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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ASP1941

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring ASP1941, Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

ASP1941 Lowest Dose

ASP1941 Low Dose

ASP1941 Medium Dose

ASP1941 High Dose

Placebo

Arm Description

Oral

Outcomes

Primary Outcome Measures

Evaluation of safety through clinical safety labs and adverse events

Secondary Outcome Measures

Evaluation of routine PK and PD parameters

Full Information

NCT ID

NCT00790660

First Posted

November 11, 2008

Last Updated

March 29, 2018

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00790660

Brief Title

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

Official Title

A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

October 23, 2008 (Actual)

Primary Completion Date

March 6, 2009 (Actual)

Study Completion Date

March 6, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

ASP1941, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASP1941 Lowest Dose

Arm Type

Experimental

Arm Description

Oral

Arm Title

ASP1941 Low Dose

Arm Type

Experimental

Arm Description

Oral

Arm Title

ASP1941 Medium Dose

Arm Type

Experimental

Arm Description

Oral

Arm Title

ASP1941 High Dose

Arm Type

Experimental

Arm Description

Oral

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral

Intervention Type

Drug

Intervention Name(s)

ASP1941

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Evaluation of safety through clinical safety labs and adverse events

Time Frame

6 Weeks

Secondary Outcome Measure Information:

Title

Evaluation of routine PK and PD parameters

Time Frame

6 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

use Central Contact

Organizational Affiliation

Astellas Pharma Global Development

Official's Role

Study Director

Facility Information:

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://astellasclinicalstudyresults.com/study.aspx?ID=3

Description

Link to results on the Astellas Clinical Study Results website.

Learn more about this trial

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

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