A Phase 3 interventional study of ipragliflozin in Type 2 Diabetes Mellitus, sponsored by Astellas Pharma Inc. Completed at 7 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment
The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.
Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 182 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ASP1941 will be administered before meal
Drug: ipragliflozin
ASP1941 will be administered after meal
Drug: ipragliflozin
oral
Also known as: ASP1941
HbA1c
Time frame: For 52 weeks
Fasting plasma glucose
Time frame: For 52 weeks
Fasting serum insulin
Time frame: For 52 weeks
Plasma levels of ASP1941 for population PK analysis
Time frame: For 52 weeks
Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs
Time frame: For 52 weeks
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc