MedTrace Logo

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

NCT00873561 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2009-04-01

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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.

Sponsors & Collaborators

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Areti Philotheou, MD · New Groote Schuur Hospital, Capetown, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2006-04-30
Completion
2006-07-31

Countries

  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00873561 on ClinicalTrials.gov