A Phase 3 interventional study of ipragliflozin and Placebo 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
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin in patients with diabetes mellitus.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 168 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 and metformin
Drug: ipragliflozin · Drug: metformin
placebo and metformin
Drug: Placebo · Drug: metformin
oral
Also known as: ASP1941
oral
oral
Also known as: Metgluco, Melbin, Glycoran
Change from baseline in HbA1c
Time frame: Baseline and for 24 weeks
Change from baseline in fasting plasma glucose
Time frame: Baseline and for 24 weeks
Change from baseline in fasting serum insulin
Time frame: Baseline and for 24 weeks
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (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