| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Coronary Artery Disease | Drug: Semaglutide 2 MG/1.5 ML Subcutaneous Solution Drug: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Double Blind Placebo Controlled |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Semaglutide on Coronary Atherosclerosis Plaque Progression in Type 2 Diabetics |
| Actual Study Start Date : | April 30, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Semaglutide
Semaglutide 2mg/1.5 ml (1.34 mg/ml) Prefilled pen for SQ injection
|
Drug: Semaglutide 2 MG/1.5 ML Subcutaneous Solution
Semaglutide 2 MG/1.5 ML Subcutaneous Solution
|
|
Placebo Comparator: Placebo
Placebo 1.5 ml, pen-injector for SC injection.
|
Drug: Placebo
Placebo 1.5 ml, pen-injector for SC injection.
|
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
| Contact: Sajad Hamal, MS | 3109749334 ext 7217 | shamal@lundquist.org |
| United States, California | |
| Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center | Recruiting |
| Torrance, California, United States, 90502 | |
| Contact: Sajad Hamal, MS 310-974-9334 ext 7217 shamal@lundquist.org | |
| Principal Investigator: | Matthew Budoff, MD | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 10, 2019 | ||||||
| First Posted Date ICMJE | June 13, 2019 | ||||||
| Last Update Posted Date | January 28, 2021 | ||||||
| Actual Study Start Date ICMJE | April 30, 2019 | ||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Rate of change in non-calcified plaque volume [ Time Frame: 12 months ] Rate of change in non-calcified plaque volume
|
||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
Rate of change in total plaque volume [ Time Frame: 12 months ] Rate of change in total plaque volume
|
||||||
| Original Secondary Outcome Measures ICMJE |
To assess quantitative changes in total plaque in patients with type 2 diabetes who are on a standard of care regimen receiving once-weekly semaglutide or placebo with CTA [ Time Frame: 12 months ] Rate of change in total plaque volume with active and placebo compounds
|
||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Semaglutide Treatment On Coronary Progression | ||||||
| Official Title ICMJE | Effect of Semaglutide on Coronary Atherosclerosis Plaque Progression in Type 2 Diabetics | ||||||
| Brief 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. | ||||||
| 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 Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Double Blind Placebo Controlled Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
140 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | June 2022 | ||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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.
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03985384 | ||||||
| Other Study ID Numbers ICMJE | 22174-01 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||||
| Study Sponsor ICMJE | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||||
| Verification Date | January 2021 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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