Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
Public ClinicalTrials.gov record NCT01606007. 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 Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.
Study identification
- NCT ID
- NCT01606007
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,282 participants
Conditions and interventions
Conditions
Interventions
- Saxagliptin Drug
- Metformin XR Drug
- Dapagliflozin Drug
- Placebo matching with Dapagliflozin Drug
- Placebo matching with Saxagliptin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jul 2012 (Type not available)
- Primary completion
- Jan 2014 (Actual)
- Completion
- Jan 2014 (Actual)
- Last update posted
- May 15, 2017
2012 – 2014
United States locations
- U.S. sites
- 80
- U.S. states
- 26
- U.S. cities
- 76
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209 | — |
| Central Alabama Research | Homewood | Alabama | 35244 | — |
| Terence T. Hart, Md | Muscle Shoals | Alabama | 35662 | — |
| International Institute Of Clinical Research | Ozark | Alabama | 36360 | — |
| Clinical Research Advantage | Mesa | Arizona | 85206 | — |
| Elite Clinical Studies, Llc | Phoenix | Arizona | 85018 | — |
| Genova Clinical Research | Tucson | Arizona | 85704 | — |
| Medical Investigations, Inc. | Little Rock | Arkansas | 72205 | — |
| Aureus Research, Inc. | Little Rock | Arkansas | 72211 | — |
| Southland Clinical Research Center, Inc. | Fountain Valley | California | 92708 | — |
| Torrance Clinical Research | Lomita | California | 90717 | — |
| National Research Inst | Los Angeles | California | 90057 | — |
| Providence Clinical Research | North Hollywood | California | 91606 | — |
| Diabetes Medical Center Of California | Northridge | California | 91325 | — |
| Mehrdad Kevin Ariani Md, Inc. | Northridge | California | 91325 | — |
| Lucita M. Cruz,Md.,Inc. | Norwalk | California | 90650 | — |
| Center For Clinical Trials, Llc. | Paramount | California | 90723 | — |
| Center For Clinical Trials Of Sacramento, Inc. | Sacramento | California | 95823 | — |
| Trinitas Research, Inc | San Jose | California | 95116 | — |
| Orange County Research Center | Tustin | California | 92780 | — |
| Clinical Research Advantage | Colorado Springs | Colorado | 80906 | — |
| Infocus Clinical Research | Denver | Colorado | 80211 | — |
| Lynn Institute Of Denver | Denver | Colorado | 80246 | — |
| Southeast Clinical Research, Llc | Chiefland | Florida | 32626 | — |
| Clinical Therapeutics Corporation | Coral Gables | Florida | 33134 | — |
| Southeast Clinical Research, Llc | Jacksonville | Florida | 32216 | — |
| Fpa Clinical Research | Kissimmee | Florida | 34741 | — |
| Clinical Research Of Miami, Inc. | Miami | Florida | 33126 | — |
| Advanced Pharma Cr, Llc | Miami | Florida | 33136 | — |
| Newphase Clinical Trials, Inc. | Miami Beach | Florida | 33140 | — |
| Omega Research Consultants, Llc | Orlando | Florida | 32804 | — |
| Palm Harbor Medical Associates | Palm Harbor | Florida | 34684 | — |
| Andres Patron, Do Pa | Pembroke Pines | Florida | 33026 | — |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | — |
| Cedar Crosse Research Center | Chicago | Illinois | 60607-4559 | — |
| Deerbrook Medical Associates | Vernon Hills | Illinois | 60061 | — |
| Clinical Research Advantage | Council Bluffs | Iowa | 51503 | — |
| Horizon Research Group Of Opelousas, Llc | Eunice | Louisiana | 70535 | — |
| Associated Internal Medicine Specialists | Battle Creek | Michigan | 49015 | — |
| Harris And Associates, P.C. | Detroit | Michigan | 48235 | — |
| Patterson Medical Clinic | Florissant | Missouri | 63031 | — |
| Bellevue Family Practice | Bellevue | Nebraska | 68005 | — |
| Clinical Research Advantage | Elkhorn | Nebraska | 68022 | — |
| Clinical Research Advantage | Fremont | Nebraska | 68025 | — |
| Clinical Research Advantage | Omaha | Nebraska | 68130 | — |
| South Jersey Medical Associates, P.A. | Blackwood | New Jersey | 08012 | — |
| Central Jersey Health And Medical Research | Elizabeth | New Jersey | 07205 | — |
| Southgate Medical Group | West Seneca | New York | 14224 | — |
| Metrolina Internal Medicine | Charlotte | North Carolina | 28204 | — |
| Triad Clinical Trials, Llc | Greensboro | North Carolina | 27410 | — |
| Diabetes & Endocrinology Consultants | Morehead City | North Carolina | 28557 | — |
| Pmg Research Of Winston-Salem, Llc | Winston-Salem | North Carolina | 27103 | — |
| Daystar Clinical Resarch, Inc. | Akron | Ohio | 44313 | — |
| Sterling Research Grp, Ltd. | Cincinnati | Ohio | 45246 | — |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | — |
| Primed Clinical Research | Dayton | Ohio | 45419 | — |
| Physicians Research, Inc. | Zanesville | Ohio | 43701 | — |
| Lynn Institute Of Norman | Norman | Oklahoma | 73069 | — |
| Willamette Valley Clinical Studies | Eugene | Oregon | 97404 | — |
| Oregon Clinical Research | Portland | Oregon | 97220 | — |
| Heritage Valley Medical Group | Beaver | Pennsylvania | 15009 | — |
| Wellmon Family Practice | Shippensburg | Pennsylvania | 17257 | — |
| Tlm Medical Services | Columbia | South Carolina | 29204 | — |
| Palmetto Clinical Trial Services Llc | Fountain Inn | South Carolina | 29644 | — |
| Holston Medical Group | Bristol | Tennessee | 37620 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Pmg Research Of Knoxville | Knoxville | Tennessee | 37912 | — |
| Arlington Family Research Center, Inc. | Arlington | Texas | 76012 | — |
| Padre Coast Clinical Research | Corpus Christi | Texas | 78404 | — |
| Dallas Diabetes & Endocrine Center | Dallas | Texas | 75230-2548 | — |
| Excel Clinical Research, Llc | Houston | Texas | 77035 | — |
| North Hills Medical Research, Inc. | North Richland Hills | Texas | 76180 | — |
| Med-Olam Clinical Research | Pasadena | Texas | 77504 | — |
| Sam Clinical Research Center | San Antoinio | Texas | 78229 | — |
| Covenant Clinical Research, Pa | San Antonio | Texas | 78229 | — |
| Hillcrest Family Health Center | Waco | Texas | 76710 | — |
| Val R. Hansen, M.D. | Bountiful | Utah | 84010 | — |
| Highland Clinical Research | Salt Lake City | Utah | 84124 | — |
| Southwestern Vermont Med Cntr | Bennington | Vermont | 05201 | — |
| Hampton Roads Center For Clinical Research, Inc. | Suffolk | Virginia | 23435 | — |
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 NCT01606007, 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 15, 2017 · Synced Oct 17, 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 NCT01606007 live on ClinicalTrials.gov.