A Study of ASP1941 in Japanese Patients With Type 2 Diabe... | NCT01023945

Studies
A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

NCT01023945

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Nov 12, 2024Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

ASP1941
Placebo

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

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

Nov 7, 2009Actual

Primary Completion Date

Mar 26, 2010Actual

Completion Date

Mar 26, 2010Actual

First Submitted Date

Nov 30, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 2, 2009Estimated

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 purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASP1941 high dose group	Experimental	oral	Drug: ASP1941
ASP1941 low dose group	Experimental	oral	Drug: ASP1941
Placebo group	Placebo Comparator	oral	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	oral	ASP1941 high dose group ASP1941 low dose group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in plasma glucose levels		On day 14

Secondary Outcomes

Measure	Description	Time Frame
Urinary glucose excursion		On day 14
Pharmacokinetic parameter of ASP1941		On day 14
Safety by adverse events, routine safety laboratories and vital signs.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetic patients for at least 12 weeks
HbA1c value between 7.0 and 10.0% at screening
Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening
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
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

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32839028	Derived	Toyoshima J, Saito M, Kaibara A, Isaka H, Sakatani T. Comparison of the Pharmacokinetic and Pharmacodynamic Relationship of Ipragliflozin Between Patients With Type 1 and Type 2 Diabetes Mellitus. Clin Ther. 2020 Sep;42(9):1787-1798.e3. doi: 10.1016/j.clinthera.2020.07.009. Epub 2020 Aug 21.

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