Newly Diagnosed With Type 1 DiabetesPhase 2NCT00198146
Prevention of Diabetes Progression Trial (PDPT)
A Phase 2 study testing Zenapax in people with Newly Diagnosed With Type 1 Diabetes, run by Indiana University at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type I diabetes. Read more about this study
- Who is it for?
- Ages 2 to 40 years
- Conditions the study is for
- Newly Diagnosed With Type 1 Diabetes
- What is being tested?
- Zenapax
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to 23 Feb 2007
- Phase
- Phase 2
- 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 2 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed type 1 diabetes without previous insulin or oral hypoglycemic therapy.
- ages 2 to 40 years at diagnosis
- enroll within 3 months of diagnosis
- test positive for at least one of the biochemical autoantibodies (ICA-512, GAD 65 or IAA) prior to enrolling
Who cannot join
- Previous treatment with an anti-IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety and efficacy of daclizumab.
- Other immunosuppressive drugs including, but not limited to, corticosteroids, cyclosporine, tacrolimus, rapamycin, mycophenolate mofetil, or azathioprine.
- Active significant infection
- Limited life expectancy because of disease other than diabetes
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: PD Initiated/Prevention of Diabetes Progression Trial (PDPT) ZEN119
The primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type I diabetes. Additional purposes of the study are to investigate the amount of drug in the children, how quickly it is eliminated from the blood, and analyze the effect of the drug on the immune reaction to diabetes.
- Conditions
- Newly Diagnosed With Type 1 Diabetes
- Being tested
- Zenapax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZenapaxDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years
Secondary outcomes (2)
HbA1c
Insulin requirements (units/kg/day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2000
- Primary completion23 Feb 2007
- Study completion23 Feb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed With Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Pescovitz, Mark D., M.D., Roche Pharma AG, Facet Biotech
- Investigators
- Mark D Pescovitz, M.D., Principal investigator, Indiana University - Riley Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198146
- Sponsor's protocol ID
- 9910-34
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 11 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD Initiated/Prevention of Diabetes Progression Trial (PDPT) ZEN119
- ClinicalTrials.gov ID
- NCT00198146
- Acronym / sponsor ID
- 9910-34
- Conditions
- Newly Diagnosed With Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Pescovitz, Mark D., M.D., Roche Pharma AG, Facet Biotech
- Study start
- Jul 2000
- Primary completion
- 23 Feb 2007 (actual)
- Study completion
- 23 Feb 2007 (actual)
- First posted
- 20 Sep 2005 (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.
The primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type I diabetes. Additional purposes of the study are to investigate the amount of drug in the children, how quickly it is eliminated from the blood, and analyze the effect of the drug on the immune reaction to diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Newly diagnosed type 1 diabetes without previous insulin or oral hypoglycemic therapy.
- ages 2 to 40 years at diagnosis
- enroll within 3 months of diagnosis
- test positive for at least one of the biochemical autoantibodies (ICA-512, GAD 65 or IAA) prior to enrolling
Key exclusion criteria (5 listed)
- Previous treatment with an anti-IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety and efficacy of daclizumab.
- Other immunosuppressive drugs including, but not limited to, corticosteroids, cyclosporine, tacrolimus, rapamycin, mycophenolate mofetil, or azathioprine.
- Active significant infection
- Limited life expectancy because of disease other than diabetes
- Pregnancy
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 |
|---|---|---|
| Zenapax | Drug | – |
Primary outcome
Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years
2 secondary outcomes
HbA1c
Insulin requirements (units/kg/day)
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 11 Aug 2020.
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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.
Mark D Pescovitz, M.D. principal investigator
Indiana University - Riley Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zenapax in people with Newly Diagnosed With Type 1 Diabetes, run by Indiana University at 1 site in United States.
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 4 inclusion and 5 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 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2020.