A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus
Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
Participant gender:
Summary
This was a study designed to evaluate the efficacy of multiple doses of an investigational
drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age)
patients with new onset type 1 diabetes mellitus, on endogenous insulin production.
A total of 188 patients were enrolled in the study. The study was divided into three periods:
screening, treatment (comprising an induction phase and maintenance phase), and follow-up.
NBI-6024 was generally well tolerated and exhibits a benign safety profile, as there were no
significant safety issues with NBI-6024 treatment. In summary, NBI-6024 did not demonstrate
statistically significant efficacy compared with placebo.