Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
| Verified date | August 2018 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | March 26, 2010 |
| Est. primary completion date | March 26, 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Type 2 diabetic patients for at least 12 weeks - HbA1c value between 7.0 and 10.0% at screening - Fasting plasma glucose = 126mg/dL and < 240mg/dL at screening - Body Mass Index (BMI) 20.0 - 45.0 kg/m2. Exclusion Criteria: - Type 1 diabetes mellitus patients - Serum creatinine > upper limit of normal - Proteinuria(albumin/creatinine ratio > 300mg/g) - Dysuria and/or urinary tract infection - Significant renal, hepatic or cardiovascular diseases - Severe gastrointestinal diseases |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in plasma glucose levels | On day 14 | ||
| Secondary | Urinary glucose excursion | On day 14 | ||
| Secondary | Pharmacokinetic parameter of ASP1941 | On day 14 | ||
| Secondary | Safety by adverse events, routine safety laboratories and vital signs. | During treatment | ||
| Secondary | Change in serum insulin levels | On day 14 |
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