Impact of Pioglitazone, Metformin and the combination of both on cardiovascular risk in insulin-treated patients with Type 2 diabetes – The PIOcomb Study - PIOcomb Study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Diabetes mellitus type 2
2. HbA1c >= 6.5% <= 8.5%
3. Treatment with the following insulins with or without OAD Therapy since 3 months:
a. Long acting basal insulin analogs,
b. NPH insulin,
c. Combination insulin with 1-2 daily doses; except intensified insulin therapies
4. Age 30 – 75 years
5. BMI >= 25
6. Written informed consent

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. History of type 1 diabetes mellitus
2. Uncontrolled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >95mmHg), change of antihypertensive treatment within the last 2 weeks
3. Acute infections
4. NSAIDs (incl. low dose ASA) or Cox-2-inhibitors if therapy initiated within the last 4 weeks
5. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure
6. History of severe or multiple allergies
7. Treatment with any other investigational drug within 4 weeks before trial entry
8. History of drug or alcohol abuse in the past 5 years
9. A history of significant cardiovascular (NYHA stage I - IV; determined by anamnesis and clinical status), respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, GFR < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or haematological disease as judged by the investigator
10. History of macular oedema
11. State after kidney transplantation
12. Serum potassium > 5.5 mmol/L
13. History of primary hyperaldosteronism
14. Pregnancy or breast feeding
15. Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner
16. Treatment with thiazolidinediones within the past 3 months
17. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous year
18. Any elective surgery during study participation
19. If statin therapy applicable: Change of medication within the last 4 weeks
20. Pre-treatment with gemfibrozil within the last 12 weeks
21. Pre-treatment with rifampicin within the last 12 weeks
22. Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypoglycaemia) within 6 months prior to screening visit
23. History of dehydration, precoma diabeticum or shock or diabetic ketoacidosis within the past year prior to screening visit
24. Acute or scheduled investigation with iodine containing radiopaque material
25. Uncontrolled unstable angina pectoris
26. Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm
27. Postmenopausal woman with present osteoporosis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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