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A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04032197
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study looks into how the type 2 diabetes medicine, semaglutide, can prevent risk of heart disease complications and stroke. Participants will either get semaglutide or placebo ("dummy" medicine) - which treatment is decided by chance. Semaglutide is a new medicine to treat type 2 diabetes and can be prescribed by doctors in some countries. The study medicine will be in a pen, and must be injected with a needle in the stomach, thigh or upper arm once a week. The study will last for 57-63 weeks. Participants will have 10 clinic visits with the study doctor, 5 visits to the specialised clinic for imaging and at least 1 phone contact. Participants' health will be monitored carefully and blood samples will therefore be taken at the clinic visits. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Placebo (semaglutide) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
Official Title: A Trial Investigating the Effect of Semaglutide on Atherosclerosis in Patients With Cardiovascular Disease and Type 2 Diabetes
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : May 6, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide
Semaglutide injected once-weekly. Standard dose escalations every 4 weeks will be applied, until the maximum dose of 1.0 mg semaglutide is reached.
Drug: Semaglutide
Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).

Placebo Comparator: Placebo
Placebo injected once-weekly. Standard dose escalations every 4 weeks will be applied, until the maximum dose of 1.0 mg placebo is reached.
Drug: Placebo (semaglutide)
Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).




Primary Outcome Measures :
  1. Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries [ Time Frame: From baseline (from 41 days before randomisation) to week 26 ]
    Ratio


Secondary Outcome Measures :
  1. Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries [ Time Frame: From baseline (from 40 days before randomisation) to week 26 ]
    Ratio

  2. Change in myocardial perfusion reserve (MPR) [ Time Frame: From baseline (from 40 days before randomisation) to week 26 ]
    Ratio

  3. Change in total wall volume of the most diseased carotid artery [ Time Frame: From baseline (from 41 days before randomisation) to week 52 ]
    mm3



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age above or equal to 50 years at the time of signing informed consent
  • Body mass index equal to or less than 39.9 kg/m^2
  • Diagnosed with type 2 diabetes 180 daysor more prior to the day of the first screening visit
  • HbA1c 6.5 %−8.5 % (48−69 mmol/mol) (both inclusive)
  • Established cardiovascular disease

Exclusion Criteria:

  • Hospitalisation for unstable angina pectoris or transient ischaemic attack within 90 days prior to the day of the first screening visit.
  • Planned coronary, carotid or peripheral artery revascularisation.
  • Presently classified as being in New York Heart Association (NYHA) equal to or above Class III.
  • Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or systemic anti-inflammatory drugs within 90 days prior to the first screening visit. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032197


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Austria
Novo Nordisk Investigational Site Recruiting
Graz, Austria, 8010
Denmark
Novo Nordisk Investigational Site Not yet recruiting
Gentofte, Denmark, 2820
Sweden
Novo Nordisk Investigational Site Recruiting
Uppsala, Sweden, 75237
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04032197     History of Changes
Other Study ID Numbers: NN9535-4430
U1111-1215-4058 ( Other Identifier: World Health Organization (WHO) )
2018-002289-38 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases