A Study to Assess Safety and Efficacy of ASP1941 in Combi... | NCT01316107

Studies
A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients

NCT01316107

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

May 30, 2025Actual

Enrollment

122Actual

Phase

Phase 3

Conditions

Type 2 Diabetes Mellitus

Interventions

ipragliflozin
nateglinide

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With Nateglinide in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Nateglinide Alone

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

Jan 15, 2011Actual

Primary Completion Date

Oct 19, 2012Actual

Completion Date

Oct 19, 2012Actual

First Submitted Date

Mar 14, 2011

First Submission Date that Met QC Criteria

Mar 14, 2011

First Posted Date

Mar 16, 2011Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2025

Last Update Posted Date

May 30, 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

Description Module

Brief Summary

This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.

Detailed Description

This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on Nateglinide alone more than 4 weeks. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASP group	Experimental	Concomitant administration of ASP1941 and nateglinide	Drug: ipragliflozin Drug: nateglinide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ipragliflozin	Drug	oral	ASP group	ASP1941

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change from baseline in hemoglobin A1c (HbA1c)		baseline and for 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetic patients receiving with Nateglinide mono-therapy for at least 4 weeks
HbA1c value between 6.5 and 9.5%
Body Mass Index (BMI) 20.0 - 45.0 kg/m2

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Central Contact	Astellas Pharma Inc	Study Chair

Label	URL
Link to results on Astellas Clinical Study Results website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

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/.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C572941	ipragliflozin
D000077715	Nateglinide

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Hokkaido			Japan