NCT01103648 is a NA clinical trial of Simvastatin in Prediabetes, sponsored by Federal University of São Paulo.

Who is sponsoring NCT01103648?

NCT01103648 is sponsored by Federal University of São Paulo.

What drugs are being tested in NCT01103648?

Interventions in NCT01103648: Simvastatin, Ezetimibe, Combination Simvastatin plus Ezetimibe.

What condition does NCT01103648 study?

NCT01103648 studies Prediabetes, Hypercholesterolemia, Inflammation, Cardiovascular Risk.

Is NCT01103648 still recruiting?

NCT01103648 is currently completed. Last updated 14 April 2010.

Last reviewed 2010-04-14 · How we verify

NCT01103648

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

Synergistic Effect of Simvastatin and Ezetimibe on Lipid and Pro-inflammatory Profiles in Pre-diabetic Subjects

Completed NA Last updated 14 April 2010

What this trial tests

NA trial testing Simvastatin in Prediabetes in 50 participants. Completed in 1 November 2007.

Timeline

1 June 2005

Primary endpoint
1 May 2006

1 November 2007

Quick facts

Lead sponsor	Federal University of São Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 June 2005
Primary completion	1 May 2006
Estimated completion	1 November 2007
Sites	1 location across Brazil

Drugs / interventions tested

Simvastatin (simvastatin) — full drug profile →
Ezetimibe (EZETIMIBE) — full drug profile →
Combination Simvastatin plus Ezetimibe — full drug profile →

Conditions studied

Prediabetes — all drugs for Prediabetes →
Hypercholesterolemia — all drugs for Hypercholesterolemia →
Inflammation — all drugs for Inflammation →
Cardiovascular Risk — all drugs for Cardiovascular Risk →

Sponsor

Federal University of São Paulo

Who can join

Adults 18 to 75, any sex, with Prediabetes or Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

C reactive protein
Time frame: Serum C reactive protein was detected at baseline, before starting monotherapy with simvastatin or ezetimibe, and after 12 weeks of each monotherapy
CRP is one of the most important inflammatory marker and its determination has been considered a non-traditional risk factor for several chronic diseases including diabetes and cardiovascular diseases.
C reactive protein
Time frame: C reactive protein (CRP) concentration was determined after 12 weeks of monotherapy (simvastatin or ezetimibe) and was compared with the concentration after more 12 weeks of combined therapy
CRP is one of the most important inflammatory marker and its determination has been considered a non-traditional risk factor for several chronic diseases including diabetes and cardiovascular diseases.
C reactive protein
Time frame: Serum C reactive protein (CRP) concentration detected at baseline was compared with that obtained after of combined therapy of simvastatin plus ezetimibe (week 24)
CRP is one of the most important inflammatory marker and its determination has been considered a non-traditional risk factor for several chronic diseases including diabetes and cardiovascular diseases.

Sponsor's own description

Ezetimibe specifically blocks the absorption of dietary and biliary cholesterol and plant sterols. Synergism of ezetimibe-statin therapy on LDL-cholesterol has been demonstrated, but data concerning the pleiotropic effects of this combination are controversial. We tested the hypothesis that the combination of simvastatin and ezetimibe would induce improvement in inflammatory status, as reflected by leukocyte count and CRP, IL-6 and TNF-a levels. This open-label trial evaluated whether this combination results in a synergistic effect the pro-inflammatory status of pre-diabetic subjects. Fifty pre-diabetic subjects were randomly assigned to one of 2 groups, one receiving ezetimibe (10 mg/d), the other, simvastatin (20 mg/d) for 12 weeks, followed by an additional 12-week period of combined therapy.

Publications & conference data

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

Synergistic effect of simvastatin and ezetimibe on lipid and pro-inflammatory profiles in pre-diabetic subjects.
Kater AL, Batista MC, Ferreira SR. · · 2010 · cited 16× · PMID 20529243 · DOI 10.1186/1758-5996-2-34
Molecular and Immunomodulatory Mechanisms of Statins in Inflammation and Cancer Therapeutics with Emphasis on the NF-κB, NLRP3 Inflammasome, and Cytokine Regulatory Axes.
Khan S, Huda B, Bhurka F, Patnaik R, et al · · 2025 · cited 7× · PMID 40943351 · DOI 10.3390/ijms26178429

Verify or expand the search:

Other trials of Simvastatin

Trials testing the same drug.

NCT07102979 — Remedial Mechanism of Simvastatin and Ursodeoxycholic Acid in Liver Cirrhosis: Crosstalk of Bile Secretion, Gut Microbio · NA · enrolling by invitation
NCT06948747 — A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of E · Phase 1 · completed
NCT06858332 — Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia · recruiting
NCT07031778 — Topic Simvastatin for Bone Regeneration · EARLY_PHASE1 · recruiting
NCT06399783 — Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata · Phase 4 · not yet recruiting

Other recruiting trials for Prediabetes

Currently open trials in the same condition.

NCT07529366 — Pharmacist-Led Continuous Glucose Monitoring for Prediabetes · recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
NCT07478263 — Behavioral Approach for Latinas Addressing Nutrition, Cravings, and Eating Patterns to Prevent Type 2 Diabetes · NA · recruiting
NCT07491653 — Fiber mHealth Intervention for Prediabetes · NA · recruiting
NCT07372729 — Smartwatch-based Intervention for Cardiovascular Health (SWITCH) · NA · recruiting

Other Federal University of São Paulo trials

Trials by the same sponsor.

NCT07376811 — Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome · NA · not yet recruiting
NCT06805656 — Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals · Phase 2 · not yet recruiting
NCT06970964 — Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota Helps Triathletes With Cold-Like Symptoms Before a · NA · completed
NCT06905860 — Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis · Phase 4 · not yet recruiting
NCT06829992 — Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players · 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 NCT01103648 (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 Federal University of São Paulo
Last refreshed: 14 April 2010

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/NCT01103648.

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