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Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Type 1 Diabetes TrialNet
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT02580877
First received: September 30, 2015
Last updated: March 2, 2017
Last verified: March 2017
September 30, 2015
March 2, 2017
January 2016
September 2017   (Final data collection date for primary outcome measure)
Change in Immune Function [ Time Frame: 13 and 26 weeks after first dose versus baseline ]
Assessed by level or quality of T-lymphocyte or autoantibody biomarkers of beta cell specific immune response as measured by change in: CD4 auto-antigen specific ELISPOTs for IFN-g and IL-17, and cD8 peptide-HLA multimers (Q-dots).
Same as current
Complete list of historical versions of study NCT02580877 on ClinicalTrials.gov Archive Site
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Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1
The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).
A minimum of 40 eligible participants will be identified for study participation from the TrialNet Pathway to Prevention study. Participants must have a relative with type 1 diabetes and be positive for insulin autoantibodies and at least one other autoantibody. All participants will receive active treatment of recombinant insulin treatment in capsules of either 67.5 mg daily or 500mg every other week. Participants will need to visit the study site up to eleven times over one year for blood tests and other study procedures. During the beginning treatment phase there are two visits one month apart for those given the 67.5 mg dose, and three visits two weeks apart to titrate the dose for those in the 500mg treatment group. There are three additional treatment visits at months 2, 3, and 6 and 4 additional visits for follow-up at months 7, 8, 9 and 12. The primary outcome is the change in immune function as assessed by change in level or quality of T lymphocyte or autoantibody biomarkers measured between 13 and 26 weeks compared to baseline. .
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Type 1 Diabetes
  • Drug: 67.5 mg oral insulin crystals daily
    human insulin crystals in capsules
    Other Name: Humulin R crystals
  • Drug: 500mg oral insulin crystals every other week
    human insulin crystals in capsules
    Other Name: Humulin R crystals
  • Experimental: 67.5 mg oral insulin crystals daily
    67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
    Intervention: Drug: 67.5 mg oral insulin crystals daily
  • Experimental: 500mg oral insulin crystals every other week
    500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
    Intervention: Drug: 500mg oral insulin crystals every other week

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
92
December 2017
September 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is relative of proband with type 1 diabetes
  • Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7 with an abnormal OGTT
  • Confirmed positive for insulin autoantibodies within previous six months
  • Confirmed positive for one or more other autoantibodies on two separate occasions within the past six months

Exclusion Criteria:

  • Diagnosed with type 1 diabetes
  • History of treatment with insulin or oral hypoglycemic agent
  • History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months
  • Ongoing use of medications known to influence glucose tolerance
  • Pregnant or intending to become pregnant while on study or lactating
Sexes Eligible for Study: All
3 Years to 45 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Italy,   United States
 
 
NCT02580877
Oral Insulin-TN20
Yes
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type 1 Diabetes TrialNet
Study Chair: Carla Greenbaum, MD Type 1 Diabetes TrialNet
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2017

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