Type 1 Diabetes MellitusPhase 1NCT00607230
Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
A Phase 1 study testing BCG and Saline in people with Type 1 Diabetes Mellitus, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the pancreas. The investigators have discovered the specific autoimmune cells responsible for destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means of destroying those cells. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- BCG and Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Feb 2011
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type 1 diabetes treated continuously with insulin from time of diagnosis
- Age 18-55
- Anti-GAD positive
- HIV antibody negative
- Normal CBC
- Negative intermediate PPD test performed and read by study staff
- HCG Negative (females)
- Age 18-45
Who cannot join
- History of chronic infectious disease, such as HIV
- History of tuberculosis, TB risk factors, or history of + PPD, or BCG vaccination
- Treatment with glucocorticoids (other than intermittent nasal steroids) or disease or condition likely to require steroid therapy
- Other conditions or treatments associated with increased risk of infections such as patients with previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason
- Current treatment with aspirin > 160 mg/day or chronic, daily NSAIDs
- Fasting or stimulated (1 mg glucagon stimulation test) c-peptide > 0.2 pmol/mL
Show all 14Show fewer
- History of keloid formation
- HbA1c > 8.0%
- History or evidence of chronic kidney disease (serum creatinine > 1.5 mg/dL)
- History of proliferative diabetic retinopathy that has not been treated with laser therapy
- Pregnant or not using acceptable birth control
- Living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example HIV+ or taking immunosuppressive medications for any reason).
- History of autoimmune diseases or diabetes
- History of HIV History of autoimmune disease or type 1 diabetes (use of insulin continuously since diagnosis) in first degree family members
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes Research Center at Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Determination of Dosing and Frequency of BCG Administration Necessary to Alter T-Lymphocyte Profiles in Type I Diabetics
Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the pancreas. The investigators have discovered the specific autoimmune cells responsible for destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means of destroying those cells.
Read the detailed description
The investigators are now aiming to use a similar strategy (vaccination with BCG, the vaccine used world-wide to protect against tuberculosis) in human type 1 diabetes to see if the abnormal immune cells can be depleted. This is the first step in trying to cure established type 1 diabetes.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- BCG, Saline
- Keywords
- type 1 diabetes mellitus, immune modulation, cure, autoimmunity
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCGBiological
BCG vaccination at 0 and 4 weeks
SalineBiological
Saline vaccination at 0 and 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| E | Experimental | BCG vaccination Receives: Biological: BCG |
| P | Placebo comparator | Saline vaccination Receives: Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of autoreactive t-cells
Measured: Measured weekly in first 8 weeks, then every other week for weeks 8-12
Secondary outcomes (1)
Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels
Measured: Weekly for first 8 weeks, then every other week for weeks 8-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2010
- Study completionFeb 2011
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 Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M. Nathan, MD, Massachusetts General Hospital
- Investigators
- David M Nathan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607230
- Sponsor's protocol ID
- 2007p-001347
- Status last verified
- Nov 2013
- First submitted
- 22 Jan 2008
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Faustman DL, Wang L, Okubo Y, Burger D, Ban L, Man G, Zheng H, Schoenfeld D, Pompei R, Avruch J, Nathan DM. Proof-of-concept, randomized, controlled clinical trial of Bacillus-Calmette-Guerin for treatment of long-term type 1 diabetes. PLoS One. 2012;7(8):e41756. doi: 10.1371/journal.pone.0041756. Epub 2012 Aug 8.
PubMed 22905105
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Dosing and Frequency of BCG Administration Necessary to Alter T-Lymphocyte Profiles in Type I Diabetics
- ClinicalTrials.gov ID
- NCT00607230
- Acronym / sponsor ID
- 2007p-001347
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes mellitus, immune modulation, cure, autoimmunity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Feb 2008 (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.
Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the pancreas. The investigators have discovered the specific autoimmune cells responsible for destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means of destroying those cells.
Detailed description
The investigators are now aiming to use a similar strategy (vaccination with BCG, the vaccine used world-wide to protect against tuberculosis) in human type 1 diabetes to see if the abnormal immune cells can be depleted. This is the first step in trying to cure established type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E | Experimental | Biological: BCGBCG vaccination |
| P | Placebo comparator | Biological: SalineSaline vaccination |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Type 1 diabetes treated continuously with insulin from time of diagnosis
- Age 18-55
- Anti-GAD positive
- HIV antibody negative
- Normal CBC
Key exclusion criteria (14 listed)
- History of chronic infectious disease, such as HIV
- History of tuberculosis, TB risk factors, or history of + PPD, or BCG vaccination
- Treatment with glucocorticoids (other than intermittent nasal steroids) or disease or condition likely to require steroid therapy
- Other conditions or treatments associated with increased risk of infections such as patients with previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason
- Current treatment with aspirin > 160 mg/day or chronic, daily NSAIDs
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 |
|---|---|---|
| BCGBCG vaccination at 0 and 4 weeks | Biological | E |
| SalineSaline vaccination at 0 and 4 weeks | Biological | P |
Primary outcome
concentration of autoreactive t-cells
Time frame: Measured weekly in first 8 weeks, then every other week for weeks 8-12
1 secondary outcome
Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels
Time frame: Weekly for first 8 weeks, then every other week for weeks 8-12
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 5 Nov 2013.
- Derived from this study: PubMed 22905105Faustman DL, Wang L, Okubo Y, Burger D, Ban L, Man G, Zheng H, Schoenfeld D, Pompei R, Avruch J, Nathan DM. Proof-of-concept, randomized, controlled clinical trial of Bacillus-Calmette-Guerin for treatment of long-term type 1 diabetes. PLoS One. 2012;7(8):e41756. doi: 10.1371/journal.pone.0041756. Epub 2012 Aug 8.
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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.
David M Nathan, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCG and Saline in people with Type 1 Diabetes Mellitus, run by Massachusetts General Hospital 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 8 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 5 Nov 2013. 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. 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 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?
concentration of autoreactive t-cells (time frame: Measured weekly in first 8 weeks, then every other week for weeks 8-12). 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 NCT00607230, 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 5 Nov 2013.