Status:
COMPLETED
A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus
Eligibility Criteria
Inclusion
- Established diagnosis of type 2 diabetes mellitus
- Fasting serum C-peptide level \> 0.6 ng/mL
- HbA1c between 7.0 and 10.0%
- Body Mass Index between 20 and 45 kg/m2
Exclusion
- Serum creatinine \> upper limit of normal
- Proteinuria (albumin/creatinine ratio \> 300 mg/g)
- Dysuria and/or urinary tract infection
- Significant renal, hepatic or cardiovascular diseases
- Ketosis
- Hypertension
- Severe gastrointestinal diseases
Key Trial Info
Start Date :
March 26 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2009
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT00621868
Start Date
March 26 2008
End Date
March 14 2009
Last Update
November 12 2024
Active Locations (8)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Hokkaidou, Japan
4
Kansai, Japan