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

This study has been completed.
Sponsor:
Information provided by:
Neurocrine Biosciences
ClinicalTrials.gov Identifier:
NCT00873561
First received: March 27, 2009
Last updated: March 30, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Drug: NBI-6024
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Neurocrine Biosciences:

Primary Outcome Measures:
  • 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 [ Time Frame: monthly assessments, up to 24 months (end of study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: monthly assessments, up to 24 months (end of study) ] [ Designated as safety issue: Yes ]

Enrollment: 188
Study Start Date: December 2001
Study Completion Date: July 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Experimental
NBI-6024 0.1 mg
 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.
Active Comparator: 2 Experimental
NBI-6024 0.5 mg
 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.
Active Comparator: 3 Experimental
NBI-6024 1 mg
 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.
No Intervention: 4 placebo
Placebo injection

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.

  Eligibility

Ages Eligible for Study:   10 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (greater than or equal to 18 years) female patients who were not of childbearing potential must be 2 years postmenopausal, or have had a hysterectomy or tubal ligation
  • Were newly diagnosed with type 1 diabetes mellitus

  • Presence of one or more of the following:

    • Anti-ICA512 antibodies
    • Anti-GAD antibodies
    • Anti-insulin antibodies, provided that the patient was not on insulin therapy for greater than 1 week
  • Body mass index (BMI) < 28 kg/m2
  • Stimulated serum C-peptide peak level between 0.4 pmol/mL and 3.0 pmol/mL, inclusive, at the time of screening
  • Laboratory and 12-lead electrocardiogram (ECG) results within normal ranges or, if abnormal, considered by the investigator as non clinically significant for the safety and well being of the patient or for the purposes of the study

Exclusion Criteria:

  • Use of an excluded medication/therapy including any of the following:

    • Steroids
    • Oral hypoglycemic agents
    • Chemotherapy and radiation
    • Immunosupressants
    • Nicotinamide >100 mg per day
    • Any drugs containing sibutramine
  • Female patients with a positive pregnancy test or who are lactating
  • Adult patients with body weight <45 kg; adolescent patients with body weight <30 kg; 10- and 11-year-old patients with body weight <25 kg
  • History of cancer or have existing or actively managed cancer
  • History of severe or anaphylactic allergic reactions
  • Patients suffering from active skin infections that would prevent subcutaneous injection
  • Positive test for HIV antigens, hepatitis B surface antigen, or hepatitis C antibodies
  • History of alcohol or substance abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873561

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Canada, Quebec
Center Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Canada
Centre de recherche clinique de Laval
Laval, Canada
Czech Republic
University Hospital and School of Medicine
Olomouc, Czech Republic
Faculty Hospital Motol
Prague, Czech Republic
Finland
Helsinki University Hospital
Helsinki, Finland
France
Hôpital Debrousse
Lyons, France
Hôpital St Vincent de Paul
Paris, France
Germany
Diabetes Center for Children and Adolescents
Hannover, Germany
Institut für Diabetesforschung
Munchen, Germany
South Africa
New Groote Schuur Hospital
Cape Town, South Africa
Parklands Medical Center
Durban, South Africa
Center for Diabetes and Endocrinology
Johannesburg, South Africa
Donald Gordon Medical Center
Johannesburg, South Africa
Medigate Medical Center
KwaZulu Natal, South Africa
Helderberg Diabetic Clinic and Practice
Somerset West, South Africa
Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de Cruces
Cruces-Baracado, Spain
Hospital Materno-Infantil
Malaga, Spain
University Hospital Virgen del Rocío
Sevilla, Spain
United Kingdom
Maternal and Child Health Services 2
Dundee, United Kingdom
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
Principal Investigator: Areti Philotheou, MD New Groote Schuur Hospital, Capetown, South Africa
  More Information

No publications provided by Neurocrine Biosciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chris O'Brien, Chief Medical Office and VP of Clinical Development, Neurocrine Biosciences Inc
ClinicalTrials.gov Identifier: NCT00873561     History of Changes
Other Study ID Numbers: NBI 6024-0101
Study First Received: March 27, 2009
Last Updated: March 30, 2009
Health Authority: Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Neurocrine Biosciences:
diabetes
type 1
adult
adolescent
new onset

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013