Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes
Public ClinicalTrials.gov record NCT01619059. 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 Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added to Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Dapagliflozin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
Study identification
- NCT ID
- NCT01619059
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 315 participants
Conditions and interventions
Conditions
Interventions
- Saxagliptin Drug
- Dapagliflozin Drug
- Metformin IR 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
- May 31, 2012
- Primary completion
- May 31, 2014
- Completion
- Dec 31, 2014
- Last update posted
- Apr 21, 2016
2012 – 2015
United States locations
- U.S. sites
- 34
- U.S. states
- 15
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294 | — |
| Terence T. Hart, Md | Muscle Shoals | Alabama | 35662 | — |
| Mesa Family Medical Center | Mesa | Arizona | 85203 | — |
| Clinical Research Advantage Inc/Desert Clinical Research Llc | Mesa | Arizona | 85213 | — |
| Clinical Research Advantage, Inc | Phoenix | Arizona | 85020 | — |
| Clinical Research Advantage, Inc./ Stonecreek Medical Associates, Pc | Phoenix | Arizona | 85028 | — |
| Beach Physicians Clinical Research Corp. | Huntington Beach | California | 92647 | — |
| Torrance Clinical Research | Lomita | California | 90717 | — |
| Randall G. Shue, Do, Inc. | Los Angeles | California | 90023 | — |
| National Research Institute | Los Angeles | California | 90057 | — |
| Cassidy Medical Group/Clinical Research Advantage | Vista | California | 92083 | — |
| Infosphere Clinical Research, Inc. | West Hills | California | 91307 | — |
| New West Physicians, Pc | Golden | Colorado | 80401 | — |
| Southeast Clinical Research, Llc | Chiefland | Florida | 32626 | — |
| Clinical Therapeutics Corporation | Coral Gables | Florida | 33134 | — |
| Medical Research Unlimited, Llc | Hialeah | Florida | 33012 | — |
| University Of Florida Endocrinology & Diabetes | Jacksonville | Florida | 32207 | — |
| Care Partners Clinical Research, Llc | Jacksonville | Florida | 32277 | — |
| Clinical Research Of Miami, Inc. | Miami | Florida | 33126 | — |
| Clinical Research Advantage, Inc. | Evansville | Indiana | 47725 | — |
| Clinical Research Advantage | Evansville | Indiana | 7714 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| Clinical Research Advantage, Inc. | Las Vegas | Nevada | 89128 | — |
| Joslin Diabetes Center Affiliate Of Snhmc | Nashua | New Hampshire | 03063 | — |
| N. Shore Diabetes & Endoc Assoc | New Hyde Park | New York | 11042 | — |
| Digiovanna Institute For Medical Education & Research | North Massapequa | New York | 11758 | — |
| Barat Research Group, Inc. | Charlotte | North Carolina | 28262 | — |
| Sterling Research Grp, Ltd. | Cincinnati | Ohio | 45219 | — |
| Physicians Research, Inc. | Zanesville | Ohio | 43701 | — |
| Tlm Medical Services | Columbia | South Carolina | 29204 | — |
| Family Medicine Of Sayebrook | Myrtle Beach | South Carolina | 29588 | — |
| Holston Medical Group | Bristol | Tennessee | 37620 | — |
| Vanderbilt Diabetes Center | Nashville | Tennessee | 37232 | — |
| Padre Coast Clinical Research | Corpus Christi | Texas | 78404 | — |
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 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01619059, 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 Apr 21, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01619059 live on ClinicalTrials.gov.