Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
Public ClinicalTrials.gov record NCT00859898. 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, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study
Study identification
- NCT ID
- NCT00859898
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,093 participants
Conditions and interventions
Conditions
Interventions
- Dapagliflozin Drug
- Metformin XR Drug
- dapagliflozin matching Placebo Drug
- metformin HCl Modified Release matching Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 77 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 2009 (Type not available)
- Primary completion
- May 2010 (Actual)
- Completion
- May 2010 (Actual)
- Last update posted
- Jul 7, 2016
2009 – 2010
United States locations
- U.S. sites
- 64
- U.S. states
- 24
- U.S. cities
- 56
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| International Institute Of Clinical Research | Ozark | Alabama | 36360 | — |
| Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc | Tempe | Arizona | 85282 | — |
| Clinical Research Advantage, Inc. | Tempe | Arizona | 85282 | — |
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | — |
| Encompass Clinical Research-North Coast | Encinitas | California | 92024 | — |
| Southland Clinical Research Center, Inc. | Fountain Valley | California | 92708 | — |
| Valley Research | Fresno | California | 93720 | — |
| Del Rosario Medical Clinic, Inc. | Huntington Park | California | 90255 | — |
| Irvine Center For Clinical Research, Inc. | Irvine | California | 92618 | — |
| Pacific Sleep Medicine Services (Avastra Clinical Trials) | Redlands | California | 92373 | — |
| Orange County Research Center | Tustin | California | 92780 | — |
| Lynn Institute Of The Rockies | Colorado Springs | Colorado | 80907 | — |
| Radiant Research, Inc. | Denver | Colorado | 80239 | — |
| Clinical Therapeutics Corporation | Coral Gables | Florida | 33134 | — |
| Nextphase Clinical Trials, Inc. | Miami | Florida | 33145 | — |
| Baptist Diabetes Associates | Miami | Florida | 33156 | — |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | — |
| Lake Hartwell Family Medicine | Hartwell | Georgia | 30643 | — |
| Middle Georgia Drug Study Center, Llc | Perry | Georgia | 31069 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| Provident Clinical Research | Addison | Illinois | 60101 | — |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | — |
| Deerbrook Medical Associates | Vernon Hills | Illinois | 60061 | — |
| Physicians Research Group | Indianapolis | Indiana | 46250 | — |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | — |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | — |
| Clinilabs, Inc. | New York | New York | 10019 | — |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | — |
| Pharmquest | Greensboro | North Carolina | 27408 | — |
| Crescent Medical Research | Salisbury | North Carolina | 28144 | — |
| Community Health Care, Inc. | Canal Fulton | Ohio | 44614 | — |
| Holzer Clinic, Inc | Gallipolis | Ohio | 45631 | — |
| Wells Institute For Health Awareness | Kettering | Ohio | 45429 | — |
| Newark Physician Associates | Newark | Ohio | 43055 | — |
| Daniel G. Williams, Md | Perrysburg | Ohio | 43551 | — |
| Physician Research, Inc. | Zanesville | Ohio | 43701 | — |
| Gilbert Medical Research, Llc | Bethany | Oklahoma | 73008 | — |
| Tulsa Clinical Research, Llc | Tulsa | Oklahoma | 74104 | — |
| Integris Family Care Yukon | Yukon | Oklahoma | 73099 | — |
| Williamette Valley Clinical Studies | Eugene | Oregon | 97404 | — |
| Dingmans Medical | Dingmans Ferry | Pennsylvania | 18328 | — |
| Integrated Medical Group Pc/Fleetwood Clinical Research | Fleetwood | Pennsylvania | 19522 | — |
| Wellmon Family Practice | Shippensburg | Pennsylvania | 17257 | — |
| Safe Harbor Clinical Research | East Providence | Rhode Island | 02914 | — |
| Southeastern Research Associates, Inc. | Greenville | South Carolina | 29605 | — |
| Holston Medical Group | Bristol | Tennessee | 37620 | — |
| Parkway Medical Group | Fayetteville | Tennessee | 37334 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Southwind Medical Specialists | Memphis | Tennessee | 38125 | — |
| Dallas Diabetes & Endocrine Center | Dallas | Texas | 75230 | — |
| Endocrine Associates | Houston | Texas | 77004 | — |
| Village Family Practice | Houston | Texas | 77024 | — |
| Juno Research, Llc. | Houston | Texas | 77036 | — |
| Non-Invasive Cardiovascular, Pa | Houston | Texas | 77074 | — |
| Excel Clinical Research | Houston | Texas | 77081 | — |
| Texas Center For Drug Development | Houston | Texas | 77081 | — |
| Midland Clinical Research Center | Midland | Texas | 79707 | — |
| Hill Country Medical Associates | New Braunfels | Texas | 78130 | — |
| Covenant Clinical Research, Pa | San Antonio | Texas | 78229 | — |
| S.A.M. Clinical Research Center | San Antonio | Texas | 78229 | — |
| Avastra Clinical Trials | Midvale | Utah | 84047 | — |
| Seven Corners Medical Center | Falls Church | Virginia | 22044 | — |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23454 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
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 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00859898, 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 Jul 7, 2016 · Synced Oct 18, 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 public registry record, listed eligibility criteria, and available contact information for NCT00859898 live on ClinicalTrials.gov.