NCT01505426

Brief Summary

To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_3

Geographic Reach
2 countries

12 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

November 28, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2013

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

January 4, 2012

Last Update Submit

November 8, 2024

Conditions

Type II Diabetes Mellitus

Keywords

ASP1941ipragliflozinurine glucosemetforminplasma glucose

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c from baseline to end of treatment

    Baseline and up to 24 weeks

Secondary Outcomes (5)

  • Change in fasting plasma glucose level

    Baseline and up to 24 weeks

  • Change in fasting serum insulin level

    Baseline and up to 24 weeks

  • Change in body weight

    Baseline and up to 24 weeks

  • Change in waist circumference

    Baseline and up to 24 weeks

  • Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG

    For 24 weeks

Study Arms (2)

ASP1941 group

EXPERIMENTAL

ASP1941 + metformin

Drug: ASP1941Drug: metformin

placebo group

PLACEBO COMPARATOR

placebo + metformin

Drug: metforminDrug: Placebo

Interventions

ASP1941DRUG

oral

Also known as: ipragliflozin
ASP1941 group
metforminDRUG

oral, concomitant use

ASP1941 groupplacebo group
PlaceboDRUG

oral

placebo group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
  • Stable diet and exercise program for at least 8 weeks before the study
  • On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
  • BMI of 20.0 to 45.0 kg/m2
  • A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose

You may not qualify if:

  • Type 1 diabetes mellitus
  • Proliferative diabetic retinopathy
  • Receiving insulin within 12 weeks prior to the study
  • History of clinically significant renal disease(s)
  • Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
  • Urinary tract infection or genital infection
  • Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
  • History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
  • Severe infection, serious trauma, or perioperative subject
  • Known or suspected hypersensitivity to ASP1941
  • History of treatment with ASP1941
  • Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
  • Serum creatinine value exceeding the upper limit of normal range
  • Urinary microalbumin/urinary creatinine ratio \>300 mg/g

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Wŏnju, South Korea

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

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 2Glycosuria

Interventions

ipragliflozinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

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

January 4, 2012

First Posted

January 6, 2012

Study Start

November 28, 2011

Primary Completion

January 14, 2013

Study Completion

January 14, 2013

Last Updated

November 12, 2024

Record last verified: 2024-11

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

KR(8)TW(4)