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COMPLETED Phase 3

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

NCT00042458 · View on ClinicalTrials.gov ↗

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

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

1,053 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00042458 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00042458?

The interventions under investigation include: Placebo (DRUG), Pramlintide acetate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00042458?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial