In patients with type 2 diabetes the evaluation of Pioglitazone versus glibenclamide or metformin on markers of inflammation, platelets activation, thrombogenesis and oxidative stress

Takeda Italia Farmaceutici S.p.A.0 个研究点目标入组 100 人开始时间: 2008年10月21日最近更新: 2020年1月13日

试验速览

暂无简介。

•diagnosis of type 2 diabetes mellitus
•age >=35 and <=75 years
•subjects of either sex
•HbA1c levels <=9.0%
•treatment only by diet from at least 3 months
•female patients had to be postmenopausal, hysterectomised or surgically sterilized or using reliable and adequate contraceptive methods (oral contraception or Intra-uterine Devices [IUD])
•female (childbearing potential) patients had to show a negative response to pregnancy test
•a co-operative attitude and ability to be trained to use correctly the investigational study drugs and to attain the study procedures
•written informed consent provided

•Type 1 diabetes mellitus;
•Treatment with other oral antidiabetics drugs or insulin in the 3 months preceding study entry;
•Pregnant or lactating females;
•Any disease with malabsorption;
•Acute or chronic pancreatitis;
•Familiar polyposis coli;
•Past medical history of myocardial infarction, transient ischemic attacks (TIAs) or stroke;
•Congestive heart failure (New York Heart Association [NYHA] I-IV class);
•Significant liver (Alanine aminoytransferase [ALT] > 2.5 upper limit of normal range) or renal (serum creatinine > 1.2 mg/dL) impairment;
•Anaemia of any aetiology (defined as haemoglobin levels < 10.5 g/dL) or any other clinically relevant haematological disease;
•Diagnosis or suspicion of any neoplastic disease;
•History of chronic alcohol or drug/substance abuse, or presence of other conditions potentially able to affect study subjects’ compliance;
•Concomitant therapy with statins, antioxidant drugs (e.g. vitamins, Q10 coenzyme, Superoxide dismutase [SOD]), beta-blockers, non steroidal antinflammatory drugs (NSAIDS), aspirin, corticosteroids;
•Known allergy, sensitivity or intolerance to study drugs and/or study drugs formulation ingredients;
•Participation in another trial in the 3 months preceding study entry

发起方

Takeda Italia Farmaceutici S.p.A.