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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: Completed Phase 3 study of Diabetes Mellitus, Type 1, sponsored by AstraZeneca.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2002-04 |
| Est. Completion | 2003-03 |
| Phase | Phase 3 |
What the finished NCT00042458 record still lists
NCT00042458 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, below the 1,264-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (77% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00042458's enrollment target sits among peer trials
296 25th of 118 higher than 94 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 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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