Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy
Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy
Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin
 resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are
 at high risk of many serious diabetic complications, including cardiovascular disease,
 blindness, nerve damage and kidney damage. Balaglitazone is a thiazolidinedione derivative
 that is being developed as an oral anti-diabetic drug to improve blood glucose control in
 patients with type 2 diabetes. The purpose of this study is to assess if additional treatment
 with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve
 blood glucose control and decrease the daily insulin dose compared to placebo, but with less
 impact on weight gain and oedema than pioglitazone (Actos®) 45 mg.
Inclusion Criteria:

 1. Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO criteria for at
 least 3 months

 2. Age ≥ 18 years

 3. BMI ≥ 25.0 kg/m2

 4. HbA1c ≥ 7.0 %

 5. Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least
 75 days

 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