Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Determination of Dosing and Frequency of BCG Administration Necessary to Alter T-Lymphocyte Profiles in Type I Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607230
• Other study ID #: 2007p-001347
• Status: Completed
• Phase: Phase 1
• First received: January 22, 2008
• Last updated: November 4, 2013
• Start date: November 2007
• Est. completion date: February 2011

Study information

• Verified date: November 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Biological:
• BCG
BCG vaccination at 0 and 4 weeks
• Saline
Saline vaccination at 0 and 4 weeks

Locations

Country	Name	City	State
United States	Diabetes Research Center at Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of autoreactive t-cells		Measured weekly in first 8 weeks, then every other week for weeks 8-12	No
Secondary	Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels		Weekly for first 8 weeks, then every other week for weeks 8-12	No