Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy

Exclusion Criteria

• •1. Prior or current use of any PPAR-γ agonist
• •2. Recent use (\< 3 months) of an investigational drug
• •3. Pre-existing medical condition judged to preclude safe participation in the study
• •4. Contraindication/intolerance to study medication
• •5. Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
• •6. Diagnosed or receiving medication for heart failure, NYHA I to IV
• •7. Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention
• •8. Uncontrolled treated/untreated systolic blood pressure \>180 mmHg and/or diastolic blood pressure \> 95 mmHg
• •9. Known diabetic macular oedema
• •10. Hematuria
• •11. Serum creatinine \>130 μmol/l
• •12. ALT, AST, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal
• •13. Haemoglobin significantly (in the Investigators opinion, but not more than 1 mmol/L) below the lower limit of normal or haemoglobinopathy interfering with valid HbA1c assay
• •14. Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives)
• •15. Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation
• •16. Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocols
• •17. Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial