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NCT03428945 · ClinicalTrials.gov registry record · Phase 2

Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Terminated
Registry status
Phase 2
Development phase
273
Enrollment target

NCT03428945: Clinical Trial Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT03428945 is a Phase 2 study that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 273 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03428945, a Phase 2 study, was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

TERMINATED
Registry status
Phase 2
Development phase
273 participants
Enrollment target

Study Summary

The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.

Primary Outcome

The primary outcome is the time in months from random treatment assignment to the development of confirmed abnormal glucose tolerance or clinical diabetes.

Interventions

  • DRUG Placebo
  • DRUG Hydroxychloroquine

Trial Details

FieldValue
Enrollment Target 273 participants
Start Date 2018-08-15
Est. Completion 2022-10-31
Phase Phase 2

Why NCT03428945 stopped before completion

NCT03428945 is an interventional study that assigns participants to a tested intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (105% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03428945 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03428945 about?

NCT03428945 is a clinical study titled "Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus". The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.

What is the current status of trial NCT03428945?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 273 participants. The study started on 2018-08-15. Estimated completion is 2022-10-31.

What interventions are being tested in trial NCT03428945?

The interventions under investigation include: Placebo (DRUG), Hydroxychloroquine (DRUG).

Who is sponsoring clinical trial NCT03428945?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03428945's enrollment target sits among peer trials

273 204th of 2000 higher than 1,797 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03428945, the US trial registry maintained by the National Library of Medicine. NCT03428945 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.