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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

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Clinical Trials for Dapagliflozin; Saxagliptin Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT01606007 Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes Completed AstraZeneca Phase 3 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 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 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 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 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 The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy subjects.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Dapagliflozin; Saxagliptin Hydrochloride

Condition Name

Condition Name for Dapagliflozin; Saxagliptin Hydrochloride
Intervention Trials
Type 2 Diabetes Mellitus 8
Type 2 Diabetes 5
Diabetes Mellitus, Type 2 4
Type2 Diabetes Mellitus 3
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Condition MeSH

Condition MeSH for Dapagliflozin; Saxagliptin Hydrochloride
Intervention Trials
Diabetes Mellitus, Type 2 22
Diabetes Mellitus 22
Hypoglycemia 1
Cardiovascular Diseases 1
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Clinical Trial Locations for Dapagliflozin; Saxagliptin Hydrochloride

Trials by Country

Trials by Country for Dapagliflozin; Saxagliptin Hydrochloride
Location Trials
United States 134
Canada 24
Mexico 16
South Africa 8
Poland 7
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Trials by US State

Trials by US State for Dapagliflozin; Saxagliptin Hydrochloride
Location Trials
Texas 10
California 8
Florida 8
Arizona 7
South Carolina 7
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Clinical Trial Progress for Dapagliflozin; Saxagliptin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Dapagliflozin; Saxagliptin Hydrochloride
Clinical Trial Phase Trials
Phase 4 5
Phase 3 10
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Dapagliflozin; Saxagliptin Hydrochloride
Clinical Trial Phase Trials
Completed 8
Not yet recruiting 7
Recruiting 7
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Clinical Trial Sponsors for Dapagliflozin; Saxagliptin Hydrochloride

Sponsor Name

Sponsor Name for Dapagliflozin; Saxagliptin Hydrochloride
Sponsor Trials
AstraZeneca 19
The University of Texas Health Science Center at San Antonio 2
Prof. Dr. Thomas Forst 1
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Sponsor Type

Sponsor Type for Dapagliflozin; Saxagliptin Hydrochloride
Sponsor Trials
Industry 21
Other 16
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Serving hundreds of leading biopharmaceutical companies globally:

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UBS
Accenture
Mallinckrodt
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Express Scripts
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