NCT00873561

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel, Dose-Ranging Study to Evaluate The Efficacy, Safety, Tolerability, and Pharmacodynamics of NBI-6024 In Adult and Adolescent Patients With New Onset Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 10 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a Phase II, multicenter (international), randomized, double-blind, placebo-controlled, parallel, dose-ranging study to evaluate the efficacy of multiple doses of an altered peptide ligand, 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. Study drug was administered subcutaneously a total of 26 times over a 24-month period. The first three doses were administered every 2 weeks (induction phase); all subsequent dosing occurred monthly (maintenance phase). Patients returned to the study center to receive study drug and have efficacy and safety assessments collected. The primary efficacy endpoint was the 2-hour peak C-peptide at Month 24. Other secondary analyses included AUC C-peptide, prescribed insulin usage, AUC blood glucose, HbA1c, hypoglycemic events, and hyperglycemic events.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	NBI-6024	0.1, 0.5 or 1 mg NBI-6024 First 3 doses every 2 weeks. Remaining doses given monthly. Total duration of dosing 24 months. Placebo controlled.

Timeline

• Start date: 2001-12-01
• Primary completion: 2006-04-01
• Completion: 2006-07-01
• First posted: 2009-04-01
• Last updated: 2009-04-01

Locations

21 sites across 8 countries: Canada, Czechia, Finland, France, Germany, South Africa, Spain, United Kingdom