NCT01225081

Brief Summary

This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and pioglitazone in patients with diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2012

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

October 19, 2010

Last Update Submit

May 25, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

ASP1941Diabetes mellituspioglitazone

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c

    Baseline and for 24 weeks

Secondary Outcomes (3)

  • Change from baseline in fasting plasma glucose

    Baseline and for 24 weeks

  • Change from baseline in fasting serum insulin

    Baseline and for 24 weeks

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

    For 52 weeks

Study Arms (2)

ASP group

EXPERIMENTAL

ASP1941 and pioglitazone

Drug: ipragliflozinDrug: Pioglitazone

Placebo group

PLACEBO COMPARATOR

placebo and pioglitazone

Drug: PlaceboDrug: Pioglitazone

Interventions

ipragliflozinDRUG

oral

Also known as: ASP1941
ASP group
PlaceboDRUG

oral

Placebo group
PioglitazoneDRUG

oral

Also known as: Actos
ASP groupPlacebo group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patients receiving pioglitazone mono-therapy for at least 4 weeks
  • HbA1c value between 7.0 and 9.5%
  • Body Mass Index (BMI) 20.0 - 45.0 kg/m2

You may not qualify if:

  • 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
  • Heart failure patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31606880DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

ipragliflozinPioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 20, 2010

Study Start

September 15, 2010

Primary Completion

April 28, 2012

Study Completion

April 28, 2012

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

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/.

Locations

JP(7)