A Study to Assess the Pharmacokinetics, Pharmacodynamics... | NCT01097681

Studies
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment

NCT01097681

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Nov 12, 2024Actual

Enrollment

25Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

ASP1941

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

An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function

Status Module

Record Verification Date

Nov 2024

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

Feb 16, 2010Actual

Primary Completion Date

Jun 18, 2010Actual

Completion Date

Jun 18, 2010Actual

First Submitted Date

Mar 31, 2010

First Submission Date that Met QC Criteria

Mar 31, 2010

First Posted Date

Apr 2, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2024

Last Update Posted Date

Nov 12, 2024Actual

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

The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.

Detailed Description

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal renal function group	Experimental	oral	Drug: ASP1941
Mild renal impairment group	Experimental	oral	Drug: ASP1941
Moderate renal impairment group	Experimental	oral	Drug: ASP1941

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	oral	Mild renal impairment group Moderate renal impairment group Normal renal function group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentration of ASP1941		For 72 hours after dosing

Secondary Outcomes

Measure	Description	Time Frame
Urinary levels of ASP1941		For 72 hours after dosing
Urinary glucose excretion		For 72 hours after dosing
Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetic patients for at least 12 weeks
Fasting plasma glucose level of < 240 mg/dL
Body Mass Index ( BMI )20.0 - 35.0kg/m2
GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2

Exclusion Criteria:

Type 1 diabetes mellitus patients
Receiving insulin within 12 weeks before screening
Diabetic ketoacidosis
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

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Label	URL
Link to results on Astellas Clinical Study Results Web site	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

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Kansai			Japan