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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01097681 |
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Date of registration:
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31/03/2010 |
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Primary sponsor: |
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Public title:
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A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
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Scientific title:
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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 |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01097681 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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Japan
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Contacts
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Name:
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Use Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma Inc |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
79 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: ASP1941
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Primary Outcome(s)
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Plasma concentration of ASP1941
[Time Frame: For 72 hours after dosing]
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Secondary Outcome(s)
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Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs
[Time Frame: For 72 hours after dosing]
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Urinary glucose excretion
[Time Frame: For 72 hours after dosing]
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Urinary levels of ASP1941
[Time Frame: For 72 hours after dosing]
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Secondary ID(s)
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1941-CL-0073
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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