NCT01316094

Brief Summary

This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

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

Timeline
Completed

Started Jan 2011

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

8 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

January 18, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2012

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

March 14, 2011

Last Update Submit

May 19, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

PharmacokineticsASP1941Renal impairment

Outcome Measures

Primary Outcomes (1)

  • changes in Hemoglobin A1c (HbA1c)

    baseline and 24 weeks

Secondary Outcomes (4)

  • changes in fasting plasma glucose

    baseline and 24 weeks

  • changes in fasting serum insulin level

    baseline and 24 weeks

  • changes in eGFR (estimated glomerular filtration rate)

    baseline and 52 weeks

  • safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs

    for 52 weeks

Study Arms (2)

ASP group

EXPERIMENTAL

oral

Drug: ASP1941

placebo group

PLACEBO COMPARATOR

oral

Drug: placebo

Interventions

ASP1941DRUG

oral

ASP group
placeboDRUG

oral

placebo group

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes mellitus patient
  • subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone)
  • estimated GFR value based on the Japanese GFR estimation equation of ≥ 30 mL/min/1.73 m2 and \< 90 mL/min/1.73 m2
  • HbA1C value between 6.5 and 8.5%
  • body mass index (BMI) 29.0 - 45.0 kg/m2

You may not qualify if:

  • type 1 diabetes mellitus patients
  • proliferative diabetic retinopathy
  • subject has received insulin within 12 weeks before the study
  • subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Publications (2)

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PMID: 38770818DERIVED

  • 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 2Renal Insufficiency

Interventions

ipragliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • 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

March 14, 2011

First Posted

March 16, 2011

Study Start

January 18, 2011

Primary Completion

November 28, 2012

Study Completion

November 28, 2012

Last Updated

May 22, 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(8)