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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NBI-6024
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes Mellitus focused on measuring diabetes, type 1, adult, adolescent, new onset

Eligibility Criteria

10 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Eastern Ontario
  • Center Hospitalier Universitaire de Sherbrooke
  • Centre de recherche clinique de Laval
  • University Hospital and School of Medicine
  • Faculty Hospital Motol
  • Helsinki University Hospital
  • Hôpital Debrousse
  • Hôpital St Vincent de Paul
  • Diabetes Center for Children and Adolescents
  • Institut für Diabetesforschung
  • New Groote Schuur Hospital
  • Parklands Medical Center
  • Center for Diabetes and Endocrinology
  • Donald Gordon Medical Center
  • Medigate Medical Center
  • Helderberg Diabetic Clinic and Practice
  • Hospital Clinic de Barcelona
  • Hospital de Cruces
  • Hospital Materno-Infantil
  • University Hospital Virgen del Rocío
  • Maternal and Child Health Services 2

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

1 Experimental

2 Experimental

3 Experimental

4 placebo

Arm Description

NBI-6024 0.1 mg

NBI-6024 0.5 mg

NBI-6024 1 mg

Placebo injection

Outcomes

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

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

Full Information

First Posted
March 27, 2009
Last Updated
March 30, 2009
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT00873561
Brief Title
A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neurocrine Biosciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
diabetes, type 1, adult, adolescent, new onset

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Experimental
Arm Type
Active Comparator
Arm Description
NBI-6024 0.1 mg
Arm Title
2 Experimental
Arm Type
Active Comparator
Arm Description
NBI-6024 0.5 mg
Arm Title
3 Experimental
Arm Type
Active Comparator
Arm Description
NBI-6024 1 mg
Arm Title
4 placebo
Arm Type
No Intervention
Arm Description
Placebo injection
Intervention Type
Drug
Intervention Name(s)
NBI-6024
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areti Philotheou, MD
Organizational Affiliation
New Groote Schuur Hospital, Capetown, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Center Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Centre de recherche clinique de Laval
City
Laval
Country
Canada
Facility Name
University Hospital and School of Medicine
City
Olomouc
Country
Czech Republic
Facility Name
Faculty Hospital Motol
City
Prague
Country
Czech Republic
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Hôpital Debrousse
City
Lyons
Country
France
Facility Name
Hôpital St Vincent de Paul
City
Paris
Country
France
Facility Name
Diabetes Center for Children and Adolescents
City
Hannover
Country
Germany
Facility Name
Institut für Diabetesforschung
City
Munchen
Country
Germany
Facility Name
New Groote Schuur Hospital
City
Cape Town
Country
South Africa
Facility Name
Parklands Medical Center
City
Durban
Country
South Africa
Facility Name
Center for Diabetes and Endocrinology
City
Johannesburg
Country
South Africa
Facility Name
Donald Gordon Medical Center
City
Johannesburg
Country
South Africa
Facility Name
Medigate Medical Center
City
KwaZulu Natal
Country
South Africa
Facility Name
Helderberg Diabetic Clinic and Practice
City
Somerset West
Country
South Africa
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de Cruces
City
Cruces-Baracado
Country
Spain
Facility Name
Hospital Materno-Infantil
City
Malaga
Country
Spain
Facility Name
University Hospital Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Maternal and Child Health Services 2
City
Dundee
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19690081
Citation
Walter M, Philotheou A, Bonnici F, Ziegler AG, Jimenez R; NBI-6024 Study Group. No effect of the altered peptide ligand NBI-6024 on beta-cell residual function and insulin needs in new-onset type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2036-40. doi: 10.2337/dc09-0449. Epub 2009 Aug 18.
Results Reference
derived

Learn more about this trial

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

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