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. |
| NCT02223065 ↗ | Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State | Completed | AstraZeneca | Phase 1 | 2014-09-01 | The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy subjects. |
| NCT02284893 ↗ | Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Contr | Completed | AstraZeneca | Phase 3 | 2014-09-09 | Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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