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:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT00562133
Eligibility Criteria:
Inclusion Criteria:
1. Type 2 Diabetes mellitus according to the ADA criteria
2. HbA1c between 6.5 % and 9.9 %
3. Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months
4. Age between 40 and 70 years
5. BMI \< 40
Exclusion Criteria:
1. Type 1 Diabetes mellitus
2. Pre-Treatment with insulin within the last 6 months prior to screening
3. Treatment with glitazones within the last 6 months prior to screening
4. Pre-Treatment with PPARy-agonists, glinides or glucosidase inhibitors within the last 4 weeks prior to screening
5. Untreated hypertension stage II-III according to WHO criteria
6. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
7. Total Cholesterol \> 300 mg/dl (anamnestically)
8. Hypokalemia (K \< 3.5 mmol /l)
9. Major micro- or macrovascular complications as judged by the investigator
10. Tobacco use within the last 12 months prior to screening
11. Drugs with major impact on endothelial function like nitrates etc.
12. History of drug or alcohol abuse within the last five years prior to screening
13. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
14. History of severe or multiple allergies
15. Treatment with any other investigational drug within 3 months prior to screening
16. Progressive fatal disease
17. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.1 mg/dL in women, \> 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
18. Pregnancy or breast feeding
19. Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
20. Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00562133
Study Brief:
Protocol Section:
NCT00562133