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NCT00442767 · ClinicalTrials.gov registry record · Phase 4

Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus

A Phase 4 study, sponsored by Montefiore Medical Center.

Completed
Registry status
Phase 4
Development phase
8
Enrollment target

NCT00442767: Completed Phase 4 study, sponsored by Montefiore Medical Center.

NCT00442767 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00442767, a Phase 4 study, has completed, sponsored by Montefiore Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
8 participants
Enrollment target

Study Summary

The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions. The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.

Primary Outcome

Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone

Interventions

  • DRUG Insulin
  • DRUG Pramlintide + Insulin

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2007-02
Est. Completion 2009-02
Phase Phase 4
Montefiore Medical Center

345 total trials

What the finished NCT00442767 record still lists

NCT00442767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

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

NCT00442767 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00442767 about?

NCT00442767 is a clinical study titled "Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus". The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions. The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppre...

What is the current status of trial NCT00442767?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2007-02. Estimated completion is 2009-02.

What interventions are being tested in trial NCT00442767?

The interventions under investigation include: Insulin (DRUG), Pramlintide + Insulin (DRUG).

Who is sponsoring clinical trial NCT00442767?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00442767's enrollment target sits among peer trials

8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00442767, the US trial registry maintained by the National Library of Medicine. NCT00442767 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.