Aditive effects of omega-3 polyunsaturated fatty acids and pioglitazone in the treatment of type 2 diabetes mellitus - MEPIO

• Conditions: The project deals with hummoral and metabolic aspects of insulin resistance (IR), which is assumed to be the basic metabolic disorder which leads to the development of type 2 diabetes mellitus (T2D) and metabolic syndrome. Study population will be patients with T2D treated by metformin.

• Registration Number: EUCTR2009-011106-42-CZ
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by WHO, Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (American Diabetes Association, 2004) at least 3 months preceding screening

2. Concurrent T2DM therapy:
Taking metformin as a monotherapy at stable dose in at least 2 months preceding week 0 procedures
Previous chronic diabetes therapy will be limited to: sulfonylureas, glitinides, biguanides, ? glucosidase inhibitors such as acarbose, insulin.

3. HbA1c (IFCC): < 8 % (equals to aprox. 10% by DCCT), Triglycerides 2-6 mmol/l

4. Men and women who are 30 to 70 years of age

5. Body Mass Index between 25 and 45 (kg/m2)

6. Informed Consent: a signed and dated written consent obtained from the subject before any procedures are performed

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Metabolic Disease including:
Diagnosis of Type 1 diabetes mellitus
Uncorrected thyroid dysfunction. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 3 months prior to Screening, and who have a screening thyroid stimulating hormone (TSH) within the limits of normal may participate).
2.Significant weight gain or loss (as defined as > 5% of total body weight) within the past 3 months prior to Screening.
3.Regular use of insulin in previous 3 months
4.History of clinically significant cardiovascular disease including:
Documented myocardial infarction in the past year
Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in the previous year and no subsequent angina
Unstable angina
Congestive heart failure (CHF) classified as New York Heart Association (NYHA) Class II, III or IV heart failure
5.Blood pressure > 150/100mmHg or HR > 100 beats/minute. Subjects using antihypertensives must be on stable doses during the 3 months prior to Screening and during the trial.
6.If a subject is receiving lipid-lowering therapy, then they must have been on the same dose of therapy for the past 3 months, concomitant fenofibrate therapy is not allowed and must be withdrawn at least 1 month ahead of week 0 procedures.
7.Is currently lactating, pregnant or actively trying to become pregnant.
8.Has a significant renal impairment as defined by serum creatinine > 150umol/L.
9.Has a documented history of chronic or advanced hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen, hepatitis B core antigen, and hepatitis C antibody) at Screening.
Has clinically significant hepatic enzyme elevation greater than 2.5 times the upper limit of the reference range value /alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) /
Has a total bilirubin level that is > 1.5 times the ULRR at Screening.
10.Has a history of alcohol or substance abuse within the past year
11.Is currently taking and will not stop prohibited concomitant medications, see concomitant therapy.
12.Known allergy to any of the capsule excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation.
13.Received treatment with an investigational drug or participated in any other clinical trial during the previous 3 months.
14.Clinically significant anemia (i.e., hemoglobin < 120.0g/L for males and < 110.0g/L for females) or any other abnormal hematological profile that is considered by the investigator to be clinically significant.
15.In the opinion of the Investigator has a risk of non-compliance with study procedures, or cannot read, understand, or complete study-related materials, particularly the informed consent.
16.Has any concurrent condition or any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram, including pulmonary, neurological or inflammatory diseases, which, in the opinion of the Investigator, may affect the interpretation of efficacy and safety data, or which otherwise, contraindicates participation in a clinical trial with the chemical entity.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified