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AzTrials

Dyslipidemia Associated With Type II Diabetes MellitusPhase 3NCT04882293

Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.

A Phase 3 study testing Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose and Atorvastatin (Lipitor ®) in people with Dyslipidemia Associated With Type II Diabetes Mellitus, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose and Atorvastatin (Lipitor ®)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteMexico
Study dates
15 Feb 2022to May 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Jorge A González, PhD contact

5254883785 ext. 3761

jogonzalez@silanes.com.mx

Yulia G Romero-Antonio, B.S. contact

5554883700 ext. 3777

yromero@silanes.com.mx

Mexico1 site, 1 recruiting

  • Laboratorio Silanes, S.A. de C.V.

    Mexico City, 11000

    Jorge A Gonzalez, PhD, +5254883785 ext. 3761, jogonzalez@silanes.com.mx

    Yulia Romero-Antonio, B.S., 5554883700 ext. 3777, yromero@silanes.com.mx

    Recruiting

Other trials in Mexico

About this study

Official title: Confirmatory Study of the Efficacy and Safety of the Fixed-dose Combination Atorvastatin / Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients With Type 2 Diabetes (T2D) and Dyslipidaemia (DLP).

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.

Read the detailed description

To assess 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. Assessing the magnitude of change in lipid profile numbers. And describing the effect on anthropometric, biochemical and clinical indicators, as well as events and adverse reactions that may occur. In patients diagnosed with type 2 diabetes and dyslipidemia (triglycerides> 150 mg / dl, LDL (Low density lipoprotein) cholesterol> 100 mg / dl) and who require pharmacological treatment for lipid control.

Being tested
Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose, Atorvastatin (Lipitor ®)
Keywords
Dyslipidemia, Type 2 diabetes, Hypertriglyceridemia, Lipid profile
Medical subject headings
Dyslipidemias, Diabetes Mellitus, Type 2, Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin 20 mg / Fenofibrate 160 mg in fixed doseDrug

    Also called ATV / FENO

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

  • Atorvastatin (Lipitor ®)Drug

    Also called ATV (Lipitor ®)

    1 tablet once a day, 20 mg, Orally

Study groups in NCT04882293
Study groupRoleWhat they receive
Group A: Atorvastatin / Fenofibrate in fixed doseExperimentalGroup A: Atorvastatin / Fenofibrate in fixed dose Pharmaceutical Form: Tablets Dosage: 20 mg /160 mg Adminstration way: Oral
Receives: Drug: Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose
Group B: Atorvastatin (Lipitor ®)Active comparatorGroup B: Atorvastatin (Lipitor ®) Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral
Receives: Drug: Atorvastatin (Lipitor ®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 2 and 4 months.

  2. 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.

    Measured: 4 months

  3. 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.

    Measured: Baseline and 4 months.

Secondary outcomes (11)

  1. Impact on anthropometric indicators (Weight)

    Describe changes in weight (kg) measurements from baseline to the end of the study (4 months).

    Measured: Baseline and 4 Months

  2. Impact on anthropometric indicators body mass index (BMI)

    Describe changes in BMI (kg/m2) from baseline to the end of the study (4 months)

    Measured: Baseline and 4 months

  3. Impact on anthropometric indicators (Waist circumference)

    Describe changes in waist circumference (cm) from baseline to the end of the study (4 months).

    Measured: Baseline and 4 months

  4. Impact on liver function with aspartate aminotransferas (AST)

    Describe the changes in AST (mg/dL) concentration, between baseline and the end of the study.

    Measured: Baseline and 4 months

  5. Impact on liver function with Alanine Aminotransferase (ALT)

    Describe the changes in ALT (mg/dL) concentration, between baseline and the end of the study.

    Measured: Baseline and 4 months

  6. Impact on Glycosylated hemoglobin (HbA1c)

    Describe the changes in HbA1c percentage from baseline to the end of the study (4 months).

    Measured: Baseline and 4 months

  7. Impact on glucose levels

    Describe the changes in glucose levels (mg/dL) from baseline to the end of the study (4 months).

    Measured: Baseline and 4 months

  8. Impact on Blood pressure

    Describe the changes in blood pressure (mm Hg) from baseline to the end of the study (4 months). impact on clinical indicators (Blood pressure, Heart rate, Respiratory rate).

    Measured: Baseline and 4 months

  9. Impact on heart rate

    Describe the changes in heart rate (beats per minute) from baseline to the end of the study (4 months).

    Measured: Baseline and 4 months

  10. Impact on respiratory rate

    Describe the changes in respiratory rate (Pulses per minute) from baseline to the end of the study (4 months).

    Measured: Baseline and 4 months

  11. Events and adverse reactions presented.

    Proportion of events and adverse reactions presented during 4 months of treatment.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start15 Feb 2022
  3. Primary completionMay 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04882293
Sponsor's protocol ID
SIL-30301-III-20(1)
Status last verified
Feb 2022
First submitted
29 Apr 2021
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24603993

  • 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.

    PubMed 24516261

  • 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.

    PubMed 24083205

  • 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.

    PubMed 12087019

  • 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.

    PubMed 40323331

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose and Atorvastatin (Lipitor ®) in people with Dyslipidemia Associated With Type II Diabetes Mellitus, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jorge A González, PhD (5254883785 ext. 3761, jogonzalez@silanes.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Magnitude of change in lipid profile figures. (time frame: Baseline, 2 and 4 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04882293, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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