Expired Study
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San Antonio, Texas 78229


Purpose:

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


Study summary:

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


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


Study is Available At:


Original ID:

1941-CL-0016


NCT ID:

NCT00790660


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Astellas Pharma Inc


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

61


Enrollment Type:

Actual


Overall Contact Information

Official Name:use Central Contact
Study Director
Astellas Pharma Global Development

Study Dates

Start Date:October 23, 2008
Completion Date:March 6, 2009
Completion Type:Actual
Primary Completion Date:March 6, 2009
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 29, 2018
First Received Date:November 11, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Evaluation of routine PK and PD parameters
Time Frame:6 Weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Evaluation of safety through clinical safety labs and adverse events
Time Frame:6 Weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:ASP1941
Description:Oral
Arm Name:ASP1941 Medium Dose
Intervention Type:Drug
Name:Placebo
Description:Oral
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Oral
Study Arm Type:Experimental
Arm Name:ASP1941 High Dose
Description:Oral
Study Arm Type:Experimental
Arm Name:ASP1941 Medium Dose
Description:Oral
Study Arm Type:Experimental
Arm Name:ASP1941 Low Dose
Description:Oral
Study Arm Type:Experimental
Arm Name:ASP1941 Lowest Dose
Description:Oral

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astellas Pharma Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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