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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT00875459
Eligibility Criteria:
Inclusion Criteria:
1. Completed the VIAject™-06J protocol
2. Informed consent must be obtained in writing for all subjects
Exclusion Criteria:
1. History of frequent severe hypoglycemia within the prior six months which prevent study participation at the discretion of the investigator
2. History of known hypersensitivity to any of the components in the study medication
3. Progressive disease likely to prove fatal
4. Known significant hepatic disease or serum AST or ALT values \> 3 X upper limit of normal or bilirubin levels \> 1.5 X upper limit of normal
5. Severe complications of diabetes mellitus including a history or finding of Stage III or IV diabetic retinopathy (see Appendix B), proteinuria \> 2+ by urine dipstick, serum creatinine of \>1.8 mg/dl for males or \>1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease, which has resulted in amputation or recent onset of chronic foot ulcers or claudication, or the recent, clinically documented loss a pedal pulse.
6. History of moderate to severe ketoacidosis within the 3 months preceding screening for the study
7. Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
8. Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator
9. A sexually active woman of childbearing age not actively and consistently practicing birth control by using a medically accepted device or therapy or a woman intending to become pregnant during the study
10. Abnormal ECG, safety lab or physical examination results which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
11. A history of lack of compliance with medical instructions, recent drug or alcohol abuse, or other reasons which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00875459
Study Brief:
Protocol Section:
NCT00875459