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Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist
Semaglutide + Closed-Loop Therapy for Type 1 Diabetes (SEMA-AP Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks
Awards & highlights
SEMA-AP Trial Summary
This trial is testing if semaglutide, a once-weekly injectable medication, can improve glucose control in those with type 1 diabetes when used with a closed-loop insulin system.
Who is the study for?
This trial is for individuals with type 1 diabetes who have been using an insulin pump for at least 3 months and have a glycated hemoglobin (HbA1c) level up to 11%. Participants should not be pregnant, breastfeeding, or planning pregnancy and must agree to use effective birth control. They shouldn't have a history of certain thyroid cancers, pancreatitis, gallbladder disease, severe hypoglycemia recently, or any serious medical condition that could affect participation.Check my eligibility
What is being tested?
The study tests if weekly injections of Semaglutide can improve blood sugar control in people with type 1 diabetes when used alongside a closed-loop insulin system (artificial pancreas). The trial compares the effects of Semaglutide against a placebo over an outpatient therapy period including usual treatment plus four weeks of closed-loop therapy.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or vomiting due to the effect on gastric emptying; low blood sugar levels; possible inflammation of organs such as the pancreas; and allergic reactions. As this drug affects appetite and digestion, changes in eating habits might also occur.
SEMA-AP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of time of plasma glucose levels spent in target range (semaglutide vs placebo)
Secondary outcome measures
Average scores between interventions based on quality of life questionnaires
Biochemical analyses (exploratory)
Blood pressure and heart rate
+12 moreSEMA-AP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Semaglutide, Ozempic® (at maximum tolerated dose) + closed-loop insulin systemExperimental Treatment1 Intervention
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.
Group II: Placebo + closed-loop insulin systemActive Control1 Intervention
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
442 Previous Clinical Trials
159,146 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Type 1 Diabetes for at least a year.You are currently breastfeeding.I have used a GLP1-receptor agonist in the last 2 weeks.I or my family have a history of medullary thyroid cancer or MEN2.I do not have severe eye or stomach issues related to diabetes.I have used diabetes medication other than insulin for less than 2 weeks.I had a severe low blood sugar episode that caused a seizure, unconsciousness, or an ER visit in the last 3 months.My kidney function is severely impaired, with an eGFR below 15.I agree to use effective birth control and avoid pregnancy during the trial.I have had pancreatitis or gallbladder disease before.You have had a bad reaction to GLP1-RAs before.I had weight loss surgery less than 6 months ago.I regularly take hydroxyurea and plan to use a Dexcom G6.Your body mass index is less than 21.I have been using an insulin pump for at least 3 months.I have had severe diabetic ketoacidosis requiring IV insulin in the last 6 months.Your glycated hemoglobin (HbA1c) level is up to 11% in a blood test taken within the last 6 months before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + closed-loop insulin system
- Group 2: Semaglutide, Ozempic® (at maximum tolerated dose) + closed-loop insulin system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT05205928 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are enrolled in this research project?
"Yes, this is an ongoing recruitment effort as indicated by the clinicaltrials.gov listing. This particular trial was posted on 8/2/2022 and updated as recently as 10/3/2022. They are looking for 28 participants at a single site."
Answered by AI
Can patients still join this particular research project?
"That is correct, the information available on clinicaltrials.gov reveals that this trial is still recruiting patients. This study was initially posted on August 2nd, 2020 and has been edited as recently as October 3rd, 2020. The researchers conducting this trial are looking for 28 individuals at a single location."
Answered by AI
Who else is applying?
What site did they apply to?
Research Institute of the McGill University Health Centre
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I am a type 1 diabetic and love to be a part of pushing the field, and treatment, forward.
PatientReceived 1 prior treatment
Hi, I want like to take part of this trial because the heavy condition of type 1 diabetes is what i live day and night from 7 years and to be part of a clinical trial on diabetes is very concerning for me, the everyday pain and frequent unbalances due to my very active life and addiction to sugar make me want to fight, learn more, understand more and help.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Research Institute of the McGill University Health Centre: < 48 hours
Average response time
- < 2 Days
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