Type 1 DiabetesPhase 2/3SEMA SMANCT06387199
Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide
A Phase 2/3 study testing Semaglutide with 4 meal strategies in people with Type 1 Diabetes and Diabetes Mellitus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes, Diabetes Mellitus
- What is being tested?
- Semaglutide with 4 meal strategies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2024to Jan 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 18 years of age
- 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)
- Minimum 3-month use of a commercial advanced automated insulin delivery system. 4.4. Agreement to use an effective method of birth control for individuals with child-bearing potential. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a 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
- Use of GLP1-RAs within the last 4 weeks.
- Use of any anti-hyperglycemic agent other than insulin within the last 2 weeks.
- Planned or ongoing pregnancy
- Breastfeeding
- 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 15Show 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 <30 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
- Bariatric surgery within the last 6 months.
- A serious medical or psychiatric illness that is likely to interfere with study participation as per the judgment of the investigator (e.g. cirrhosis, active cancer, decompensated schizophrenia).
- Body mass index ≤ 21 kg/m2
- 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)
- Concern for safety of the participant, as per the clinical judgment of the primary investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
Gabrielle Kemp, DEC Nursing, (438) 886-2171, gabrielle.kemp@rimuhc.ca
Michael Tsoukas, MD
About this study
Official title: Alleviating Carbohydrate Counting Using Weekly Subcutaneous Semaglutide Injections in People with Type 1 Diabetes on Closed-Loop Insulin Therapy: a 2x4 Factorial Randomized Placebo-Controlled Trial
A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Primarily designed for managing type 1 diabetes, this system has demonstrated significant benefits in previous studies. Yet, despite these advantages, certain challenges persist.
Semaglutide, utilized in treating type 2 diabetes and obesity, is a once-weekly injectable medication that elevates levels of a gastrointestinal hormone known as Glucagon-Like Peptide-1 (GLP-1). This hormone alters gastric emptying, inhibits glucagon release, and reduces appetite. While not officially sanctioned for type 1 diabetes treatment in North America, studies have explored its efficacy as an adjunctive therapy alongside insulin, yielding favorable outcomes in blood glucose regulation. Comparable drugs like liraglutide and exenatide have been employed in type 1 diabetes treatment as well, albeit with less pronounced glucose-regulating effects compared to semaglutide, even in type 2 diabetes.
The goal of this 50-week randomized placebo-controlled crossover 2x4 factorial designed trial is to assess whether commercial automated insulin delivery (AID) systems using rapid-acting insulin with adjunct weekly injections of semaglutide (at the maximally tolerated dose) can replace carbohydrate counting with simple meal announcements (SMA) without degrading glucose control.
Read the detailed description
The main questions this study aims to answer are:
- Can weekly injections of semaglutide at the maximum tolerated dose in individuals with T1D on closed-loop therapy with SMA and rapid-acting insulin result in a non-inferior time spent in target range (3.9-10 mmol/L) compared to weekly placebo injections on closed-loop system with full carbohydrate counting.
- Can weekly injections of semaglutide at the maximum tolerated dose, in combination with ultra-rapid actin insulin (Lyumjev);
- Eliminate carbohydrate counting and any meal announcement (i.e fully closed-loop) in people with T1D on closed-loop therapy without degrading glucose control.
- Be more effective in substituting carbohydrate counting with SMA in people with T1D on closed-loop therapy compared with traditional rapid-acting insulin.
Participants will be asked to undergo two subsequent blinded drug interventions; one with semaglutide and the other with placebo. Both interventions include 4 meal strategies each with a 3-week duration; full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev.
- Conditions
- Type 1 Diabetes, Diabetes Mellitus
- Being tested
- Semaglutide with 4 meal strategies, Placebo with 4 meal strategies
- Keywords
- insulin, Closed-loop system, GLP-1 receptor agonist, Semaglutide, Diabetes mellitus, type 1, ozempic
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide with 4 meal strategiesDrug
The blinded drug will be used in addition to the participants routine closed-loop insulin pump therapy. It will be administered through subcutaneous injection on a weekly basis. The first 12 weeks will include progressively increasing doses of the drug whereby, the dose increases every 4 weeks. Once the maximum tolerated dose is achieved after 12 weeks, participants will undergo 4 meal strategies in a randomized order. These include (in no particular order); full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev. Each meal strategy will be 3 weeks in duration and will occur sequentially in the designated order.
Placebo with 4 meal strategiesDrug
The blinded drug will be used in addition to the participants routine closed-loop insulin pump therapy. It will be administered through subcutaneous injection on a weekly basis. The first 12 weeks will include progressively increasing doses of the drug whereby, the dose increases every 4 weeks. Once the maximum tolerated dose is achieved after 12 weeks, participants will undergo 4 meal strategies in a randomized order. These include (in no particular order); full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev. Each meal strategy will be 3 weeks in duration and will occur sequentially in the designated order.
| Study group | Role | What they receive |
|---|---|---|
| Weekly placebo injections on regular closed-loop insulin pump therapy | Active comparator | Not described Receives: Drug: Placebo with 4 meal strategies |
| Weekly semaglutide (Ozempic®) injections on regular closed-loop insulin pump therapy | Experimental | Semaglutide is a Glucagon-like peptide 1 (GLP-1) receptor agonist. It up regulates GLP-1, which reduces glucagon levels, increases satiety and - in some particular cases - increases insulin production. It will be subcutaneously injected weekly by participants at progressively increasing doses. Once the maximum tolerated dose is achieved, participants will begin the meal strategies. Receives: Drug: Semaglutide with 4 meal strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of daytime 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 plasma glucose for placebo vs semaglutide (at maximal tolerated dose) on closed-loop insulin therapy
Measured: 24 weeks
Secondary outcomes (20)
Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L
% as per CGM data
Measured: 24 weeks
Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L
% as per CGM data
Measured: 24 weeks
Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L
% as per CGM data
Measured: 24 weeks
Mean glucose level
Defined as per CGM data, in mmol/L
Measured: 24 weeks
Standard deviation of glucose levels as a measure of glucose variability
Defined as per CGM data, in mmol/L
Measured: 24 weeks
Percentage coefficient of variation of glucose levels
% as per CGM data
Measured: 24 weeks
Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70%
As per CGM data
Measured: 24 weeks
Glycated hemoglobin (HbA1c)
Blood test to assess glucose control within 3-4 months
Measured: 24 weeks
Area under the curve 0-2h post meal, 0-3h post peal
As per CGM data
Measured: 24 weeks
Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire
17-item questionnaire with a 6-point Likert scale from 1 (no stress) to 6 (high stress) for each item. Total score obtained from summing the scores of all items
Measured: 24 weeks
Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire
8-item questionnaire with a 7-point Likert scale ranging from 0 (low satisfaction) to 6 (high satisfaction). Total score obtained from summing the scores of all items.
Measured: 24 weeks
Average scores between interventions based on the Hypoglycemic Fear Survey - II
33-item questionnaire with a 5-point Likert scale ranging from 1 (never) to 5 (almost always). Total score obtained from summing the scores of all items.
Measured: 24 weeks
Heart rate
Beats per minute
Measured: 24 weeks
Blood pressure
mmHg
Measured: 24 weeks
Measure of body weight
Measurements done at visit - weight in kilograms
Measured: 24 weeks
Measure of body mass index
Measurements done at visit - body mass index as per kg/m^2
Measured: 24 weeks
Measure of waist circumference and hip circumference
Measurements done at visit - circumference in cm
Measured: 24 weeks
Measure of waist-to-hip ratio
Measurements done at visit
Measured: 24 weeks
Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides
Blood tests, in mmol/L
Measured: 24 weeks
Urine albumin-creatinine ratio
Urine test
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Dec 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- randomized placebo-controlled crossover 2x3 factorial designed trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Tsoukas, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387199
- Sponsor's protocol ID
- 2024-10227
- Acronym
- SEMA SMA
- Status last verified
- Dec 2024
- First submitted
- 18 Apr 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data (that is, insulin delivery, glucose levels and individual participant data) and informed consent form will be shared by the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the McGill University Health Center's Research Ethics Board. All data shared will be de-identified. Raw data will be shared for non-commercial use upon reasonable request and a material transfer agreement.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Carbohydrate Counting Using Weekly Subcutaneous Semaglutide Injections in People with Type 1 Diabetes on Closed-Loop Insulin Therapy: a 2x4 Factorial Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06387199
- Acronym / sponsor ID
- SEMA SMA / 2024-10227
- Conditions
- Type 1 Diabetes, Diabetes Mellitus
- Keywords
- insulin, Closed-loop system, GLP-1 receptor agonist, Semaglutide, Diabetes mellitus, type 1, ozempic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Primarily designed for managing type 1 diabetes, this system has demonstrated significant benefits in previous studies. Yet, despite these advantages, certain challenges persist.
Semaglutide, utilized in treating type 2 diabetes and obesity, is a once-weekly injectable medication that elevates levels of a gastrointestinal hormone known as Glucagon-Like Peptide-1 (GLP-1). This hormone alters gastric emptying, inhibits glucagon release, and reduces appetite. While not officially sanctioned for type 1 diabetes treatment in North America, studies have explored its efficacy as an adjunctive therapy alongside insulin, yielding favorable outcomes in blood glucose regulation. Comparable drugs like liraglutide and exenatide have been employed in type 1 diabetes treatment as well, albeit with less pronounced glucose-regulating effects compared to semaglutide, even in type 2 diabetes.
The goal of this 50-week randomized placebo-controlled crossover 2x4 factorial designed trial is to assess whether commercial automated insulin delivery (AID) systems using rapid-acting insulin with adjunct weekly injections of semaglutide (at the maximally tolerated dose) can replace carbohydrate counting with simple meal announcements (SMA) without degrading glucose control.
Detailed description
The main questions this study aims to answer are:
- Can weekly injections of semaglutide at the maximum tolerated dose in individuals with T1D on closed-loop therapy with SMA and rapid-acting insulin result in a non-inferior time spent in target range (3.9-10 mmol/L) compared to weekly placebo injections on closed-loop system with full carbohydrate counting.
- Can weekly injections of semaglutide at the maximum tolerated dose, in combination with ultra-rapid actin insulin (Lyumjev);
- Eliminate carbohydrate counting and any meal announcement (i.e fully closed-loop) in people with T1D on closed-loop therapy without degrading glucose control.
- Be more effective in substituting carbohydrate counting with SMA in people with T1D on closed-loop therapy compared with traditional rapid-acting insulin.
Participants will be asked to undergo two subsequent blinded drug interventions; one with semaglutide and the other with placebo. Both interventions include 4 meal strategies each with a 3-week duration; full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized placebo-controlled crossover 2x3 factorial designed trial
| Arm | Type | Receives |
|---|---|---|
| Weekly placebo injections on regular closed-loop insulin pump therapy | Active comparator | Drug: Placebo with 4 meal strategies |
| Weekly semaglutide (Ozempic®) injections on regular closed-loop insulin pump therapy | Experimental | Drug: Semaglutide with 4 meal strategiesSemaglutide is a Glucagon-like peptide 1 (GLP-1) receptor agonist. It up regulates GLP-1, which reduces glucagon levels, increases satiety and - in some particular cases - increases insulin production. It will be subcutaneously injected weekly by participants at progressively increasing doses. Once the maximum tolerated dose is achieved, participants will begin the meal strategies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- 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)
- Minimum 3-month use of a commercial advanced automated insulin delivery system. 4.4. Agreement to use an effective method of birth control for individuals with child-bearing potential. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.
Key exclusion criteria (15 listed)
- Use of GLP1-RAs within the last 4 weeks.
- Use of any anti-hyperglycemic agent other than insulin within the last 2 weeks.
- Planned or ongoing pregnancy
- Breastfeeding
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide with 4 meal strategiesThe blinded drug will be used in addition to the participants routine closed-loop insulin pump therapy. It will be administered through subcutaneous injection on a weekly basis. The first 12 weeks will include progressively increasing doses of the drug whereby, the dose increases every 4 weeks. Once the maximum tolerated dose is achieved after 12 weeks, participants will undergo 4 meal strategies in a randomized order. These include (in no particular order); full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev. Each meal strategy will be 3 weeks in duration and will occur sequentially in the designated order. | Drug | Weekly semaglutide (Ozempic®) injections on regular closed-loop insulin pump therapy |
| Placebo with 4 meal strategiesThe blinded drug will be used in addition to the participants routine closed-loop insulin pump therapy. It will be administered through subcutaneous injection on a weekly basis. The first 12 weeks will include progressively increasing doses of the drug whereby, the dose increases every 4 weeks. Once the maximum tolerated dose is achieved after 12 weeks, participants will undergo 4 meal strategies in a randomized order. These include (in no particular order); full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev. Each meal strategy will be 3 weeks in duration and will occur sequentially in the designated order. | Drug | Weekly placebo injections on regular closed-loop insulin pump therapy |
Primary outcome
Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo)
Time frame: 24 weeks
Target range is defined to be between 3.9 and 10.0 mmol/L of plasma glucose for placebo vs semaglutide (at maximal tolerated dose) on closed-loop insulin therapy
20 secondary outcomes
Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L
Time frame: 24 weeks
Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L
Time frame: 24 weeks
Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L
Time frame: 24 weeks
Mean glucose level
Time frame: 24 weeks
Standard deviation of glucose levels as a measure of glucose variability
Time frame: 24 weeks
Percentage coefficient of variation of glucose levels
Time frame: 24 weeks
Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70%
Time frame: 24 weeks
Glycated hemoglobin (HbA1c)
Time frame: 24 weeks
Area under the curve 0-2h post meal, 0-3h post peal
Time frame: 24 weeks
Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire
Time frame: 24 weeks
Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire
Time frame: 24 weeks
Average scores between interventions based on the Hypoglycemic Fear Survey - II
Time frame: 24 weeks
Heart rate
Time frame: 24 weeks
Blood pressure
Time frame: 24 weeks
Measure of body weight
Time frame: 24 weeks
Measure of body mass index
Time frame: 24 weeks
Measure of waist circumference and hip circumference
Time frame: 24 weeks
Measure of waist-to-hip ratio
Time frame: 24 weeks
Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides
Time frame: 24 weeks
Urine albumin-creatinine ratio
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. The raw data (that is, insulin delivery, glucose levels and individual participant data) and informed consent form will be shared by the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the McGill University Health Center's Research Ethics Board. All data shared will be de-identified. Raw data will be shared for non-commercial use upon reasonable request and a material transfer agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Semaglutide with 4 meal strategies in people with Type 1 Diabetes and Diabetes Mellitus, 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 3 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabrielle Kemp, Registered Nurse ((438) 886-2171, gabrielle.kemp@rimuhc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.