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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02580877
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Type 1 Diabetes TrialNet
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: 67.5 mg oral insulin crystals daily Drug: 500mg oral insulin crystals every other week Phase 2

Detailed Description:
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. .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1
Study Start Date : January 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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
Drug: 67.5 mg oral insulin crystals daily
human insulin crystals in capsules
Other Name: Humulin R crystals

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
Drug: 500mg oral insulin crystals every other week
human insulin crystals in capsules
Other Name: Humulin R crystals




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580877


Locations
Show Show 19 study locations
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type 1 Diabetes TrialNet
Investigators
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Study Chair: Carla Greenbaum, MD Type 1 Diabetes TrialNet
Publications:
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT02580877    
Other Study ID Numbers: Oral Insulin-TN20
UC4DK106993 ( U.S. NIH Grant/Contract )
UC4DK117009 ( U.S. NIH Grant/Contract )
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
oral insulin
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Methamphetamine
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors