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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT00789035
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients with a diagnosis of type 2 diabetes mellitus
* either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
* HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c \>7.0 to ≤10.0%
* HbA1c \>7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
* Age between 18 and 80 years
* BMI less than 40 kg/m2
* Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion Criteria:
1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent
2. Impaired hepatic function
3. Renal insufficiency or impaired renal function
4. Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
5. Chronic or clinically relevant acute infections
6. Current or chronic urogenital tract infection determined by medical history
7. History of clinically relevant allergy/hypersensitivity
8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
9. Treatment with anti obesity drugs
10. Current treatment with systemic steroids
11. Alcohol abuse
12. Treatment with an investigational drug within 2 months prior to informed consent
13. known intolerance to metformin
14. Dehydration
15. Unstable or acute CHF
16. Acute or chronic acidosis
17. Hereditary galactose intolerance
18. Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00789035
Study Brief:
Protocol Section:
NCT00789035