NCT03396484

Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes

Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes Mellitus

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Methyldopa	Tablet for oral dosing
DRUG	Placebo	Tablet for oral dosing

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2018-01-11
• Last updated: 2020-06-30

Regulatory

• FDA-regulated drug study