Type 1 DiabetesPhase 2TN14NCT00947427
Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
A Phase 2 study testing canakinumab (anti IL-1beta) in people with Type 1 Diabetes and Preservation of Insulin Secretion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 12 sites in 2 countries.
Trial summary
Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine. Read more about this study
- Who is it for?
- Ages 6 to 45 years
- Conditions the study is for
- Type 1 Diabetes, Preservation of Insulin Secretion, Newly Diagnosed Type 1 Diabetes
- What is being tested?
- canakinumab (anti IL-1beta)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Oct 2010to Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 6-45 years
- Be within 3-months (100 days) of diagnosis of type 1 diabetes
- Must have at least one diabetes-related autoantibody present
- Must have stimulated C-peptide levels >0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
- If participant is female with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test during the 12 months of treatment and for an additional 3 months after completing treatment
- Be at least one month from time of last live immunization received
Show all 9Show fewer
- Willing to forgo live vaccinations for 24 months
- Must be willing to comply with intensive diabetes management
- Must weigh at least 20 kg (44 lbs) at study entry
Who cannot join
- Are immunodeficient or have clinically significant chronic lymphopenia (low white blood cell count)
- Have an active infection
- Have a positive PPD test result
- Be currently pregnant or lactating, or anticipate getting pregnant
- Ongoing use of medications known to influence glucose tolerance
- Require use of other immunosuppressive agents
Show all 9Show fewer
- Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C infection
- Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
- Be currently participating in another type 1 diabetes treatment study
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
University of Texas-Southwestern Medical School
Dallas, Texas, 75235
University of Florida
Gainesville, Florida, 32610-
Indiana University-Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Miami School of Medicine
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 57931
Yale Medical School
New Haven, Connecticut
Columbia University
New York, New York
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California-San Francisco
San Francisco, California, 94143
Benaroya Research Institute
Seattle, Washington, 98101
Stanford University
Stanford, California, 94305
About this study
Official title: Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects
Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine.
The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive standard intensive diabetes treatment with insulin and dietary management.
Read more
Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12 injections over one year.
All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up until study end. Enrollment is expected to occur over two years.
- Conditions
- Type 1 Diabetes, Preservation of Insulin Secretion, Newly Diagnosed Type 1 Diabetes, Canakinumab in Type 1 Diabetes
- Being tested
- canakinumab (anti IL-1beta), Placebo
- Keywords
- type 1 diabetes, newly diagnosed T1D, T1D, canakinumab, anti IL-1
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
canakinumab (anti IL-1beta)Drug
Also called canakinumab, anti IL-1beta
canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
PlaceboDrug
Placebo subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo solution given by subcutaneous injection on monthly basis for 12 months Receives: Drug: Placebo |
| Canakinumab | Experimental | Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months Receives: Drug: canakinumab (anti IL-1beta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo
The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startOct 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947427
- Sponsor's protocol ID
- TN14 Cana
- Other IDs
- UC4DK097835
- Acronym
- TN14
- Status last verified
- Apr 2020
- First submitted
- 24 Jul 2009
- Last updated
- 6 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available at the NIDDK Central Repository:https://repository.niddk.nih.gov/studies/tn14-anti-il-1-beta/?query=TN14
Publications
Moran A, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Greenbaum CJ, Herold KC, Marks JB, Raskin P, Sanda S, Schatz D, Wherrett DK, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet Canakinumab Study Group; Pickersgill L, de Koning E, Ziegler AG, Boehm B, Badenhoop K, Schloot N, Bak JF, Pozzilli P, Mauricio D, Donath MY, Castano L, Wagner A, Lervang HH, Perrild H, Mandrup-Poulsen T; AIDA Study Group. Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials. Lancet. 2013 Jun 1;381(9881):1905-15. doi: 10.1016/S0140-6736(13)60023-9. Epub 2013 Apr 5.
PubMed 23562090
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects
- ClinicalTrials.gov ID
- NCT00947427
- Acronym / sponsor ID
- TN14 / TN14 Cana
- Conditions
- Type 1 Diabetes, Preservation of Insulin Secretion, Newly Diagnosed Type 1 Diabetes, Canakinumab in Type 1 Diabetes
- Keywords
- type 1 diabetes, newly diagnosed T1D, T1D, canakinumab, anti IL-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Oct 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Posted 18 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine.
The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive standard intensive diabetes treatment with insulin and dietary management.
Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12 injections over one year.
All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up until study end. Enrollment is expected to occur over two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution given by subcutaneous injection on monthly basis for 12 months |
| Canakinumab | Experimental | Drug: canakinumab (anti IL-1beta)Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months |
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Between the ages of 6-45 years
- Be within 3-months (100 days) of diagnosis of type 1 diabetes
- Must have at least one diabetes-related autoantibody present
- Must have stimulated C-peptide levels >0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
- If participant is female with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test during the 12 months of treatment and for an additional 3 months after completing treatment
Key exclusion criteria (9 listed)
- Are immunodeficient or have clinically significant chronic lymphopenia (low white blood cell count)
- Have an active infection
- Have a positive PPD test result
- Be currently pregnant or lactating, or anticipate getting pregnant
- Ongoing use of medications known to influence glucose tolerance
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 |
|---|---|---|
| canakinumab (anti IL-1beta)Also: canakinumab, anti IL-1betacanakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months | Drug | Canakinumab |
| PlaceboPlacebo subcutaneous injections | Drug | Placebo |
Primary outcome
C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo
Time frame: 12 months
The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23562090Moran A, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Greenbaum CJ, Herold KC, Marks JB, Raskin P, Sanda S, Schatz D, Wherrett DK, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet Canakinumab Study Group; Pickersgill L, de Koning E, Ziegler AG, Boehm B, Badenhoop K, Schloot N, Bak JF, Pozzilli P, Mauricio D, Donath MY, Castano L, Wagner A, Lervang HH, Perrild H, Mandrup-Poulsen T; AIDA Study Group. Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials. Lancet. 2013 Jun 1;381(9881):1905-15. doi: 10.1016/S0140-6736(13)60023-9. Epub 2013 Apr 5.
- Individual participant dataSharing planned: Yes. Data are available at the NIDDK Central Repository:https://repository.niddk.nih.gov/studies/tn14-anti-il-1-beta/?query=TN14
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing canakinumab (anti IL-1beta) in people with Type 1 Diabetes and Preservation of Insulin Secretion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 12 sites in 2 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 9 inclusion and 9 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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 18 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo (time frame: 12 months). 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 NCT00947427, 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 6 May 2020.