A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Phase III Study of ASP1941 -A Phase III, Randomized, Double-Blind, Placebo-controlled, Monotherapy Study to Assess the Efficacy, Safety, and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Actual Study Start Date :
January 13, 2010
Actual Primary Completion Date :
November 6, 2010
Actual Study Completion Date :
November 6, 2010
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Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Type 2 diabetic patients for at least 12 weeks
HbA1c value between 7.0 and 10.0%
Body Mass Index (BMI) 20.0 - 45.0 kg/m2
Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Keywords provided by Astellas Pharma Inc:
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs