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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Dnipropetrovsk State Medical Academy
Sponsor:
Information provided by (Responsible Party):
Koval' O., MD, Dnipropetrovsk State Medical Academy
ClinicalTrials.gov Identifier:
NCT02015988
First received: December 14, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Diabetes Mellitus, Type 2
Hypertriglyceridemia
Drug: Fenofibrate
Drug: Simvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dnipropetrovsk State Medical Academy:

Primary Outcome Measures:
  • Percentage change from baseline in triglycerides (TG) at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in apoB/apoA1 ratio at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in uric acid at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in apoB/apoA1 ratio at week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
  • Percentage changes from baseline in uric acid at week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of adverse events (AE) caused discontinuations of investigational products [ Time Frame: Up to 52 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015988

Contacts
Contact: Olena A Koval', MD, PhD +380676320919 koval_olena@ukr.net
Contact: Sergiy V Romanenko, MD, PhD +380509631998 s.v.romanenko@yandex.ru

Locations
Ukraine
State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine" Recruiting
Dnipropetrovsk, Ukraine
Contact: Sergiy V Romanenko, MD, PhD    +380509631998    s.v.romanenko@yandex.ru   
Principal Investigator: Olena A Koval', MD, PhD         
Sub-Investigator: Sergiy V Romanenko, MD, PhD         
Sub-Investigator: Pavlo O Kaplan, MD, PhD         
Sponsors and Collaborators
Koval' O., MD
Investigators
Principal Investigator: Olena A Koval', MD, PhD State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"
  More Information

No publications provided

Responsible Party: Koval' O., MD, PhD, Professor, Dnipropetrovsk State Medical Academy
ClinicalTrials.gov Identifier: NCT02015988     History of Changes
Other Study ID Numbers: A14-284
Study First Received: December 14, 2013
Last Updated: March 11, 2014
Health Authority: Ukraine: Ministry of Health

Keywords provided by Dnipropetrovsk State Medical Academy:
Acute coronary syndrome
Diabetes Mellitus, Type 2
Hypertriglyceridemia
Simvastatin
Fenofibrate

Additional relevant MeSH terms:
Hypertriglyceridemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Acute Coronary Syndrome
Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Disease
Pathologic Processes
Simvastatin
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014