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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Balaglitazone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Rheoscience A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 409
Study Start Date: July 2007
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Balaglitazone 10 mg per day Drug: Balaglitazone
One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.
Experimental: Balaglitazone 20 mg per day Drug: Balaglitazone
One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.
Active Comparator: Pioglitazone 45 mg per day Drug: Balaglitazone
One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.
Placebo Comparator: Placebo Drug: Balaglitazone
One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515632

Locations
Denmark
Multi-center
Copenhagen, Denmark
Sponsors and Collaborators
Rheoscience A/S
Investigators
Study Director: Bente J Riis, MD Nordic Bioscience Clinical Studies A/S
  More Information

No publications provided by Rheoscience A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bente Juel Riis, MD, Rheoscience A/S
ClinicalTrials.gov Identifier: NCT00515632     History of Changes
Other Study ID Numbers: DRF2593-307, EudraCT No. 2007-002088-29
Study First Received: August 13, 2007
Last Updated: July 22, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rheoscience A/S:
Type 2 diabetes mellitus on Stable insulin therapy
Balaglitazone
Pioglitazone (Actos®)
HbA1c
Weight gain
Oedema
Fasting blood glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014