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A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
This study is ongoing, but not recruiting participants.
Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00790660
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: ASP1941
Drug: Placebo
 Phase II

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Evaluation of safety through clinical safety labs and adverse events [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of routine PK and PD parameters [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ASP1941 Lowest Dose: Experimental Drug: ASP1941
Oral
ASP1941 Low Dose: Experimental Drug: ASP1941
Oral
ASP1941 Medium Dose: Experimental Drug: ASP1941
Oral
ASP1941 High Dose: Experimental Drug: ASP1941
Oral
Placebo: Placebo Comparator Drug: Placebo
Oral

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790660

Locations
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: use Central Contact Astellas Pharma US, Inc.
  More Information

Responsible Party: Astellas Pharma US, Inc. ( Sr Manager Clinical Trials Registry )
Study ID Numbers: 1941-CL-0016
Study First Received: November 11, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00790660  
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Type 2 Diabetes Mellitus
ASP1941

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
 Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009



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