Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome

NCT02015988 | Unknown Phase 4

• 1 other identifier: A14-284
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To test the hypothesis that early (within 5-21 days after index event) administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG with diabetes.

Conditions

Acute Coronary Syndrome; Diabetes Mellitus, Type 2; Hypertriglyceridemia

Keywords

Acute coronary syndrome; Diabetes Mellitus, Type 2; Hypertriglyceridemia; Simvastatin; Fenofibrate

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline in triglycerides (TG) at week 12

  Baseline, Week 12

Secondary Outcomes (12)

• Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 12

  Week 12

• Percentage changes from baseline in apoB/apoA1 ratio at week 12

  Baseline, Week 12

• Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12

  Baseline, Week 12

• Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12

  Baseline, Week 12

• Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12

  Baseline, Week 12

Other Outcomes (1)

• Number of adverse events (AE) caused discontinuations of investigational products

  Up to 52 week

Study Arms (2)

Simvastatin and Fenofibrate

EXPERIMENTAL

Simvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year)

Drug: Fenofibrate; Drug: Simvastatin

Simvastatin

ACTIVE COMPARATOR

Simvastatin 40 mg once daily orally for 52 weeks (1 year)

Drug: Simvastatin

Interventions

Fenofibrate DRUG

Also known as: Tricor

Simvastatin and Fenofibrate

Simvastatin DRUG

Also known as: Zocor-forte

Simvastatin; Simvastatin and Fenofibrate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus
• Fasting triglycerides ≥ 1,7 mmol/l
• In case of previous statin therapy, last LDL-C measurement before event should be ≤ 2,6 mmol/l
• Written informed consent obtained

You may not qualify if:

• Heart failure IV class (NYHA)
• Acute decompensated heart failure
• Life expectancy no more than 1 year
• Chronic kidney disease (CKD) with Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
• Severe chronic liver diseases with Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \> 3 Upper Limit of Normal (ULN)
• Known gallbladder disease, including cholecystolithiasis
• Creatinphosphokinase (CPK) \> 5 ULN at baseline
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen,
• Known allergy to peanut or arachis oil or soya lecithin or related products
• Hypersensitivity to simvastatin or fenofibrate or to any of the excipients of the investigational drugs
• Concomitant administration of potent cytochrome P450 isoenzyme 3A4 inhibitors (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone)
• Pregnancy and lactation

Sponsors & Collaborators

• Koval' O., MD: lead

Study Sites (1)

State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"

Dnipropetrovsk, Ukraine

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Diabetes Mellitus, Type 2; Hypertriglyceridemia

Interventions

Fenofibrate; Simvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Olena A Koval', MD, PhD

  State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: December 14, 2013
• First Posted: December 19, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: May 1, 2017
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

UA (1)