NCT00873561

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_1

Geographic Reach
8 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
Last Updated

April 1, 2009

Status Verified

March 1, 2009

Enrollment Period

4.3 years

First QC Date

March 27, 2009

Last Update Submit

March 30, 2009

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetestype 1adultadolescentnew onset

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Study Arms (4)

1 Experimental

ACTIVE COMPARATOR

NBI-6024 0.1 mg

Drug: NBI-6024

2 Experimental

ACTIVE COMPARATOR

NBI-6024 0.5 mg

Drug: NBI-6024

3 Experimental

ACTIVE COMPARATOR

NBI-6024 1 mg

Drug: NBI-6024

4 placebo

NO INTERVENTION

Placebo injection

Interventions

NBI-6024DRUG

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.

1 Experimental2 Experimental3 Experimental

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Location

Center Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Centre de recherche clinique de Laval

Laval, Canada

Location

University Hospital and School of Medicine

Olomouc, Czechia

Location

Faculty Hospital Motol

Prague, Czechia

Location

Helsinki University Hospital

Helsinki, Finland

Location

Hôpital Debrousse

Lyon, France

Location

Hôpital St Vincent de Paul

Paris, France

Location

Diabetes Center for Children and Adolescents

Hanover, Germany

Location

Institut für Diabetesforschung

München, Germany

Location

New Groote Schuur Hospital

Cape Town, South Africa

Location

Parklands Medical Center

Durban, South Africa

Location

Center for Diabetes and Endocrinology

Johannesburg, South Africa

Location

Donald Gordon Medical Center

Johannesburg, South Africa

Location

Medigate Medical Center

KwaZulu Natal, South Africa

Location

Helderberg Diabetic Clinic and Practice

Somerset West, South Africa

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital de Cruces

Cruces-Baracado, Spain

Location

Hospital Materno-Infantil

Málaga, Spain

Location

University Hospital Virgen del Rocío

Seville, Spain

Location

Maternal and Child Health Services 2

Dundee, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19690081DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

NBI6024

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Areti Philotheou, MD

    New Groote Schuur Hospital, Capetown, South Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2009

First Posted

April 1, 2009

Study Start

December 1, 2001

Primary Completion

April 1, 2006

Study Completion

July 1, 2006

Last Updated

April 1, 2009

Record last verified: 2009-03

Locations

FI(1)DE(2)CA(3)ZA(6)ES(4)CZ(2)GB(1)FR(2)