Status:
COMPLETED
A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40-79 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.
Detailed Description
This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients w...
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment
- 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
- Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
- Past or current history of severe diabetic complications
- Patients requiring insulin therapy
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01512849
Start Date
January 1 2012
End Date
September 1 2012
Last Update
January 8 2026
Active Locations (1)
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1
Reserch site
Kanto, Japan