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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00790660
First received: November 11, 2008
Last updated: February 26, 2010
Last verified: February 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 61
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 Lowest Dose Drug: ASP1941
Oral
Experimental: ASP1941 Low Dose Drug: ASP1941
Oral
Experimental: ASP1941 Medium Dose Drug: ASP1941
Oral
Experimental: ASP1941 High Dose Drug: ASP1941
Oral
Placebo Comparator: Placebo 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 Global Development
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT00790660     History of Changes
Other Study ID Numbers: 1941-CL-0016
Study First Received: November 11, 2008
Last Updated: February 26, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013