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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00515632
• Date of registration: 13/08/2007
• Primary sponsor: Rheoscience A/S
• Public title: Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy BALLET
• Scientific title: A Randomized, Double-blind, Parallel-group, Placebo and Active Comparator (Pioglitazone)-Controlled Clinical Study to Determine the Efficacy and Safety of Balaglitazone in Patients With Type 2 Diabetes on Stable Insulin Therapy
• Date of first enrolment: July 2007
• Target sample size: 409
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00515632
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Denmark

Contacts

• Name: Bente J Riis, MD
• Affiliation: Nordic Bioscience Clinical Studies A/S

Key inclusion & exclusion criteria

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-? 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Balaglitazone

Primary Outcome(s)

HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters. [Time Frame: baseline, 4, 8, 12, 17, 21 and 26 weeks]

Secondary Outcome(s)

Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin [Time Frame: baseline and 26 weeks]

Secondary ID(s)

DRF2593-307

EudraCT No. 2007-002088-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors