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

Inclusion criteria

• Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO criteria for at least 3 months
• Age ≥ 18 years
• BMI ≥ 25.0 kg/m2
• HbA1c ≥ 7.0 %
• Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least 75 days

Exclusion criteria

• Prior or current use of any PPAR-γ agonist
• Recent use (< 3 months) of an investigational drug
• Pre-existing medical condition judged to preclude safe participation in the study
• Contraindication/intolerance to study medication
• Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
• Diagnosed or receiving medication for heart failure, NYHA I to IV
• Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention
• Uncontrolled treated/untreated systolic blood pressure >180 mmHg and/or diastolic blood pressure > 95 mmHg
• Known diabetic macular oedema
• Hematuria
• Serum creatinine >130 μmol/l
• ALT, AST, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal
• 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
• Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives)
• Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation
• Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocols
• 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