A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
NCT ID: NCT01512849
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2012-01-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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TA-7284 Low
TA-7284 Low
Low
TA-7284 High
TA-7284 High
High
Interventions
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TA-7284 Low
Low
TA-7284 High
High
Eligibility Criteria
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Inclusion Criteria
* Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening
* HbA1c of ≥6.5% and ≤10.5% at screening
Exclusion Criteria
* Past or current history of severe diabetic complications
* Patients requiring insulin therapy
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
40 Years
79 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Nobuya Inagaki, MD
Role: STUDY_DIRECTOR
Kyoto University, Graduate School of Medicine
Kazuoki Kondo, MD
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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Reserch site
Kanto, , Japan
Countries
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References
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Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Other Identifiers
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TA-7284-07
Identifier Type: -
Identifier Source: org_study_id
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