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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04032197
• Collaborator: (none)
• Enrollment: 100
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 42.6
• Patients Per Site: 25
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 12, 2019
• Anticipated Primary Completion Date: Jan 24, 2022
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries [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 [From baseline (from 40 days before randomisation) to week 26]

   Ratio

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

   mm3

3. Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery [From baseline (from 41 days before randomisation) to week 52]

   mm3

4. Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery [From baseline (from 41 days before randomisation) to week 52]

   mm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 6.0% - 9.0% (42-75 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Graz		Austria	8010
2	Novo Nordisk Investigational Site	Gentofte		Denmark	2820
3	Novo Nordisk Investigational Site	Stockholm		Sweden	171 76
4	Novo Nordisk Investigational Site	Uppsala		Sweden	75237

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04032197
• Other Study ID Numbers: NN9535-4430; U1111-1215-4058; 2018-002289-38
• First Posted: Jul 25, 2019
• Last Update Posted: Jun 18, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 18, 2021