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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:
ClinicalTrials.gov Identifier:
NCT00790660
First Posted: November 13, 2008
Last Update Posted: July 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Evaluation of routine PK and PD parameters [ Time Frame: 6 Weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00790660     History of Changes
Other Study ID Numbers: 1941-CL-0016
First Submitted: November 11, 2008
First Posted: November 13, 2008
Last Update Posted: July 3, 2015
Last Verified: June 2015

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