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 sites100 target enrollmentOctober 21, 2008

Overview

No summary available.

Registry

who.int

Start Date

October 21, 2008

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Takeda Italia Farmaceutici S.p.A.

•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;