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NCT01619059 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes
A Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 315
- Enrollment target
- 20
- Study locations
NCT01619059: Completed Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.
NCT01619059 is a Phase 3 study of Type 2 Diabetes that has completed, run by AstraZeneca. The registered enrollment target is 315 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01619059, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 315 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.
Conditions Studied
Interventions
- DRUG Dapagliflozin
- DRUG Saxagliptin
- DRUG Metformin IR
- DRUG Placebo matching with Saxagliptin
Study Locations (20)
California
- Beach Physicians Clinical Research Corp. - Huntington Beach
- Torrance Clinical Research - Lomita
- Randall G. Shue, Do, Inc. - Los Angeles
- National Research Institute - Los Angeles
- Cassidy Medical Group/Clinical Research Advantage - Vista
- Infosphere Clinical Research, Inc. - West Hills
Florida
- Southeast Clinical Research, Llc - Chiefland
- Clinical Therapeutics Corporation - Coral Gables
- Medical Research Unlimited, Llc - Hialeah
- University Of Florida Endocrinology & Diabetes - Jacksonville
- Care Partners Clinical Research, Llc - Jacksonville
- Clinical Research Of Miami, Inc. - Miami
Arizona
- Mesa Family Medical Center - Mesa
- Clinical Research Advantage Inc/Desert Clinical Research Llc - Mesa
- Clinical Research Advantage, Inc - Phoenix
- Clinical Research Advantage, Inc./ Stonecreek Medical Associates, Pc - Phoenix
Alabama
- University Of Alabama At Birmingham - Birmingham
- Terence T. Hart, Md - Muscle Shoals
Colorado
- New West Physicians, Pc - Golden
Indiana
- Clinical Research Advantage, Inc. - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
What the finished NCT01619059 record still lists
NCT01619059 is an interventional study that assigns participants to a tested intervention. The registered 315 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 (92% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 4 interventions - of which Dapagliflozin is the first listed.
NCT01619059 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01619059 about?
NCT01619059 is a clinical study titled "Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes". 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 studi...
What is the current status of trial NCT01619059?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2012-06. Estimated completion is 2015-01.
What conditions does trial NCT01619059 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT01619059?
The interventions under investigation include: Dapagliflozin (DRUG), Saxagliptin (DRUG), Metformin IR (DRUG), Placebo matching with Saxagliptin (DRUG).
Who is sponsoring clinical trial NCT01619059?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01619059 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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 NCT01619059's enrollment target sits among peer trials
315 65th of 327 higher than 263 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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