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.
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.
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.
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
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.
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