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NCT00918138 · ClinicalTrials.gov registry record · Phase 3
Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg
A Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
- 20
- Study locations
NCT00918138: Completed Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.
NCT00918138 is a Phase 3 study of Type 2 Diabetes that has completed, run by AstraZeneca. The registered enrollment target is 219 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00918138, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.
Primary Outcome
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24
Conditions Studied
Interventions
- DRUG Saxagliptin
- DRUG Metformin XR
- DRUG Placebo matching Metformin XR
- DRUG Placebo matching Saxagliptin
Study Locations (20)
Other
- Local Institution - Beersheba
- Local Institution - Holon
- Local Institution - Kfar Saba
- Local Institution - Safed
Florida
- Clinical Research Of South Florida - Coral Gables
- Palm Springs Research Institute - Hialeah
- Healthcare Clinical Data, Inc. - North Miami
California
- Pacific Sleep Medicine Services (Avastra Clinical Trials) - Redlands
- Orange County Research Center - Tustin
Buenos Aires
- Local Institution - Buenos Aires
- Local Institution - Capital Federal
Durango
- Local Institution - Durango
- Local Institution - Durango
Arizona
- Dedicated Phase I, Inc. - Phoenix
Georgia
- River Birch Research Alliance, Llc - Blue Ridge
Michigan
- Jasper Clinic, Inc. - Kalamazoo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
What the finished NCT00918138 record still lists
NCT00918138 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 4 interventions - of which Saxagliptin is the first listed.
NCT00918138 names 20 study sites across 12 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT00918138 about?
NCT00918138 is a clinical study titled "Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg". The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.
What is the current status of trial NCT00918138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2009-08. Estimated completion is 2010-05.
What conditions does trial NCT00918138 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT00918138?
The interventions under investigation include: Saxagliptin (DRUG), Metformin XR (DRUG), Placebo matching Metformin XR (DRUG), Placebo matching Saxagliptin (DRUG).
Who is sponsoring clinical trial NCT00918138?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00918138 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Michigan. 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 NCT00918138's enrollment target sits among peer trials
219 90th of 327 higher than 238 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.
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