A Study to Assess the Safety and Tolerability of ASP1941... | NCT00790660

Studies
A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.

NCT00790660

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Nov 14, 2024Actual

Enrollment

61Actual

Phase

Phase 2

Conditions

Diabetes Mellitus, Type 2

Interventions

ASP1941
Placebo

Countries

United States

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

Oct 23, 2008Actual

Primary Completion Date

Mar 6, 2009Actual

Completion Date

Mar 6, 2009Actual

First Submitted Date

Nov 11, 2008

First Submission Date that Met QC Criteria

Nov 11, 2008

First Posted Date

Nov 13, 2008Estimated

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

Feb 26, 2010

Certification/Extension First Submitted that Passed QC Review

Feb 26, 2010

Certification/Extension First Posted Date

Mar 1, 2010Estimated

Last Update Submitted Date

Nov 8, 2024

Last Update Posted Date

Nov 14, 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

This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus

Detailed Description

Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.

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

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASP1941 Lowest Dose	Experimental	Oral	Drug: ASP1941
ASP1941 Low Dose	Experimental	Oral	Drug: ASP1941
ASP1941 Medium Dose	Experimental	Oral	Drug: ASP1941
ASP1941 High Dose	Experimental	Oral	Drug: ASP1941
Placebo	Placebo Comparator	Oral	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	Oral	ASP1941 High Dose ASP1941 Low Dose ASP1941 Lowest Dose ASP1941 Medium Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of safety through clinical safety labs and adverse events		6 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of routine PK and PD parameters		6 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Established diagnosis of type 2 diabetes mellitus
HbA1c value between 7.0 and 10.0%
Body mass index between 20 and 45 kg/m2

Exclusion Criteria:

Established diagnosis of type 1 diabetes mellitus
Serum creatinine > upper limit of normal range
Proteinuria (microalbumin/creatinine ratio > 300 mg/g)
Urinary tract infection
Severe uncontrolled Hypertension
Significant renal, hepatic or cardiovascular disease
HIV Positive
History of drug or alcohol abuse/dependency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
use Central Contact	Astellas Pharma Global Development	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		San Antonio	Texas	78229	United States

References Module

Citations

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases