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

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ClinicalTrials.gov Identifier: NCT01097681
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ASP1941 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : February 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Normal renal function group Drug: ASP1941
oral
Experimental: Mild renal impairment group Drug: ASP1941
oral
Experimental: Moderate renal impairment group Drug: ASP1941
oral


Outcome Measures
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Primary Outcome Measures :
  1. Plasma concentration of ASP1941 [ Time Frame: For 72 hours after dosing ]

Secondary Outcome Measures :
  1. Urinary levels of ASP1941 [ Time Frame: For 72 hours after dosing ]
  2. Urinary glucose excretion [ Time Frame: For 72 hours after dosing ]
  3. Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: For 72 hours after dosing ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01097681


Locations
Japan
Kansai, Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Link to Results on JAPIC - enter 150715 in the JapicCTI-RNo. field  This link exits the ClinicalTrials.gov site
Link to results on Astellas Clinical Study Results Web site  This link exits the ClinicalTrials.gov site

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01097681     History of Changes
Other Study ID Numbers: 1941-CL-0073
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
ASP1941
Diabetes mellitus
Urinary glucose excretion

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases