NCT04882293

Brief Summary

Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

April 29, 2021

Last Update Submit

February 28, 2022

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus

Keywords

DyslipidemiaType 2 diabetesHypertriglyceridemiaLipid profile

Outcome Measures

Primary Outcomes (3)

  • Magnitude of change in lipid profile figures.

    To assess the magnitude of change in lipid profile figures (Lp \[a\], LDL, and triglycerides) at 2 and 4 months with respect to their baseline measurement and between treatment groups.

    Baseline, 2 and 4 months.

  • Proportion of subjects achieving triglyceride levels <150 mg /dL.

    Describe the proportion of subjects who achieved triglyceride levels \<150 mg / dL at the end of treatment.

    4 months

  • Describe the proportion of subjects who reduced levels of LDL cholesterol

    Describe the proportion of subjects who reduced levels of LDL cholesterol, under 30% compare to the baseline value.

    Baseline and 4 months.

Secondary Outcomes (11)

  • Impact on anthropometric indicators (Weight)

    Baseline and 4 Months

  • Impact on anthropometric indicators body mass index (BMI)

    Baseline and 4 months

  • Impact on anthropometric indicators (Waist circumference)

    Baseline and 4 months

  • Impact on liver function with aspartate aminotransferas (AST)

    Baseline and 4 months

  • Impact on liver function with Alanine Aminotransferase (ALT)

    Baseline and 4 months

  • +6 more secondary outcomes

Study Arms (2)

Group A: Atorvastatin / Fenofibrate in fixed dose

EXPERIMENTAL

Group A: Atorvastatin / Fenofibrate in fixed dose Pharmaceutical Form: Tablets Dosage: 20 mg /160 mg Adminstration way: Oral

Drug: Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose

Group B: Atorvastatin (Lipitor ®)

ACTIVE COMPARATOR

Group B: Atorvastatin (Lipitor ®) Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral

Drug: Atorvastatin (Lipitor ®)

Interventions

Atorvastatin 20 mg / Fenofibrate 160 mg in fixed doseDRUG

1 tablet once a day, 20 mg /160 mg, Orally

Also known as: ATV / FENO
Group A: Atorvastatin / Fenofibrate in fixed dose
Atorvastatin (Lipitor ®)DRUG

1 tablet once a day, 20 mg, Orally

Also known as: ATV (Lipitor ®)
Group B: Atorvastatin (Lipitor ®)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • That the subject agrees to participate in the study and gives their informed consent in writing.
  • Both genres.
  • Age 18 to 75 years old.
  • Diagnosis of type 2 diabetes mellitus with adequate glycemic control defined by HbA1c ≤ 7.5% at the time of selection.
  • Diagnosis of dyslipidemia prior to the start of the study (LDL cholesterol\> 100 mg / dl and triglycerides\> 150 mg / dl).
  • Willing to avoid sexual contact or to use a barrier method of contraception while conducting the study.

You may not qualify if:

  • The drug is contraindicated for medical reasons.
  • Consumption of oral contraceptives, cyclosporine or strong cytochrome p450 (CYP) 3A4 inhibitors, protease inhibitors, erythromycin and azoles.
  • Patients with Type 1 Diabetes Mellitus.
  • Acute or Severe renal dysfunction (glomerular filtration \<30 ml / min / 1.72 m2).
  • History of chronic liver disease or ALT and / or AST ≥ 2 times the upper limit of normal, or GGT ≥3 times the upper limit of normal.
  • Chronic or acute pancreatitis except for acute pancreatitis due to severe hypertriglyceridemia (defined by the presence of triglycerides\> 1000 mg / dl and / or milky plasma, in the absence of other etiological factors of pancreatitis).
  • Patients with active gallbladder disease (defined as acute or chronic gallbladder disorders associated with clinical signs or symptoms).
  • Patient with a history or presence of myopathies.
  • Pregnant or lactating women.
  • Known contraindication or hypersensitivity to the use of any of the components of the investigational drug.
  • The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
  • At the medical discretion, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver or mental failure or with scheduled surgical or hospital procedures.
  • Be a patient with a working relationship with the principal investigator or the research center or prisoner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

RECRUITING

Related Publications (5)

  • Escobedo-de la Pena J, de Jesus-Perez R, Schargrodsky H, Champagne B. [Prevalence of dyslipidemias in Mexico city and Its relation to other cardiovascular risk factors. Results from the CARMELA study]. Gac Med Mex. 2014 Mar-Apr;150(2):128-36. Spanish.

    PMID: 24603993BACKGROUND

  • Harivenkatesh N, David DC, Haribalaji N, Sudhakar MK. Efficacy and safety of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia: a randomized controlled trial. J Cardiovasc Pharmacol Ther. 2014 May;19(3):296-303. doi: 10.1177/1074248413518968. Epub 2014 Feb 10.

    PMID: 24516261BACKGROUND

  • Lella M, Indira K. A comparative study of efficacy of atorvastatin alone and its combination with fenofibrate on lipid profile in type 2 diabetes mellitus patients with hyperlipidemia. J Adv Pharm Technol Res. 2013 Jul;4(3):166-70. doi: 10.4103/2231-4040.116778.

    PMID: 24083205BACKGROUND

  • Athyros VG, Papageorgiou AA, Athyrou VV, Demitriadis DS, Kontopoulos AG. Atorvastatin and micronized fenofibrate alone and in combination in type 2 diabetes with combined hyperlipidemia. Diabetes Care. 2002 Jul;25(7):1198-202. doi: 10.2337/diacare.25.7.1198.

    PMID: 12087019BACKGROUND

  • Padilla-Padilla FG, Ruiz-Bernes LN, Roman-Pintos LM, Peraza-Zaldivar JA, Sander-Padilla JG, Lugo-Sanchez LA, Rios-Brito KF, Arguedas-Nunez MM, Flores-Huanosta D, Gonzalez-Canudas J. Efficacy and Safety of the Fixed-Dose Combination of Atorvastatin/Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients with Type 2 Diabetes and Dyslipidemia. Cardiol Ther. 2025 Jun;14(2):297-314. doi: 10.1007/s40119-025-00410-y. Epub 2025 May 5.

    PMID: 40323331DERIVED

Related Links

MeSH Terms

Conditions

DyslipidemiasDiabetes Mellitus, Type 2Hypertriglyceridemia

Interventions

AtorvastatinFenofibrate

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System DiseasesHyperlipidemias

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsFibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • Alberto J Zamora Muciño-Arroyo, M.D

    Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)

    PRINCIPAL INVESTIGATOR

  • Joel Rodríguez Saldaña, M.D

    Resultados médicos, desarrollo e investigación SC (REMEDI)

    PRINCIPAL INVESTIGATOR

  • Francisco G Padilla Padilla, M.D

    Independent

    PRINCIPAL INVESTIGATOR

  • Juan A Peraza Zaldivar, M.D

    Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)

    PRINCIPAL INVESTIGATOR

  • Luis M Román Pintos, PhD

    Hospital Hispano S.A de C.V

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge A González, PhD

CONTACT

5254883785jogonzalez@silanes.com.mx

Yulia G Romero-Antonio, B.S.

CONTACT

5554883700yromero@silanes.com.mx

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 11, 2021

Study Start

February 15, 2022

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)