A Study to Evaluate NBI-6024 in Adult & Adolescent Patients With New Onset

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00873561
Study type	Interventional
Source	Neurocrine Biosciences
Contact
Status	Completed
Phase	Phase 1
Start date	December 2001
Completion date	July 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04476472` - Omnipod Horizon™ Automated Glucose Control System Preschool Cohort	N/A
Completed	`NCT03635437` - Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes	Phase 1/Phase 2
Completed	`NCT04909580` - Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes	N/A
Active, not recruiting	`NCT00679042` - Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol	Phase 3
Completed	`NCT03293082` - Preschool CGM Use and Glucose Variability in Type 1 Diabetes	N/A
Completed	`NCT04016662` - Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)	Phase 4
Completed	`NCT02527265` - Afrezza Safety and Pharmacokinetics Study in Pediatric Patients	Phase 2
Completed	`NCT03738865` - G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes	Phase 3
Completed	`NCT03240432` - Wireless Innovation for Seniors With Diabetes Mellitus	N/A
Completed	`NCT03168867` - Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)	N/A
Completed	`NCT03674281` - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System	N/A
Completed	`NCT03669770` - Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
Recruiting	`NCT03682640` - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes	Phase 2
Recruiting	`NCT04096794` - Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Completed	`NCT02882737` - The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus	N/A
Recruiting	`NCT02745808` - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes	Phase 1
Completed	`NCT02596204` - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring	N/A
Withdrawn	`NCT02518022` - How to be Safe With Alcoholic Drinks in Diabetes	N/A
Completed	`NCT02558491` - Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM	N/A
Completed	`NCT02562313` - A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms