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

Diabetes Mellitus, Type 2 Clinical Trial

— BALLET  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515632
• Other study ID #: DRF2593-307
• Secondary ID: EudraCT No. 2007
• Status: Completed
• Phase: Phase 3
• First received: August 13, 2007
• Last updated: July 22, 2010
• Start date: July 2007
• Est. completion date: October 2009

Study information

• Verified date: July 2010
• Source: Rheoscience A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: October 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Balaglitazone
One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.

Locations

Country	Name	City	State
Denmark	Multi-center	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rheoscience A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters.		baseline, 4, 8, 12, 17, 21 and 26 weeks	No
Secondary	Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin		baseline and 26 weeks	Yes