Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014