EUCTR2007-006706-14-AT
Active, not recruiting
Not Applicable
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 sites200 target enrollmentApril 14, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Takeda Pharma GmbH
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diabetes mellitus type 2
- •2\. HbA1c \>\= 6\.5% \<\= 8\.5%
- •3\. Treatment with Insulin Glargine with or without OAD Therapy since 3 months
- •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
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
Outcomes
Primary Outcomes
Not specified
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