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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT01581658
Eligibility Criteria:
Inclusion criteria:
* Type 2 diabetes patients
* Glycosylated haemoglobin\>= 6.1% (Japan Diabetes Society)
* Estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of \>= 15 mL/min/1.73m2
Exclusion criteria:
* Any evidence of significant disease (other than renal impairment)
* Moderate and severe concurrent liver function impairment
* Gastrointestinal tract surgery, that might affect absorption and elimination of drugs
* Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
* Chronic or relevant acute infections
* Participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01581658
Study Brief:
Protocol Section:
NCT01581658