CLINICAL TRIALS PROFILE FOR DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
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All Clinical Trials for dapagliflozin; saxagliptin hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01606007 ↗ | Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes | Completed | AstraZeneca | Phase 3 | 2012-07-01 | 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. |
| NCT01619059 ↗ | Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes | Completed | AstraZeneca | Phase 3 | 2012-06-01 | 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. |
| NCT01646320 ↗ | Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes | Completed | AstraZeneca | Phase 3 | 2012-09-01 | The purpose of this study is to learn if BMS-512148 (Dapagliflozin) 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. |
| NCT01662999 ↗ | Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants | Completed | AstraZeneca | Phase 1 | 2012-08-01 | The purpose of this study is to evaluate whether the pharmacokinetics (body concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when they are administered together |
| NCT02060201 ↗ | Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC) | Completed | AstraZeneca | Phase 1 | 2014-02-01 | The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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