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

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ClinicalTrials.gov Identifier: NCT02015988
Recruitment Status : Unknown
Verified August 2016 by Koval' O., MD, Dnipropetrovsk State Medical Academy.
Recruitment status was:  Active, not recruiting
First Posted : December 19, 2013
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Koval' O., MD, Dnipropetrovsk State Medical Academy

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Diabetes Mellitus, Type 2 Hypertriglyceridemia Drug: Fenofibrate Drug: Simvastatin Phase 4

Detailed Description:

The primary objective of this parallel group study is to demonstrate that the combined therapy of simvastatin and fenofibrate is superior compared to monotherapy with simvastatin based on the comparisons of change of TG levels after 12 weeks of treatment compared to baseline.

Secondary objectives are to compare both treatment alternatives the combination therapy of simvastatin and fenofibrate to simvastatin monotherapy with respect to achievement the European Society of Cardiology 2011 (ESC 2011) non-HDL-C target (less than 2,6 mmol/l), change of apolipoprotein B/apolipoprotein A1 (apoB/apoA1) ratio, High-Density Lipoprotein-Cholesterol (HDL-C), Low-Density Lipoprotein-Cholesterol (LDL-C) and Uric Acid (UA) after 12 weeks and 52 weeks (1 year) of treatment compared to baseline.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Tolerability of Early Initiation of Combined Lipid -Lowering Therapy Included Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus, Hypertriglyceridemia and Acute Coronary Syndrome
Study Start Date : January 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Simvastatin and Fenofibrate
Simvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year)
 Drug: Fenofibrate
Other Name: Tricor

Drug: Simvastatin
Other Name: Zocor-forte
Active Comparator: Simvastatin
Simvastatin 40 mg once daily orally for 52 weeks (1 year)
 Drug: Simvastatin
Other Name: Zocor-forte


Outcome Measures
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Primary Outcome Measures :
  1. Percentage change from baseline in triglycerides (TG) at week 12 [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures :
  1. Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 12 [ Time Frame: Week 12 ]
  2. Percentage changes from baseline in apoB/apoA1 ratio at week 12 [ Time Frame: Baseline, Week 12 ]
  3. Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12 [ Time Frame: Baseline, Week 12 ]
  4. Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12 [ Time Frame: Baseline, Week 12 ]
  5. Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12 [ Time Frame: Baseline, Week 12 ]
  6. Percentage changes from baseline in uric acid at week 12 [ Time Frame: Baseline, Week 12 ]
  7. Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 52 [ Time Frame: Week 52 ]
  8. Percentage changes from baseline in apoB/apoA1 ratio at week 52 [ Time Frame: Baseline, Week 52 ]
  9. Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52 [ Time Frame: Baseline, Week 52 ]
  10. Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52 [ Time Frame: Baseline, Week 52 ]
  11. Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52 [ Time Frame: Baseline, Week 52 ]
  12. Percentage changes from baseline in uric acid at week 52 [ Time Frame: Baseline, Week 52 ]

Other Outcome Measures:
  1. Number of adverse events (AE) caused discontinuations of investigational products [ Time Frame: Up to 52 week ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Fasting triglycerides ≥ 1,7 mmol/l
  • Acute coronary syndrome at least before 5 and maximum 21 days before the inclusion
  • If previously treated with statin therapy, the dose should be equivalent to 40 mg of simvastatin at inclusion
  • In case of previous statin therapy, last LDL-C measurement before event should be ≤ 2,6 mmol/l
  • Written informed consent obtained

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015988


Locations
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Ukraine
State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"
Dnipropetrovsk, Ukraine
Sponsors and Collaborators
Koval' O., MD
Investigators
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Principal Investigator: Olena A Koval', MD, PhD State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"
More Information
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Responsible Party: Koval' O., MD, PhD, Professor, Dnipropetrovsk State Medical Academy
ClinicalTrials.gov Identifier: NCT02015988    
Other Study ID Numbers: A14-284
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Keywords provided by Koval' O., MD, Dnipropetrovsk State Medical Academy:
Acute coronary syndrome
Diabetes Mellitus, Type 2
Hypertriglyceridemia
Simvastatin
Fenofibrate
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertriglyceridemia
Syndrome
Disease
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Simvastatin
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors