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

Arm | Intervention/treatment |
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Experimental: Simvastatin and Fenofibrate
Simvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year)
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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)
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Drug: Simvastatin
Other Name: Zocor-forte |
- Percentage change from baseline in triglycerides (TG) at week 12 [ Time Frame: Baseline, Week 12 ]
- 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 ]
- Percentage changes from baseline in apoB/apoA1 ratio at week 12 [ Time Frame: Baseline, Week 12 ]
- Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12 [ Time Frame: Baseline, Week 12 ]
- Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12 [ Time Frame: Baseline, Week 12 ]
- Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12 [ Time Frame: Baseline, Week 12 ]
- Percentage changes from baseline in uric acid at week 12 [ Time Frame: Baseline, Week 12 ]
- 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 ]
- Percentage changes from baseline in apoB/apoA1 ratio at week 52 [ Time Frame: Baseline, Week 52 ]
- Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52 [ Time Frame: Baseline, Week 52 ]
- Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52 [ Time Frame: Baseline, Week 52 ]
- Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52 [ Time Frame: Baseline, Week 52 ]
- Percentage changes from baseline in uric acid at week 52 [ Time Frame: Baseline, Week 52 ]
- Number of adverse events (AE) caused discontinuations of investigational products [ Time Frame: Up to 52 week ]

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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 |
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

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
Ukraine | |
State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine" | |
Dnipropetrovsk, Ukraine |
Principal Investigator: | Olena A Koval', MD, PhD | State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine" |
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 |
Acute coronary syndrome Diabetes Mellitus, Type 2 Hypertriglyceridemia Simvastatin Fenofibrate |
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 |