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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.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: November 11, 2008
Last updated: June 5, 2015
Last verified: June 2015
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 Blind (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

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
Experimental: ASP1941 Low Dose Drug: ASP1941
Experimental: ASP1941 Medium Dose Drug: ASP1941
Experimental: ASP1941 High Dose Drug: ASP1941
Placebo Comparator: Placebo Drug: Placebo

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00790660

United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: use Central Contact Astellas Pharma Global Development
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00790660     History of Changes
Other Study ID Numbers: 1941-CL-0016
Study First Received: November 11, 2008
Last Updated: June 5, 2015

Keywords provided by Astellas Pharma Inc:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 25, 2017