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 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT00873561
Eligibility Criteria:
Inclusion Criteria:
* Male or female between the age of 12 and 35 years, inclusive (changed to between the age of 10 and 35 years, inclusive, under Amendment 2)
* If female of childbearing potential, patient must use an acceptable method of birth control prior to and for 30 days post study
* Adult (greater than or equal to 18 years) female patients who were not of childbearing potential must be 2 years postmenopausal, or have had a hysterectomy or tubal ligation
* Were newly diagnosed with type 1 diabetes mellitus
* Presence of one or more of the following:
* Anti-ICA512 antibodies
* Anti-GAD antibodies
* Anti-insulin antibodies, provided that the patient was not on insulin therapy for greater than 1 week
* Body mass index (BMI) \< 28 kg/m2
* Stimulated serum C-peptide peak level between 0.4 pmol/mL and 3.0 pmol/mL, inclusive, at the time of screening
* Laboratory and 12-lead electrocardiogram (ECG) results within normal ranges or, if abnormal, considered by the investigator as non clinically significant for the safety and well being of the patient or for the purposes of the study
Exclusion Criteria:
* Use of an excluded medication/therapy including any of the following:
* Steroids
* Oral hypoglycemic agents
* Chemotherapy and radiation
* Immunosupressants
* Nicotinamide \>100 mg per day
* Any drugs containing sibutramine
* Female patients with a positive pregnancy test or who are lactating
* Adult patients with body weight \<45 kg; adolescent patients with body weight \<30 kg; 10- and 11-year-old patients with body weight \<25 kg
* History of cancer or have existing or actively managed cancer
* History of severe or anaphylactic allergic reactions
* Patients suffering from active skin infections that would prevent subcutaneous injection
* Positive test for HIV antigens, hepatitis B surface antigen, or hepatitis C antibodies
* History of alcohol or substance abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
35 Years
Study:
NCT00873561
Study Brief:
Protocol Section:
NCT00873561