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

• Conditions: Balglitazone is being developed as an oral anti-diabetic drug to improve glycaemic control in patients with type 2 diabetes; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2007-002088-29-SE
• Lead Sponsor: Rheoscience A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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 during a previous and resolved short term 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified