Condition or disease | Intervention/treatment | Phase |
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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 |
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Active Comparator: Semaglutide
Semaglutide 2mg/1.5 ml (1.34 mg/ml) Prefilled pen for SQ injection
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Drug: Semaglutide 2 MG/1.5 ML Subcutaneous Solution
Semaglutide 2 MG/1.5 ML Subcutaneous Solution
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Placebo Comparator: Placebo
Placebo 1.5 ml, pen-injector for SC injection.
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Drug: Placebo
Placebo 1.5 ml, pen-injector for SC injection.
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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 | |||||||
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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
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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
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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
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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 |