Type 2 Diabetes mellitus
Conditions
Interventions
Product Name: Actos 45 mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone hydrochloride
Current Sponsor code: AD-4833
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 Diabetes mellitus 2. Angiographically proven CHD (diagnosed within the last 6 months) 3. hs CRP > 1 mg/l 4. Age 20-80 years 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
Exclusion criteria: 1. Chronic inflammatory diseases (rheumatic diseases, pyelonephritis, osteomyelitis or others.) 2. Acute infections 3. Treatment or pre-treatment with insulin for more than 6 consecutive days 4. Invasive cardiovascular intervention within the last 4 weeks 5. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures 6. History of severe or multiple allergies 7. Treatment with any other investigational drug within 3 months before trial entry. 8. Progressive fatal disease 9. Drug or alcohol abuse within the last 5 years 10. A history of symptomatic cardiac insufficiency (NYHA stage II - IV), respiratory, or hepatic insufficiency 11. Relevant anaemia (as judged by investigator) 12. Blood donation within the last 30 days or intended blood donation (during the study or 30 days after participation?) 13. Pregnancy or breast feeding 14. Sexually active woman of childbearing age not practicing birth control by using contraceptive medication, condoms or intrauterine devices (IUD). 15. Lack of compliance or other similar reason, that, the investigator believes, precludes satisfactory participation in the study 16. Pre-treatment with thiazolidinediones 17. Systemic glucocorticoid therapy 18. Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypoglycaemia) within 6 month prior to entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of PPARy-activation by pioglitazone treatment on several markers of inflammation and cardiovascular risk in patients with type 2 diabetes and angiographically proven coronary heart disease. Primary efficacy variable is the change of MMP-9 on day 28 vs. day 0;Secondary Objective: The following secondary efficacy variables will be analysed: - IL 6; hs CRP, plasma glucose, HbA1c (d0 and d28), insulin, proinsulin intact, adiponectin, MCP-1, sCD 40L - insulin sensitivity - blood lipids (total cholesterol, LDL, HDL, triglycerides) - beta cell function according to HOMA-B - sICAM 1, sVICAM 1, P-Selectin, t-PA - body weight, body mass index - HOMA S - Angiotensin II - complement factors - Standardized blood pressure measurement ;Primary end point(s): Change of MMP-9 on day 28 vs. day 0 | — |
Countries
Germany
Outcome results
None listed