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

NCT ID: NCT00515632

Last Updated: 2010-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-10-31

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Balaglitazone 10 mg per day

Group Type: EXPERIMENTAL

Balaglitazone

Intervention Type: DRUG

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

Balaglitazone 20 mg per day

Group Type: EXPERIMENTAL

Balaglitazone

Intervention Type: DRUG

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

Pioglitazone 45 mg per day

Group Type: ACTIVE_COMPARATOR

Balaglitazone

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Balaglitazone

Intervention Type: DRUG

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

Interventions

Balaglitazone

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

Intervention Type: DRUG

Eligibility 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-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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rheoscience A/S

OTHER

Sponsor Role: lead

Responsible Party

Rheoscience A/S

Principal Investigators

Bente J Riis, MD

Role: STUDY_DIRECTOR

Nordic Bioscience Clinical Studies A/S

Locations

Multi-center

Copenhagen, , Denmark

Countries

Denmark

References

Henriksen K, Byrjalsen I, Qvist P, Beck-Nielsen H, Hansen G, Riis BJ, Perrild H, Svendsen OL, Gram J, Karsdal MA, Christiansen C; BALLET Trial Investigators. Efficacy and safety of the PPARgamma partial agonist balaglitazone compared with pioglitazone and placebo: a phase III, randomized, parallel-group study in patients with type 2 diabetes on stable insulin therapy. Diabetes Metab Res Rev. 2011 May;27(4):392-401. doi: 10.1002/dmrr.1187.

Reference Type: DERIVED

PMID: 21328517 (View on PubMed)

Other Identifiers

EudraCT No. 2007-002088-29

Identifier Type: -

Identifier Source: secondary_id

DRF2593-307

Identifier Type: -

Identifier Source: org_study_id