A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Pioglitazone in Type 2 Diabetic Patients
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This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with pioglitazone in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with pioglitazone alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase III Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Alone
Actual Study Start Date :
September 15, 2010
Actual Primary Completion Date :
April 28, 2012
Actual Study Completion Date :
April 28, 2012
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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 receiving pioglitazone mono-therapy for at least 4 weeks
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
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action