A Study to Evaluate the Effect of ASP1941 in Adult Patien... | NCT01071850

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2010Actual

Primary Completion Date

Apr 11, 2011Actual

Completion Date

Apr 11, 2011Actual

First Submitted Date

Feb 18, 2010

First Submission Date that Met QC Criteria

Feb 18, 2010

First Posted Date

Feb 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 29, 2012

Certification/Extension First Submitted that Passed QC Review

Apr 29, 2012

Certification/Extension First Posted Date

May 1, 2012Estimated

Last Update Submitted Date

May 20, 2025

Last Update Posted Date

May 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

412Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASP1941 lowest dose	Experimental	oral tablet	Drug: ipragliflozin
ASP1941 low dose	Experimental	oral tablet	Drug: ipragliflozin
ASP1941 high dose	Experimental	oral tablet	Drug: ipragliflozin
ASP1941 highest dose	Experimental	oral tablet	Drug: ipragliflozin
Metformin	Active Comparator	oral tablet	Drug: Metformin
Placebo	Placebo Comparator	oral tablet	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ipragliflozin	Drug	oral tablet	ASP1941 high dose ASP1941 highest dose ASP1941 low dose ASP1941 lowest dose

Measure	Description	Time Frame
Mean change from baseline in Hemoglobin A1c (HbA1c)		12 weeks

Measure	Description	Time Frame
Mean change from baseline in fasting plasma glucose (FPG)		12 weeks
Proportion of subjects achieving target goal of HbA1c <7.0%		12 weeks
Proportion of subjects achieving target goal of HbA1c <6.5%

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has been diagnosed with type 2 diabetes
Subject has a HbA1c value between 6.8 and 9.5%
Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
Subject is on a stable diet and exercise program
Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study

Exclusion Criteria:

Subject has type 1 diabetes mellitus
Subject is using insulin therapy
Subject has a serum creatinine higher than upper limit of normal
Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
Subject has persistent, uncontrolled severe hypertension as indicated by a

systolic blood pressure >180 mmHg or a diastolic blood pressure of

>110mmHg

Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
Subject is known to have hepatitis or be a carrier of hepatitis B surface

antigen, hepatitis C virus antibody or is known positive for HIV1 and/or

HIV2

Subject has a history of lactic acidosis
Subject has a history of drug and alcohol abuse/dependency within last 12

months

Subject has had a malignancy in the last 5 years, except for successfully

treated basal or squamous cell carcinoma of the skin or of the cervix

Subject has a symptomatic urinary tract infection or genital infection
Female subject is lactating
Subject has an unstable medical or psychiatric illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Astellas Pharma Global Development	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Parkway Medical Center		Birmingham	Alabama	35215	United States
Winston Technology Research, LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31606880	Derived	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.
23276620	Derived

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
C572941	ipragliflozin
D008687	Metformin

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals