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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01881958
Eligibility Criteria:
Inclusion Criteria:
1. Fasting C-peptide levels \>= 0.2nmol/L.
2. Diagnosis of type 1 diabetes
3. No pregnancies or planned pregnancies of female subjects
Exclusion Criteria:
1. The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject's response to treatment or the ability to complete the study.
2. The subject has a history of any kind of malignant tumor (not including basal cell skin cancer).
3. The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject's participation in and/or completion of the study.
4. Subject has history of endogenous allergic reactivity:
* Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to the Screening-Ext Visit.
* Ongoing systemic asthma treatment.
* Subjects with history of life threatening or severe allergy, re-occurrence of which cannot be ruled out based on the Investigator's judgment.
5. The subject has known allergy to lipid emulsions.
6. The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
7. The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy or any medication that in the opinion of the Investigator might interfere with the study.
8. The subject has any of the following clinically significant laboratory abnormalities:
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of the normal (ULN) at the Screening-Ext Visit.
* Total bilirubin greater than 1.3 times the ULN at the Screening-Ext Visit.
* Subjects with severe renal failure at the Screening-Ext visit (as defined by glomerular filtration rate \< 30 mL/min/1.73 m2 by Cockroft und Gault calculation • Clinically significant laboratory abnormalities, confirmed by repeat measurement, which may interfere with the assessment of safety and / or efficacy of the study drug, other than hyperglycemia and glycosuria at the Screening-Ext Visit.
* Fasting triglycerides \<1000 mg/dL (11.3 mmol/L) at the Screening-Ext Visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
9. The subject is a known or suspected drug abuser.
10. The subject is known to test positive for HIV antibodies.
11. The subject has chronic hematologic disease.
12. The subject has liver disease such as cirrhosis or chronic active hepatitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01881958
Study Brief:
Protocol Section:
NCT01881958