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

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.
 
ClinicalTrials.gov Identifier: NCT00790660
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE November 11, 2008
First Posted Date  ICMJE November 13, 2008
Last Update Posted Date April 2, 2018
Actual Study Start Date  ICMJE October 23, 2008
Actual Primary Completion Date March 6, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2008)
Evaluation of safety through clinical safety labs and adverse events [ Time Frame: 6 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2008)
Evaluation of routine PK and PD parameters [ Time Frame: 6 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
Official Title  ICMJE 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
Brief Summary This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus
Detailed Description Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: ASP1941
    Oral
  • Drug: Placebo
    Oral
Study Arms  ICMJE
  • Experimental: ASP1941 Lowest Dose
    Oral
    Intervention: Drug: ASP1941
  • Experimental: ASP1941 Low Dose
    Oral
    Intervention: Drug: ASP1941
  • Experimental: ASP1941 Medium Dose
    Oral
    Intervention: Drug: ASP1941
  • Experimental: ASP1941 High Dose
    Oral
    Intervention: Drug: ASP1941
  • Placebo Comparator: Placebo
    Oral
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2009)
61
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2008)
60
Actual Study Completion Date  ICMJE March 6, 2009
Actual Primary Completion Date March 6, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00790660
Other Study ID Numbers  ICMJE 1941-CL-0016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: use Central Contact Astellas Pharma Global Development
PRS Account Astellas Pharma Inc
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP