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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002088-29-DK

Enrollment

400

Registered

2007-05-15

Start date

2007-08-22

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balaglitazone is being developed as an oral anti-diabetic drug to improve glycaemic control in patients with type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Product Name: Balaglitazone Product Code: DRF2593 Pharmaceutical Form: Capsule* INN or Proposed INN: Balaglitazone CAS Number: 199144-17-5 Current Sponsor code: DRF-2593 Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion 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 on stable dose of at least 30 U/day (± 4 U/day), for at least 75 days (insulin adjustments are during a previous and resolved short trem acute disease are permitted). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Prior or current use of PPAR-? agonist 2. Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention 3. Diagnosed or receiving medication for heart failure, NYHA I to IV 4. Uncontrolled treated/untreated systolic > 180 mmHg and/or diastolic blood pressure > 95 mmHg 5. Serum creatinine > 130 µmol/L 6. ALT, AST, total bilirubin or alkaline phosphatase = 2.5 times the upper limit of normal 7. 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 8. Hematuria, defined as any, even trace of, hematuri on a urinary dipstick at the screening or randomisation visit 9. Contraindication/intolerance to study medication 10. Pre-existing medical condition judged to preclude safe participation in the study 11. Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol 12. Recent use (< 3 months) of an investigational drug 13. Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives). 14. Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation 15. Use of any drug which in the Investigator’s opinion could interfere with the glucose level (e.g. systemic corticosteroids). 16. Any cancer history or currently diagnosed/treated cancer 17. Diagnosis of clinically significant disease/disorder which in the Investigator’s opinion could interfere with the results of the trial 18. Known Diabetic macular oedema 19. Planned surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare, in type 2 diabetes patients on stable insulin therapy, the efficacy of balaglitazone 10 mg and 20 mg against placebo on absolute change in HbA1c from baseline to end of trial. ;Secondary Objective: To assess and compare the effect of balaglitazone against pioglitazone 45 mg or placebo on various pharmacodynamic measurements in patients with type 2 diabetes on stable insulin therapy from baseline to end of trial. The secondary outcome measures include changes in; 1. Fasting plasma glucose, 4- and 7-point plasma glucose profiles 2. Percentage/proportion of patients achieving an HbA1c <7.0% or <6.5% 3. Blood lipid profile (TG, TC, LDL-C, HDL-C, LDL/HDL) 4. Body weight gain 5. Waist and hip circumferences 6. Plasma volume and plasma NT-proBNP 7. Frequency of lower leg oedema by clinical assessment or by water displacement 8. Change in body composition, as measured by DXA, as a measure of changes in fat tissue mass and Lean tissue mass, i.e. fluid retention 9. Daily dose of insulin ;Primary end point(s): To compare, in type 2 diabetes patients on stable insulin therapy, the efficacy of balaglitazone 10 mg and 20 mg against placebo on absolute change in HbA1c from baseline to end of trial	—

Measure

Time frame

Main Objective: To compare, in type 2 diabetes patients on stable insulin therapy, the efficacy of balaglitazone 10 mg and 20 mg against placebo on absolute change in HbA1c from baseline to end of trial. ;Secondary Objective: To assess and compare the effect of balaglitazone against pioglitazone 45 mg or placebo on various pharmacodynamic measurements in patients with type 2 diabetes on stable insulin therapy from baseline to end of trial. The secondary outcome measures include changes in; 1. Fasting plasma glucose, 4- and 7-point plasma glucose profiles 2. Percentage/proportion of patients achieving an HbA1c <7.0% or <6.5% 3. Blood lipid profile (TG, TC, LDL-C, HDL-C, LDL/HDL) 4. Body weight gain 5. Waist and hip circumferences 6. Plasma volume and plasma NT-proBNP 7. Frequency of lower leg oedema by clinical assessment or by water displacement 8. Change in body composition, as measured by DXA, as a measure of changes in fat tissue mass and Lean tissue mass, i.e. fluid retention 9. Daily dose of insulin ;Primary end point(s): To compare, in type 2 diabetes patients on stable insulin therapy, the efficacy of balaglitazone 10 mg and 20 mg against placebo on absolute change in HbA1c from baseline to end of trial

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Countries

Denmark, Finland, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026