Status:
COMPLETED
A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus
Detailed Description
Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.
Eligibility Criteria
Inclusion
- Established diagnosis of type 2 diabetes mellitus
- HbA1c value between 7.0 and 10.0%
- Body mass index between 20 and 45 kg/m2
Exclusion
- Established diagnosis of type 1 diabetes mellitus
- Serum creatinine \> upper limit of normal range
- Proteinuria (microalbumin/creatinine ratio \> 300 mg/g)
- Urinary tract infection
- Severe uncontrolled Hypertension
- Significant renal, hepatic or cardiovascular disease
- HIV Positive
- History of drug or alcohol abuse/dependency
Key Trial Info
Start Date :
October 23 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00790660
Start Date
October 23 2008
End Date
March 6 2009
Last Update
November 14 2024
Active Locations (1)
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1
San Antonio, Texas, United States, 78229