A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients
Overview[ - collapse ][ - ]
Purpose | This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin in patients with diabetes mellitus. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: ASP1941 Drug: Placebo Drug: metformin |
Phase | Phase 3 |
Sponsor | Astellas Pharma Inc |
Responsible Party | Astellas Pharma Inc |
ClinicalTrials.gov Identifier | NCT01135433 |
First Received | June 1, 2010 |
Last Updated | January 10, 2012 |
Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | June 1, 2010 |
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Last Updated Date | January 10, 2012 |
Start Date | May 2010 |
Estimated Primary Completion Date | December 2011 |
Current Primary Outcome Measures | Change from baseline in HbA1c [Time Frame: Baseline and for 24 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients |
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Official Title | A Phase 3, Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone |
Brief Summary | This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin in patients with diabetes mellitus. |
Detailed Description | This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with metformin in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with metformin alone. The effects of ASP1941 are compared with those of placebo. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: ASP1941 oral Drug: Placebo oral Drug: metformin oral Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 168 |
Estimated Completion Date | December 2011 |
Estimated Primary Completion Date | December 2011 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 weeks - HbA1c value between 7.0 and 9.5% - Body Mass Index (BMI) 20.0 - 45.0 kg/m2 Exclusion Criteria: - Type 1 diabetes mellitus patients - Serum creatinine > upper limit of normal - Estimated GFR < 60ml/min/1.73m2 - Proteinuria (albumin/creatinine ratio > 300mg/g) - Dysuria and/or urinary tract infection, genital infection - Significant renal, hepatic or cardiovascular diseases - Severe gastrointestinal diseases |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Japan |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01135433 |
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Other Study ID Numbers | 1941-CL-0106 |
Has Data Monitoring Committee | No |
Information Provided By | Astellas Pharma Inc |
Study Sponsor | Astellas Pharma Inc |
Collaborators | Not Provided |
Investigators | Study Chair: Use Central Contact Astellas Pharma Inc |
Verification Date | January 2012 |
Locations[ + expand ][ + ]
Japan | Chubu, Japan |
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Japan | Chugoku, Japan |
Japan | Hokkaido, Japan |
Japan | Kansai, Japan |
Japan | Kantou, Japan |
Japan | Kyushu, Japan |
Japan | Touhoku, Japan |