A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
- Registration Number
- NCT00790660
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP1941 Lowest Dose ASP1941 Oral ASP1941 Medium Dose ASP1941 Oral ASP1941 Low Dose ASP1941 Oral ASP1941 High Dose ASP1941 Oral Placebo Placebo Oral
- Primary Outcome Measures
Name Time Method Evaluation of safety through clinical safety labs and adverse events 6 Weeks
- Secondary Outcome Measures
Name Time Method Evaluation of routine PK and PD parameters 6 Weeks