Type 2 DiabetesPhase 4STOPNCT03985384
Semaglutide Treatment On Coronary Progression
A Phase 4 study testing Semaglutide 2 MG/1.5 ML Subcutaneous Solution in people with Type 2 Diabetes and Coronary Artery Disease, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to see the effect of the diabetes medicine Semaglutide on a condition called atherosclerosis. Atherosclerosis is a narrowing, blockage, or hardening of the arteries due to a build up of calcium. This study will look specifically at the arteries involving the heart. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes, Coronary Artery Disease
- What is being tested?
- Semaglutide 2 MG/1.5 ML Subcutaneous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 27 Dec 2022
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women with type 2 diabetes with a glycated hemoglobin level of 7.0% or more, drug naïve, or treated with oral agents and/or basal insulin. For patients on basal insulin at entry, the PI will consider dose reduction of basal insulin according to A1c and risk for hypoglycemia. Patients on SGLT-2 inhibitors may be screened but the agents must be discontinued at least 30 days prior to randomization.
- Age > 40 years of age at the time of the initial Screening visit (V1) with a diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines and with at least one cardiovascular risk factor (hypertension, high cholesterol, family history of premature heart disease or past/current smoking) or prior ASCVD (prior stroke, TIA, claudication, coronary artery disease)
- Willingness to participate in the study and ability to sign informed consent
- In the investigator's opinion subjects are willing and likely able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures whether or not they receive investigational product for the duration of the trial.
Who cannot join
- History of type 1 diabetes mellitus or a history of ketoacidosis.
- Current use of GLP-1-receptor agonists or use of a GLP-1 receptor agonist within 3 mos. of screening.
- Current Use of SGLT-2 inhibitors within 30 days of screening
- Subjects on prandial insulin or using an insulin pump or pramlintide.
- Any clinically significant malabsorption condition.
- History of one or more severe hypoglycemic episodes within 6 months of Screening (V1) or a severe hypoglycemic episode occurring during the interval between the Screening visit (V1) and randomization.
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- Subjects experiencing a cardiovascular event (e.g., myocardial infarction or stroke) or undergoing coronary angioplasty or peripheral intervention procedure between the Screening visit (V1) and randomization.
- Recent ASCVD Event (stroke, heart attack, ACS or revascularization) within 3 months (90 days) of the screening visit (VI).
- Subjects undergoing any cardiovascular surgery (e.g., valvular surgery) within 3 months (90 days) of the Screening visit (V1).
- Subjects with any planned coronary revascularization or peripheral intervention procedure or other cardiovascular surgery.
- Subjects with New York Heart Association (NYHA) Class III or IV heart failure at the Screening visit (V1).
- Renal insufficiency (calculated creatinine clearance of <50 ml per minute, MDRD equation).
- AST or ALT >2 X the upper limit of normal (ULN) at the Screening visit (V1), or a total bilirubin >1.5 X the ULN unless the subject has a history of Gilbert's.
- Weight in excess of 325 pounds
- Resting hypotension (systolic blood pressure of <90mmHg) or resting hypertension (systolic blood pressure of >170mmHg or diastolic blood pressure of >110 mmHg) or the treating physician is allowed to adjust background blood pressure medication(s) to lower blood pressure values in order for the subject to be re-assessed for enrollment eligibility.
- Subject has a history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Note (1) A subject with a history of malignancy >5 years prior to signing informed consent should have no evidence of residual or recurrent disease.
- Note (2) a subject with any history of melanoma, leukemia, lymphoma, or renal cell carcinoma is excluded.
- At randomization, subject has developed a new medical condition, suffered a change in status of an established medical condition, developed a laboratory or ECG abnormality, or required a new treatment or medication during the pre-randomization period which meets any previously described trial exclusion criterion or which, in the opinion of the investigator, exposes the subject to risk by enrolling in the trial.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality at the Screening visit (V1) that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
- Subjects with known allergy to iodinated contrast material
- Subject is pregnant or breast-feeding, or is expecting to conceive during the trial, including 35 days following the last dose of blinded investigational product.
- Females of childbearing potential must use adequate contraceptive methods.
- Participation in other studies involving investigational drug (s) (Phases 1-4) within 30 days before the Screening visit (V1) and/or during trial participation.
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- Personal history of non-familial medullary thyroid carcinoma.
- Known or suspected hypersensitivity to trial products.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Effect of Semaglutide on Coronary Atherosclerosis Plaque Progression in Type 2 Diabetics
The purpose of this research study is to see the effect of the diabetes medicine Semaglutide on a condition called atherosclerosis. Atherosclerosis is a narrowing, blockage, or hardening of the arteries due to a build up of calcium. This study will look specifically at the arteries involving the heart.
Read the detailed description
To determine the effects of semaglutide therapy on the morphology and composition of non-calcified coronary atherosclerotic plaque (NCP), including the progression of plaque volume.
- Conditions
- Type 2 Diabetes, Coronary Artery Disease
- Being tested
- Semaglutide 2 MG/1.5 ML Subcutaneous Solution, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2 MG/1.5 ML Subcutaneous SolutionDrug
Semaglutide 2 MG/1.5 ML Subcutaneous Solution
PlaceboDrug
Placebo 1.5 ml, pen-injector for SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Active comparator | Semaglutide 2mg/1.5 ml (1.34 mg/ml) Prefilled pen for SQ injection Receives: Drug: Semaglutide 2 MG/1.5 ML Subcutaneous Solution |
| Placebo | Placebo comparator | Placebo 1.5 ml, pen-injector for SC injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in non-calcified plaque volume
Rate of change in non-calcified plaque volume
Measured: 12 months
Secondary outcomes (1)
Rate of change in total plaque volume
Rate of change in total plaque volume
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start30 Apr 2019
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind Placebo Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Matthew Budoff, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985384
- Sponsor's protocol ID
- 22174-01
- Acronym
- STOP
- Status last verified
- Oct 2023
- First submitted
- 10 Jun 2019
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Semaglutide on Coronary Atherosclerosis Plaque Progression in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT03985384
- Acronym / sponsor ID
- STOP / 22174-01
- Conditions
- Type 2 Diabetes, Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 13 Jun 2019 (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.
The purpose of this research study is to see the effect of the diabetes medicine Semaglutide on a condition called atherosclerosis. Atherosclerosis is a narrowing, blockage, or hardening of the arteries due to a build up of calcium. This study will look specifically at the arteries involving the heart.
Detailed description
To determine the effects of semaglutide therapy on the morphology and composition of non-calcified coronary atherosclerotic plaque (NCP), including the progression of plaque volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blind Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Active comparator | Drug: Semaglutide 2 MG/1.5 ML Subcutaneous SolutionSemaglutide 2mg/1.5 ml (1.34 mg/ml) Prefilled pen for SQ injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1.5 ml, pen-injector for SC injection. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women with type 2 diabetes with a glycated hemoglobin level of 7.0% or more, drug naïve, or treated with oral agents and/or basal insulin. For patients on basal insulin at entry, the PI will consider dose reduction of basal insulin according to A1c and risk for hypoglycemia. Patients on SGLT-2 inhibitors may be screened but the agents must be discontinued at least 30 days prior to randomization.
- Age > 40 years of age at the time of the initial Screening visit (V1) with a diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines and with at least one cardiovascular risk factor (hypertension, high cholesterol, family history of premature heart disease or past/current smoking) or prior ASCVD (prior stroke, TIA, claudication, coronary artery disease)
- Willingness to participate in the study and ability to sign informed consent
- In the investigator's opinion subjects are willing and likely able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures whether or not they receive investigational product for the duration of the trial.
Key exclusion criteria (27 listed)
- History of type 1 diabetes mellitus or a history of ketoacidosis.
- Current use of GLP-1-receptor agonists or use of a GLP-1 receptor agonist within 3 mos. of screening.
- Current Use of SGLT-2 inhibitors within 30 days of screening
- Subjects on prandial insulin or using an insulin pump or pramlintide.
- Any clinically significant malabsorption condition.
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 2 MG/1.5 ML Subcutaneous SolutionSemaglutide 2 MG/1.5 ML Subcutaneous Solution | Drug | Semaglutide |
| PlaceboPlacebo 1.5 ml, pen-injector for SC injection. | Drug | Placebo |
Primary outcome
Rate of change in non-calcified plaque volume
Time frame: 12 months
Rate of change in non-calcified plaque volume
1 secondary outcome
Rate of change in total plaque volume
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
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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. This study is not recruiting at the moment.
Matthew Budoff, MD principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide 2 MG/1.5 ML Subcutaneous Solution in people with Type 2 Diabetes and Coronary Artery Disease, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
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 27 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 5 Oct 2023. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Rate of change in non-calcified plaque volume (time frame: 12 months). 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 5 Oct 2023.