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Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes (TN-23)

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ClinicalTrials.gov Identifier: NCT03396484
Recruitment Status : Not yet recruiting
First Posted : January 11, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE January 4, 2018
First Posted Date  ICMJE January 11, 2018
Last Update Posted Date May 14, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
DQ8 Antigen Presentation [ Time Frame: 6 months after initiation of treatment ]
insulin peptide-specific DQ8 antigen presentation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03396484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes
Official Title  ICMJE Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes Mellitus
Brief Summary A study is to see if methyldopa can change the immune system's attack on insulin producing cells in people at early stages of type 1 diabetes.
Detailed Description

The study is a randomized, double blinded, placebo-controlled, multi-center crossover clinical trial.

Eligible subjects will be randomized in a 1:1 allocation ratio to one of two treatment schedules: first methyldopa then placebo vs. first placebo then methyldopa.

The study objective is to assess the safety, efficacy, and mode of action of methyldopa to reduce DQ8 antigen presentation in individuals at Stage 1 and 2 of type 1 diabetes (T1D).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Type1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Methyldopa
    Tablet for oral dosing
    Other Name: Aldomet
  • Drug: Placebo
    Tablet for oral dosing
Study Arms  ICMJE
  • Experimental: Methyldopa

    Adults: methyldopa 500mg twice daily for one week and then increased to 500mg three times a day

    Children: methyldopa dose based on weight twice daily for one week then increased to three times a day

    Intervention: Drug: Methyldopa
  • Placebo Comparator: Placebo
    Inactive agent to match active drug in appearance and dose frequency.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant in TrialNet Pathway to Prevention Study (TN01)
  • Willing to provide Informed Consent or, if the subject is <18 years of age, have a parent or legal guardian provide Informed Consent
  • Confirmed positive for one or more autoantibodies, one of which is insulin autoantibody (mIAA)
  • Positive for at least one gene encoding HLA-DQ8 (DQB*0302)
  • If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and during the study
  • Have normal or abnormal glucose tolerance on OGTT performed within 7 weeks of randomization

Exclusion Criteria:

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • History of clinically significant anemia or Hemoglobin <10 g/dl
  • Evidence of liver dysfunction
  • History of renal insufficiency
  • History of symptomatic hypotension including positional hypotension
  • Systolic BP < 100 mmHg for adults or blood pressure < 5th percentile for age/height/gender in children and adolescents
  • Use of a treatment that is known to cause a significant, ongoing change in the course of diabetes or immunologic status, within 4 weeks prior to participation. This includes high-dose inhaled, extensive topical or systemic glucocorticoids
  • Females who are pregnant at the time of screening, breastfeeding or unwilling to defer pregnancy during the 16-month study period. (Female participant must be at least 100 days postpartum before enrollment into study)
  • Unable to avoid concurrent antihypertensive medications, monoamine oxidase (MAO) inhibitors, lithium, or medications containing ferrous sulfate or ferrous gluconate
  • Unable to avoid medications that affect stomach pH, such as proton pump inhibitors or histamine H2 receptor blockers
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Rafkin 305-243-6146 lrafkin@miami.edu
Contact: Ryan O'Donnell 813-396-9551 Ryan.O'Donnell@epi.usf.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03396484
Other Study ID Numbers  ICMJE Methyldopa
UC4DK106993 ( U.S. NIH Grant/Contract )
UC4DK117009 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Carla Greenbaum, MD Type 1 Diabetes TrialNet
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date May 2019

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