A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/17/2018 |
| Start Date: | October 23, 2008 |
| End Date: | March 6, 2009 |
A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus
This study is intended to assess safety and tolerability of ASP1941 compared to placebo in
adult subjects with type 2 diabetes mellitus
adult subjects with type 2 diabetes mellitus
Trial includes a two week washout period before entering the treatment period for subjects on
oral anti-diabetic medication.
oral anti-diabetic medication.
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
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