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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00790660 |
This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: ASP1941 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ASP1941 Lowest Dose: Experimental |
Drug: ASP1941
Oral
|
ASP1941 Low Dose: Experimental |
Drug: ASP1941
Oral
|
ASP1941 Medium Dose: Experimental |
Drug: ASP1941
Oral
|
ASP1941 High Dose: Experimental |
Drug: ASP1941
Oral
|
Placebo: Placebo Comparator |
Drug: Placebo
Oral
|
Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trials Registry ) |
Study ID Numbers: | 1941-CL-0016 |
Study First Received: | November 11, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00790660 |
Health Authority: | United States: Food and Drug Administration |
Type 2 Diabetes Mellitus ASP1941 |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |