Diabetes MellitusPhase 2NCT01322321
ACZ885 in Type 1 Diabetes Mellitus
A Phase 2 study testing ACZ885 in people with Diabetes Mellitus and Diabetes Type 1, run by Novartis Pharmaceuticals at 10 sites in 4 countries.
Trial summary
This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 6 to 35 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Type 1
- What is being tested?
- ACZ885
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Mar 2011to Jun 2011
- 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 6 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen
- presence of at least one diabetes-related autoantibody
- qualifying C-peptide value in a mixed meal test at visit 1
- willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug
- body weight of at least 30 kg
Who cannot join
- women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc)
- immunodeficiency
- active infections or febrile illness within 3 days before visit 1
- major dental work within 8 days before visit 1
- positive test for tuberculosis at visit 1
- use of medications other than insulin for the treatment of diabetes Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United Kingdom4 sites
Novartis Investigative Site
Bristol
Novartis Investigative Site
Exeter
Novartis Investigative Site
Hull
Novartis Investigative Site
Liverpool
Germany3 sites
Novartis Investigative Site
Düsseldorf
Novartis Investigative Site
Hanover
Novartis Investigative Site
Neuwied
Canada2 sites
LMC Endocrinology Centres (Barrie) Ltd
Barrie, Ontario
LMC Endocrinology Centres (Bayview) Ltd
Toronto, Ontario
United States1 site
Aurora St Luke's Medical Center, Endocrine & Diabetes Center
Milwaukee, Wisconsin
About this study
Official title: A Randomized, Double-blind, Multiple-dose, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ACZ885 in Patients With Newly Diagnosed Type-1 Diabetes Mellitus (T1DM)
This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Diabetes Type 1
- Being tested
- ACZ885, Placebo
- Keywords
- ACZ885, diabetes, type 1, C-peptide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACZ885Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ACZ885 | Experimental | Not described Receives: Drug: ACZ885 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months
Measured: at 13 months
Secondary outcomes (5)
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 4, 7, 10, 18, 24, 30 and 36 months
Measured: 36 months
Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months
Measured: 36 months
Measure: number of hypoglycemic events
Measured: 36 months
Measure: daily insulin dose
Measured: 36 months
Measure: anti-ACZ885 antibodies
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322321
- Sponsor's protocol ID
- CACZ885I2208
- Other IDs
- 2010-020166-20
- Status last verified
- Sep 2012
- First submitted
- 22 Mar 2011
- Last updated
- 5 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multiple-dose, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ACZ885 in Patients With Newly Diagnosed Type-1 Diabetes Mellitus (T1DM)
- ClinicalTrials.gov ID
- NCT01322321
- Acronym / sponsor ID
- CACZ885I2208
- Conditions
- Diabetes Mellitus, Diabetes Type 1
- Keywords
- ACZ885, diabetes, type 1, C-peptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (estimated)
- First posted
- 24 Mar 2011 (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 study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACZ885 | Experimental | Drug: ACZ885 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen
- presence of at least one diabetes-related autoantibody
- qualifying C-peptide value in a mixed meal test at visit 1
- willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug
- body weight of at least 30 kg
Key exclusion criteria (6 listed)
- women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc)
- immunodeficiency
- active infections or febrile illness within 3 days before visit 1
- major dental work within 8 days before visit 1
- positive test for tuberculosis at visit 1
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 |
|---|---|---|
| ACZ885 | Drug | ACZ885 |
| Placebo | Drug | Placebo |
Primary outcome
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months
Time frame: at 13 months
5 secondary outcomes
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 4, 7, 10, 18, 24, 30 and 36 months
Time frame: 36 months
Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months
Time frame: 36 months
Measure: number of hypoglycemic events
Time frame: 36 months
Measure: daily insulin dose
Time frame: 36 months
Measure: anti-ACZ885 antibodies
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACZ885 in people with Diabetes Mellitus and Diabetes Type 1, run by Novartis Pharmaceuticals at 10 sites in 4 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Germany, Canada, 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months (time frame: at 13 months). 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 5 Sep 2012.