A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus
- Conditions
- -E10 Insulin-dependent diabetes mellitusInsulin-dependent diabetes mellitusE10
- Registration Number
- PER-013-10
- Lead Sponsor
- Astellas Pharma Global Development, Inc. (APGD),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The subject has a HbA1c value between 6.8 and 9.5% in Visit 1 AND has a HbA1c value between 7.0 and 9.5%, inclusive, in Visit 3 And does not meet any of the fasting criteria for fasting plasma glucose ( GPA) (see Section 3.4).
• The subject is a virgin to antidiabetic medications; Or you are receiving a single low-dose antidiabetic agent for a double combination oral therapy (<50% of the maximum doses of each component), and you are willing and can safely discontinue the anti-diabetic therapy in the Selection (for 8 weeks at least before of the first dose of the study medication) and throughout the study (24 weeks in total).
• The subject is on a stable diet and exercise program (at least for 6 weeks before Selection) and is willing to continue in this program during the study.
• The subject has a body mass index (BMI) of 20-45 kg / m ^ 2 in Visit 1.
• The subject has some confirmed complication of DMT2, indicating a late state of the disease, which in the opinion of the Investigator must prevent the participation of! subject.
• The subject has type l diabetes mellitus.
• The subject needs insulin therapy or has received insulin within 3 months before Visit 1, except for acute use of <7 days.
• The subject has a serum creatinine value greater than the normal upper limit on Visit 1 or 3.
• The subject has an ALT and / or AST value greater than 3 times the normal upper limit or has a total bilirubin value greater than 2 times the normal upper limit on Visit 1 or 3.
• The subject has a urine microalbumin / creatinine ratio> 300 mg / g on Visit 1 or 3.
• The subject has a symptomatic urinary tract infection or a symptomatic genital infection at any time during the Selection or the Pre-Inclusion Period with Placebo, even immediately before random assignment at Visit 4.
• The subject has persistent severe uncontrolled hypertension, indicated by a systolic blood pressure> 180 mmHg or a diastolic blood pressure> 110 mmHg taken in a sitting or supine position after 5 minutes of rest in 2 measurements at least (difference of 30 minutes between each) in Visits 1, 2 or 3.
• The subject has significant cardiovascular disease, such as myocardial infarction or had a vascular intervention (for example, angioplasty or stent) within 3 months before Visit 1, or a history of heart failure (NYHA Class III-IV).
• The subject is currently receiving an excluded medication (loop diuretics or systemic corticosteroids) or is not willing to suspend a restricted medication during the study.
• The subject has a history of lactic acidosis.
• The subject has a history of drug or alcohol abuse / dependence within 12 months prior to Visit 1, as defined in the Diagnostic and Statistics Manual-IV (DSM-IV).
• The subject had a malignancy in the last 5 years, except for basal or squamous cell carcinoma of the skin or cervical carcinoma in situ successfully treated.
• The subject has confirmed or suspected hypersensitivity to ASP1941 or metformin or its components.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Through routine laboratory analysis performed during the study.<br>Measure:Mean change from baseline in Hemoglobin A1c (HbA1c)<br>Timepoints:12 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Through routine laboratory analysis performed during the study.<br>Measure:Mean change from baseline in fasting plasma glucose (FPG)<br>Timepoints:12 weeks<br>;<br>Outcome name:Through routine laboratory analysis performed during the study.<br>Measure:Proportion of subjects achieving target goal of HbA1c <7.0%<br>Timepoints:12 weeks<br>;<br>Outcome name:Through routine laboratory analysis performed during the study.<br>Measure:Proportion of subjects achieving target goal of HbA1c <6.5%<br>Timepoints:12 weeks<br>