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CompletedNCT01057628Updated May 30, 2025

A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients

A Phase 3 interventional study of ipragliflozin and placebo in Type 2 Diabetes Mellitus, sponsored by Astellas Pharma Inc. Completed at 5 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

Phase
Phase 3
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Blood glucose
  • ASP1941
  • Diabetes mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 130 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Type 1 diabetes mellitus patients
  • Serum creatinine > upper limit of normal
  • Proteinuria (albumin/creatinine ratio > 300mg/g)
  • Dysuria and/or urinary tract infection, genital infection
  • Significant renal, hepatic or cardiovascular diseases
  • Severe gastrointestinal diseases
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    ASP1941 group

    oral

    Drug: ipragliflozin

  • Placebo comparator
    placebo group

    oral

    Drug: placebo

Interventions

  • Drugipragliflozin

    oral

    Also known as: ASP1941

  • Drugplacebo

    oral

06

What researchers measure

Primary outcomes

  1. change from baseline in HbA1c

    Time frame: 16 weeks

Secondary outcomes

  1. change from baseline in fasting plasma glucose

    Time frame: 16 weeks

  2. change from baseline in fasting serum insulin

    Time frame: 16 weeks

  3. safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)

    Time frame: During treatment

07

Study locations

5 sites
  • Hokkaido, Japan
  • Kansai, Japan
  • Kantou, Japan
  • Kyushu, Japan
  • Touhoku, Japan
08

References and documents

Publications

  • Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12. PubMed 31606880 ↗

Individual participant data

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/.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01057628
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Jan 27, 2010
Start date
Jan 13, 2010
Primary completion
Nov 6, 2010
Completion
Nov 6, 2010
Last update
May 30, 2025

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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