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Trial record 1 of 1 for:    NCT00607230
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Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David M. Nathan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00607230
First received: January 22, 2008
Last updated: November 4, 2013
Last verified: November 2013

January 22, 2008
November 4, 2013
November 2007
December 2010   (final data collection date for primary outcome measure)
concentration of autoreactive t-cells [ Time Frame: Measured weekly in first 8 weeks, then every other week for weeks 8-12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00607230 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Biological: BCG
    BCG vaccination at 0 and 4 weeks
  • Biological: Saline
    Saline vaccination at 0 and 4 weeks
  • Experimental: E
    BCG vaccination
    Intervention: Biological: BCG
  • Placebo Comparator: P
    Saline vaccination
    Intervention: Biological: Saline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria (Type 1 diabetic subjects):

  • 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)

Exclusion Criteria Type 1 diabetic subjects):

  • 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
  • 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).

Inclusion Criteria (Control Non-diabetic Subjects):

  • Age 18-45

Exclusion Criteria (Control Non-diabetic Subjects):

  • 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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00607230
2007p-001347
Yes
David M. Nathan, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: David M Nathan, MD Massachusetts General Hospital
Massachusetts General Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP