NCT00607230

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

3.1 years

First QC Date

January 22, 2008

Last Update Submit

November 4, 2013

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitusimmune modulationcureautoimmunity

Outcome Measures

Primary Outcomes (1)

  • concentration of autoreactive t-cells

    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

    Weekly for first 8 weeks, then every other week for weeks 8-12

Study Arms (2)

E

EXPERIMENTAL

BCG vaccination

Biological: BCG

P

PLACEBO COMPARATOR

Saline vaccination

Biological: Saline

Interventions

BCGBIOLOGICAL

BCG vaccination at 0 and 4 weeks

E
SalineBIOLOGICAL

Saline vaccination at 0 and 4 weeks

P

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).
  • Age 18-45
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Center at Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 22905105DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Autoimmune Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • David M Nathan, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Diabetes Center

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

US(1)