Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT00515632
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00515632
Study Brief:
Protocol Section:
NCT00515632