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A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01097681
First Posted: April 2, 2010
Last Update Posted: January 20, 2016
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
March 31, 2010
April 2, 2010
January 20, 2016
February 2010
June 2010   (Final data collection date for primary outcome measure)
Plasma concentration of ASP1941 [ Time Frame: For 72 hours after dosing ]
Same as current
Complete list of historical versions of study NCT01097681 on ClinicalTrials.gov Archive Site
  • Urinary levels of ASP1941 [ Time Frame: For 72 hours after dosing ]
  • Urinary glucose excretion [ Time Frame: For 72 hours after dosing ]
  • Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: For 72 hours after dosing ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Type 2 Diabetes Mellitus
Drug: ASP1941
oral
  • Experimental: Normal renal function group
    Intervention: Drug: ASP1941
  • Experimental: Mild renal impairment group
    Intervention: Drug: ASP1941
  • Experimental: Moderate renal impairment group
    Intervention: Drug: ASP1941
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetic patients for at least 12 weeks
  • Fasting plasma glucose level of < 240 mg/dL
  • Body Mass Index ( BMI )20.0 - 35.0kg/m2
  • GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2

Exclusion Criteria:

  • Type 1 diabetes mellitus patients
  • Receiving insulin within 12 weeks before screening
  • Diabetic ketoacidosis
  • Dysuria and/or urinary tract infection, genital infection
  • Significant renal, hepatic or cardiovascular diseases
  • Severe gastrointestinal diseases
Sexes Eligible for Study: All
20 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01097681
1941-CL-0073
No
Not Provided
Plan to Share IPD: Undecided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
January 2016

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