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

Takeda Pharma GmbH0 sitesJanuary 24, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 24, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Takeda Pharma GmbH

•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

•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