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

This study has been completed.
Sponsor:
Information provided by:
Rheoscience A/S
ClinicalTrials.gov Identifier:
NCT00515632
First received: August 13, 2007
Last updated: July 22, 2010
Last verified: July 2010

August 13, 2007
July 22, 2010
July 2007
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00515632 on ClinicalTrials.gov Archive Site
Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: Yes ]
Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin [ Time Frame: baseline and 26 weeks ]
Not Provided
Not Provided
 
Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Balaglitazone
One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.
  • Experimental: Balaglitazone 10 mg per day
    Intervention: Drug: Balaglitazone
  • Experimental: Balaglitazone 20 mg per day
    Intervention: Drug: Balaglitazone
  • Active Comparator: Pioglitazone 45 mg per day
    Intervention: Drug: Balaglitazone
  • Placebo Comparator: Placebo
    Intervention: Drug: Balaglitazone
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 PPARγ 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
409
October 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00515632
DRF2593-307, EudraCT No. 2007-002088-29
No
Bente Juel Riis, MD, Rheoscience A/S
Rheoscience A/S
Not Provided
Study Director: Bente J Riis, MD Nordic Bioscience Clinical Studies A/S
Rheoscience A/S
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP