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NCT00042458 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

A Phase 3 study of Diabetes Mellitus, Type 1, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
296
Enrollment target
20
Study locations

NCT00042458 is a Phase 3 study of Diabetes Mellitus, Type 1 that has completed, run by AstraZeneca. The registered enrollment target is 296 participants, below the 1,264-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT00042458, a Phase 3 study of Diabetes Mellitus, Type 1, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
296 participants
Enrollment target
20
Study locations

Study Summary

This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.

Conditions Studied

Diabetes Mellitus, Type 1

Interventions

  • DRUG Placebo
  • DRUG Pramlintide acetate

Study Locations (20)

California

  • East Bay Clinical Trial Center - Concord
  • Valley Research - Fresno
  • UCSD Diabetes Research Center - San Diego
  • Diabetes Research Institute - San Mateo
  • Sansum Medical Research Institute - Santa Barbara
  • Diablo Clinical Research - Walnut Creek

Florida

  • Medical Research Unlimited - Aventura
  • Medical Research Unlimited - Aventura
  • Internal Medicine Associates - Fort Myers
  • Suncoast Clinical Research - New Port Richey
  • Children's Clinic - Tallahassee

Arizona

  • Ana Ventures LLC - Mesa
  • Phoenix Endocrinology Clinic, Ltd. - Phoenix

Illinois

  • St. James Diabetes Center - Chicago Heights
  • St. James Diabetes Center - Chicago Heights

Colorado

  • Barbara Davis Center for Childhood Diabetes - Denver

District of Columbia

  • MedStar Clinical Research Center - Washington D.C.

Georgia

  • Atlanta Diabetes Associates - Atlanta

Indiana

  • Indiana University Outpatient Clinical Research - Indianapolis

Trial Details

FieldValue
Enrollment Target 296 participants
Start Date 2002-04
Est. Completion 2003-03
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00042458

The ClinicalTrials.gov registry entry for NCT00042458 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,264-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (77% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00042458 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT00042458 about?

NCT00042458 is a clinical study titled "Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control". This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.

What is the current status of trial NCT00042458?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2002-04. Estimated completion is 2003-03.

What conditions does trial NCT00042458 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.

What interventions are being tested in trial NCT00042458?

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

Who is sponsoring clinical trial NCT00042458?

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

Where is trial NCT00042458 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.