Type 1 Diabetes MellitusPhase 1NCT00873561
A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus
A Phase 1 study testing NBI-6024 in people with Type 1 Diabetes Mellitus, run by Neurocrine Biosciences at 21 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 10 to 35 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- NBI-6024
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 21 sitesin 8 countries
- Study dates
- Dec 2001to Jul 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- Use of an excluded medication/therapy including any of the following:
- Steroids
- Oral hypoglycemic agents
- Chemotherapy and radiation
- Immunosupressants
- Nicotinamide >100 mg per day
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- 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
Trial locations and contacts
21 sites in 8 countries.
21 sites in 8 countries
South Africa6 sites
New Groote Schuur Hospital
Cape Town
Parklands Medical Center
Durban
Center for Diabetes and Endocrinology
Johannesburg
Donald Gordon Medical Center
Johannesburg
Medigate Medical Center
KwaZulu Natal
Helderberg Diabetic Clinic and Practice
Somerset West
Spain4 sites
Hospital Clinic de Barcelona
Barcelona
Hospital de Cruces
Cruces-Baracado
Hospital Materno-Infantil
Málaga
University Hospital Virgen del Rocío
Seville
Canada3 sites
Centre de recherche clinique de Laval
Laval
Children's Hospital of Eastern Ontario
Ottawa, Ontario
Center Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Czechia2 sites
University Hospital and School of Medicine
Olomouc
Faculty Hospital Motol
Prague
Germany2 sites
Diabetes Center for Children and Adolescents
Hanover
Institut für Diabetesforschung
München
About this study
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
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- NBI-6024
- Keywords
- diabetes, type 1, adult, adolescent, new onset
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 Experimental | Active comparator | NBI-6024 0.1 mg Receives: Drug: NBI-6024 |
| 2 Experimental | Active comparator | NBI-6024 0.5 mg Receives: Drug: NBI-6024 |
| 3 Experimental | Active comparator | NBI-6024 1 mg Receives: Drug: NBI-6024 |
| 4 placebo | No intervention | Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: monthly assessments, up to 24 months (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startDec 2001
- Primary completionApr 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Areti Philotheou, MD, Principal investigator, New Groote Schuur Hospital, Capetown, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873561
- Sponsor's protocol ID
- NBI 6024-0101
- Status last verified
- Mar 2009
- First submitted
- 27 Mar 2009
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19690081
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00873561
- Acronym / sponsor ID
- NBI 6024-0101
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes, type 1, adult, adolescent, new onset
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 Experimental | Active comparator | Drug: NBI-6024NBI-6024 0.1 mg |
| 2 Experimental | Active comparator | Drug: NBI-6024NBI-6024 0.5 mg |
| 3 Experimental | Active comparator | Drug: NBI-6024NBI-6024 1 mg |
| 4 placebo | No intervention | –Placebo injection |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (14 listed)
- Use of an excluded medication/therapy including any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBI-60240.1, 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. | Drug | 1 Experimental, 2 Experimental, 3 Experimental |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
- Derived from this study: PubMed 19690081Walter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areti Philotheou, MD principal investigator
New Groote Schuur Hospital, Capetown, South Africa
21 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NBI-6024 in people with Type 1 Diabetes Mellitus, run by Neurocrine Biosciences at 21 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Africa, Spain, Canada, Czechia, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00873561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2009.