Who is sponsoring NCT03932721?

NCT03932721 is sponsored by University of Campinas, Brazil.

What drugs are being tested in NCT03932721?

Interventions in NCT03932721: Evolocumab 140 MG/ML.

What condition does NCT03932721 study?

NCT03932721 studies Dyslipidemia Associated With Type II Diabetes Mellitus, Diabetes Mellitus, Type 2, Hypertension Arterial.

Is NCT03932721 still recruiting?

NCT03932721 is currently completed. Last updated 9 March 2023.

Last reviewed 2023-03-09 · How we verify

NCT03932721: EXCEED-BHS3

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EXpanded Combination of Evolocumab Plus Empagliflozin on Diabetes: EXCEED-BHS3 Trial

Completed Phase 4 Last updated 9 March 2023

What this trial tests

Phase 4 trial testing Evolocumab 140 MG/ML in Dyslipidemia Associated With Type II Diabetes Mellitus in 110 participants. Completed in 30 October 2021.

Timeline

1 October 2018

Primary endpoint
30 June 2021

30 October 2021

Quick facts

Lead sponsor	University of Campinas, Brazil
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	110
Start date	1 October 2018
Primary completion	30 June 2021
Estimated completion	30 October 2021
Sites	1 location across Brazil

Drugs / interventions tested

Evolocumab 140 MG/ML — full drug profile →

Conditions studied

Dyslipidemia Associated With Type II Diabetes Mellitus — all drugs for Dyslipidemia Associated With Type II Diabetes Mellitus →
Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Hypertension Arterial — all drugs for Hypertension Arterial →

Sponsor

University of Campinas, Brazil

Who can join

Adults 40 to 70, any sex, with Dyslipidemia Associated With Type II Diabetes Mellitus or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Based on the current evidence, empagliflozin could reduce cardiovascular morbidity and mortality in Diabetes Mellitus Type 2 (T2DM). Anti-PCSK9 therapy (evolocumab) can reduce the major cardiovascular events incidence in secondary prevention individuals, some of them presenting T2DM. The beneficial effect of the combined use of these two agents in T2DM remains unknown. Evaluating the effect of evolocumab on top of the best of care therapy for T2DM, including empaglifozin, on endothelial function may indicate the existence of some benefit related to cardiovascular outcomes.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Evolocumab on top of empagliflozin improves endothelial function of individuals with diabetes: randomized active-controlled trial.
Sposito AC, Breder I, Barreto J, Breder J, et al · · 2022 · cited 16× · PMID 35933413 · DOI 10.1186/s12933-022-01584-8
Rationale and design of the expanded combination of evolocumab plus empagliflozin in diabetes: EXCEED-BHS3 trial.
Breder I, Cunha Breder J, Bonilha I, Munhoz DB, et al · · 2020 · cited 10× · PMID 33062236 · DOI 10.1177/2040622320959248
Effect of Empagliflozin with or without the Addition of Evolocumab on HDL Subspecies in Individuals with Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EXCEED-BHS3 Trial.
Bonilha I, Gomes ÉIL, Carmo HRP, Breder I, et al · · 2024 · cited 2× · PMID 38612917 · DOI 10.3390/ijms25074108

Verify or expand the search:

Other trials of Evolocumab 140 MG/ML

Trials testing the same drug.

NCT05661552 — Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI · Phase 4 · completed
NCT05585151 — High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study · Phase 4 · unknown
NCT04951856 — Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI · Phase 4 · active not recruiting

Other recruiting trials for Dyslipidemia Associated With Type II Diabetes Mellitus

Currently open trials in the same condition.

NCT07359105 — Moderate-intensity Statin vs. Individualized LDL-C Target-based Therapy in Older Adults With Type 2 Diabetes (iTARGET-El · NA · recruiting
NCT04943926 — Dietary Strategies for Remission of Type 2 Diabetes · NA · recruiting

Other University of Campinas, Brazil trials

Trials by the same sponsor.

NCT06929676 — Assessment of Tooth Mobility After Non-surgical Periodontal Treatment Followed by Tooth Splinting · NA · enrolling by invitation
NCT07456163 — Influence of Zirconia Abutments on Peri-Implant Tissues in Single-Tooth Restorations · NA · recruiting
NCT06884475 — Evaluation of Implantoplasty in the Treatment of Peri-Implantitis. · NA · active not recruiting
NCT06450327 — Resistant Hypertension An Open, Complicated ("Cum Plicare") or Complex ("Cum Plexus") Syndrome? · recruiting
NCT06600867 — Method for Measuring Dental Mobility and Displacement Force · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03932721 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Campinas, Brazil
Last refreshed: 9 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03932721.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing