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NBI-6024

Phase 1

Type 1 Diabetes Mellitus | Small molecule | Metabolic |Neurocrine Biosciences, Inc.|Last Updated: Apr 1, 2009

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment188
FDA Designations
No designations recorded
Clinical trial landscape

NBI-6024 · 1 trial · 1 indication

Phase 1 1
NCT00873561A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes MellitusType 1 Diabetes Mellitus
COMPLETED188 Analytics
PHASE1COMPLETED
A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus
NCT00873561188
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Study Endpoints
Primary Endpoints
To assess the effect of repeated administrations of NBI-6024 on endogenous insulin production as measured by C-peptide levels in adult and adolescent patients with new onset type 1 diabetes mellitus
monthly assessments, up to 24 months (end of study)
Secondary Endpoints
To examine the effects of repeated administrations of NBI-6024 on insulin usage, glycemic control, and immune function (immunodynamics and pharmacodynamics) To examine the safety and tolerability of repeated administrations of NBI-6024
monthly assessments, up to 24 months (end of study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1 ExperimentalACTIVE_COMPARATORNBI-6024 0.1 mg
2 ExperimentalACTIVE_COMPARATORNBI-6024 0.5 mg
3 ExperimentalACTIVE_COMPARATORNBI-6024 1 mg
4 placeboNO_INTERVENTIONPlacebo injection
Interventions
NameTypeDescription
NBI-6024DRUG0.1, 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.
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Eligibility Criteria
Age Range10 Years to 35 Years
SexALL
Healthy VolunteersNo
Study Sites21

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 ...

Countries:CanadaCzechiaFinlandFranceGermanySouth AfricaSpainUnited Kingdom
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