7.8 mmol/L

    % as per CGM data

    Measured: 4 weeks

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

    % as per CGM data

    Measured: 4 weeks

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

    % as per CGM data

    Measured: 4 weeks

  4. Mean glucose level

    Defined as per CGM data, in mmol/L

    Measured: 4 weeks

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

    Defined as per CGM data, in mmol/L

    Measured: 4 weeks

  6. Percentage coefficient of variation of glucose levels

    % as per CGM data

    Measured: 4 weeks

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

    As per CGM data

    Measured: 4 weeks

  8. Glycated hemoglobin

    Blood test to assess control within last 3-4 months

    Measured: 15 weeks

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

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

    Measured: 15 weeks

  10. Blood pressure and heart rate

    Body measurements as described (mmHg and beats per minutes)

    Measured: 15 weeks

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

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

    Measured: 15 weeks

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

    Blood tests, in mmol/L

    Measured: 15 weeks

  13. Biochemical analyses (exploratory)

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

    Measured: 15 weeks

  14. Urine albumin-creatinine ratio

    Urine test

    Measured: 15 weeks

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

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

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2022
  2. Study start2 Oct 2022
  3. Primary completion15 Apr 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05205928
Sponsor's protocol ID
2022-8097
Acronym
SEMA-AP
Status last verified
Jan 2025
First submitted
13 Dec 2021
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Protocol will be included upon finalization onto the website, as well as upon request.

Publications

  • Pasqua MR, Tsoukas MA, Kobayati A, Aboznadah W, Jafar A, Haidar A. Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial. Nat Med. 2025 Apr;31(4):1239-1245. doi: 10.1038/s41591-024-03463-z. Epub 2025 Jan 10.

    PubMed 39794615

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy in people with Type 1 Diabetes and Diabetes Mellitus, Type 1, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time of plasma glucose levels spent in target range (semaglutide vs placebo) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05205928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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SEMA-AP Clinical Trial NCT05205928 | AzTrials