A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus

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