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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT01293461
Eligibility Criteria:
Key Inclusion Criteria:
* Give informed consent
* Aged 18 to 55 years (Part 1), Ages 18 to 65 years (Part 2)
* Stable type 1 diabetes mellitus (T1DM) for a minimum of 5 years
* Body mass index of 18-35 kg/m2
* Be C-peptide deficient (assessed by fasting concentration level)
* Normal renal function (assessed by serum creatinine)
* Be in good general health (besides T1DM)
* Have abnormal sural nerve conduction velocity observed bilaterally (Part 2 only)
Key Exclusion Criteria:
* Any significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, or gastrointestinal condition or disease
* Unstable glucose control
* Have had a islet cell, kidney, and/or pancreas transplant
* Blood loss or blood donation within 56 days
* Drug or alcohol abuse (within 2 years) or recreational drug use (within 3 months)
* History or positive test result for Hepatitis B, C, and/or HIV
* Treatment with medication for peripheral neuropathy within 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01293461
Study Brief:
Protocol Section:
NCT01293461