Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
Public ClinicalTrials.gov record NCT00885378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.
Study identification
- NCT ID
- NCT00885378
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 166 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 78 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2009
- Primary completion
- Jan 31, 2010
- Completion
- Jan 31, 2010
- Last update posted
- May 31, 2015
2009 – 2010
United States locations
- U.S. sites
- 25
- U.S. states
- 13
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | — |
| Southland Clinical Research Center, Inc. | Fountain Valley | California | 92708 | — |
| Torrance Clinical Research | Lomita | California | 90717 | — |
| Ritchken & First M.D.'S | San Diego | California | 92117 | — |
| Central Florida Clinical Trials, Inc. | Altamonte Springs | Florida | 32701 | — |
| Family Care Associates Of Nw Florida | Chipley | Florida | 32428 | — |
| Clinical Therapeutics Corporation | Coral Gables | Florida | 33134 | — |
| Nextphase Clinical Trials, Inc. | Miami | Florida | 33145 | — |
| Middle Georgia Drug Study Center, Llc | Perry | Georgia | 31069 | — |
| Louisiana Heart Center Research | Slidell | Louisiana | 70458 | — |
| Jackson Clinic | Rolling Fork | Mississippi | 39159 | — |
| Community Health Care Of Manchester | Akron | Ohio | 44319 | — |
| Midwest Regional Research, Inc. | Bellbrook | Ohio | 45305 | — |
| Wells Institute For Health Awareness | Kettering | Ohio | 45429 | — |
| Newark Physician Associates | Newark | Ohio | 43055 | — |
| Integris Family Care South | Oklahoma City | Oklahoma | 73170 | — |
| Integris Family Care Yukon | Yukon | Oklahoma | 73099 | — |
| Williamette Valley Clinical Studies | Eugene | Oregon | 97404 | — |
| Integrated Medical Group Pc/Fleetwood Clinical Research | Fleetwood | Pennsylvania | 19522 | — |
| Southeastern Research Associates, Inc | Taylors | South Carolina | 29687 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Village Family Practice | Houston | Texas | 77024 | — |
| Southwest Clinical Research Centers, Llc | Pearland | Texas | 77584 | — |
| Jolene K. Berg, Md., Dgd Research, Inc. | San Antonio | Texas | 78229 | — |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23454 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00885378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 31, 2015 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00885378 live on ClinicalTrials.gov.