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NCT00505375 · ClinicalTrials.gov registry record · Phase 2

Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus

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

Completed
Registry status
Phase 2
Development phase
112
Enrollment target

NCT00505375: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00505375 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00505375, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 2
Development phase
112 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in individuals with new onset T1DM will improve insulin secretion (C-peptide production) compared to placebo.

Primary Outcome

The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.

Interventions

  • OTHER Placebo
  • DRUG CTLA-4 Ig

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2008-02
Est. Completion 2012-05
Phase Phase 2

What the finished NCT00505375 record still lists

NCT00505375 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).

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

NCT00505375 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00505375 about?

NCT00505375 is a clinical study titled "Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus". The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in individuals with new onset T1DM will improve insulin secretion (C-peptide production) compared to placebo.

What is the current status of trial NCT00505375?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2008-02. Estimated completion is 2012-05.

What interventions are being tested in trial NCT00505375?

The interventions under investigation include: Placebo (OTHER), CTLA-4 Ig (DRUG).

Who is sponsoring clinical trial NCT00505375?

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 NCT00505375's enrollment target sits among peer trials

112 631st of 2000 higher than 1,369 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 NCT00505375, the US trial registry maintained by the National Library of Medicine. NCT00505375 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.