Last updated: February 28, 2022
Sponsor: Laboratorios Silanes S.A. de C.V.
Overall Status: Active - Recruiting
Phase
3
Condition
Diabetes Mellitus, Type 2
Treatment
N/AClinical Study ID
NCT04882293
SIL-30301-III-20(1)
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- That the subject agrees to participate in the study and gives their informed consentin 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 whileconducting the study.
Exclusion
Exclusion Criteria:
- The drug is contraindicated for medical reasons.
- Consumption of oral contraceptives, cyclosporine or strong cytochrome p450 (CYP) 3A4inhibitors, 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 ofnormal, or GGT ≥3 times the upper limit of normal.
- Chronic or acute pancreatitis except for acute pancreatitis due to severehypertriglyceridemia (defined by the presence of triglycerides> 1000 mg / dl and / ormilky plasma, in the absence of other etiological factors of pancreatitis).
- Patients with active gallbladder disease (defined as acute or chronic gallbladderdisorders 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 theinvestigational drug.
- The patient is participating in another clinical study involving an investigationaltreatment or participated in one in the previous 4 weeks.
- At the medical discretion, a disease that affects the prognosis and preventsoutpatient management, for example, but not restricted to: end-stage cancer, kidney,heart, respiratory or liver or mental failure or with scheduled surgical or hospitalprocedures.
- Be a patient with a working relationship with the principal investigator or theresearch center or prisoner.
Study Design
Total Participants: 78
Study Start date:
February 15, 2022
Estimated Completion Date:
May 31, 2022
Study Description
Connect with a study center
Laboratorio Silanes, S.A. de C.V.
Mexico City, 11000
MexicoActive - Recruiting
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