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NCT00108004 · ClinicalTrials.gov registry record · Phase 3

Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
400
Enrollment target

NCT00108004: Completed Phase 3 study, sponsored by AstraZeneca.

NCT00108004 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00108004, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
400 participants
Enrollment target

Study Summary

This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Primary Outcome

To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.

Interventions

  • DRUG pramlintide acetate

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2003-04
Est. Completion 2005-06
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT00108004 record still lists

NCT00108004 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 1 intervention - of which pramlintide acetate is the first listed.

NCT00108004 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00108004 about?

NCT00108004 is a clinical study titled "Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus". This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

What is the current status of trial NCT00108004?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2003-04. Estimated completion is 2005-06.

What interventions are being tested in trial NCT00108004?

The interventions under investigation include: pramlintide acetate (DRUG).

Who is sponsoring clinical trial NCT00108004?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00108004's enrollment target sits among peer trials

400 922nd of 2000 higher than 1,039 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00108004, the US trial registry maintained by the National Library of Medicine. NCT00108004 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.