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NCT00757588 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
A Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
- 20
- Study locations
NCT00757588: Completed Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.
NCT00757588 is a Phase 3 study of Type 2 Diabetes that has completed, run by AstraZeneca. The registered enrollment target is 455 participants, below the 3,922-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00757588, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.
Primary Outcome
Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use
Conditions Studied
Interventions
- DRUG Saxagliptin, 5 mg + insulin
- DRUG Placebo + insulin
Study Locations (20)
California
- Valley Research - Fresno
- Torrance-Lomita Medical Center - Lomita
- Diabetes Medical Center Of California - Northridge
- Ritchken & First M.D.'S - San Diego
- Encompass Clinical Research - Spring Valley
Florida
- Central Florida Clinical Trials, Inc. - Altamonte Springs
- Family Care Associates Of Nw Florida - Chipley
- Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc. - Marianna
Texas
- Texas Center For Drug Development - Houston
- Dgd Research, Inc. - San Antonio
Arizona
- Clinical Research Advantage, Inc - Tempe
Georgia
- Endocrine Research Solutions, Inc. - Roswell
Mississippi
- Danny W. Jackson P.A. - Rolling Fork
New York
- Southgate Medical Group - West Seneca
South Carolina
- Southeastern Research Associates, Inc. - Taylors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2008-11 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
What the finished NCT00757588 record still lists
NCT00757588 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, below the 3,922-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Saxagliptin, 5 mg + insulin is the first listed.
NCT00757588 names 20 study sites across 13 states, led by California, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT00757588 about?
NCT00757588 is a clinical study titled "Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin". The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.
What is the current status of trial NCT00757588?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2008-11. Estimated completion is 2010-04.
What conditions does trial NCT00757588 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT00757588?
The interventions under investigation include: Saxagliptin, 5 mg + insulin (DRUG), Placebo + insulin (DRUG).
Who is sponsoring clinical trial NCT00757588?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00757588 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes
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 NCT00757588's enrollment target sits among peer trials
455 48th of 327 higher than 280 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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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