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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02015988
• Other study ID #: A14-284
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 14, 2013
• Last updated: August 3, 2016
• Start date: January 2014
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: Dnipropetrovsk State Medical Academy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertriglyceridemia
• Syndrome

Intervention

Drug:
• Fenofibrate

• Simvastatin

Locations

Country	Name	City	State
Ukraine	State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"	Dnipropetrovsk

Sponsors (1)

Lead Sponsor	Collaborator
Koval' O., MD

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adverse events (AE) caused discontinuations of investigational products		Up to 52 week	Yes
Primary	Percentage change from baseline in triglycerides (TG) at week 12		Baseline, Week 12	No
Secondary	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	No
Secondary	Percentage changes from baseline in apoB/apoA1 ratio at week 12		Baseline, Week 12	No
Secondary	Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12		Baseline, Week 12	No
Secondary	Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12		Baseline, Week 12	No
Secondary	Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12		Baseline, Week 12	No
Secondary	Percentage changes from baseline in uric acid at week 12		Baseline, Week 12	No
Secondary	Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 52		Week 52	No
Secondary	Percentage changes from baseline in apoB/apoA1 ratio at week 52		Baseline, Week 52	No
Secondary	Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52		Baseline, Week 52	No
Secondary	Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52		Baseline, Week 52	No
Secondary	Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52		Baseline, Week 52	No
Secondary	Percentage changes from baseline in uric acid at week 52		Baseline, Week 52	No