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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-12

Study Completion Date

2023-06-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures

Study Groups

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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.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

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

Placebo injected once-weekly. Standard dose escalations every 4 weeks will be applied, until the maximum dose of 1.0 mg placebo is reached.

Group Type PLACEBO_COMPARATOR

Placebo (semaglutide)

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type 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).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No