- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03396484
Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes (TN-23)
Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 |
Tablet for oral dosing
Other Names:
|
Placebo Comparator: Placebo
Inactive agent to match active drug in appearance and dose frequency.
|
Tablet for oral dosing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DQ8 Antigen Presentation
Time Frame: 6 months after initiation of treatment
|
insulin peptide-specific DQ8 antigen presentation
|
6 months after initiation of treatment
|
Collaborators and Investigators
Investigators
- Study Chair: Carla Greenbaum, MD, Type 1 Diabetes TrialNet
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympatholytics
- Methyldopa
Other Study ID Numbers
- Methyldopa
- UC4DK117009 (U.S. NIH Grant/Contract)
- UC4DK106993 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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